PROTOCOL FOR SUBMISSION OF THESIS FOR THE AWARD OF

DEGREE OF DOCTOR OF MEDICINE (MD SPORTS MEDICINE)

SESSION: 2024 – 2027

GURU GOBIND SINGH INDRAPRASTHA UNIVERSITY,

NEW DELHI

COMPARISON OF EFFECTIVENESS OF FUNCTIONAL OUTCOME

OF ANTI-GRAVITY TREADMILL REHABILITATION AND
TRADITIONAL REHABILITATION IN ANTERIOR CRUCIATE
LIGAMENT RECONSTRUCTED PATIENTS

DR ANJU SINGAL
DEPARTMENT OF SPORTS MEDICINE SPORTS INJURY CENTRE
VARDHMAN MAHAVIR MEDICAL COLLEGE
AND SAFDARJUNG HOSPITAL,
NEW DELHI 110029

i
 PROTOCOL FOR SUBMISSION OF THESIS FOR THE AWARD OF
DEGREE OF DOCTOR OF MEDICINE (MD SPORTS MEDICINE)
SESSION: 2024 – 2027

COMPARISON OF EFFECTIVENESS OF FUNCTIONAL OUTCOME

OF ANTI-GRAVITY TREADMILL REHABILITATION AND
TRADITIONAL REHABILITATION IN ANTERIOR CRUCIATE
LIGAMENT RECONSTRUCTED PATIENTS

SIGNATURE OF THE CANDIDATE:

NAME OF THE CANDIDATE DR. ANJU SINGAL
POST-GRADUATE STUDENT,
SPORTS INJURY CENTER,
VMMC & SAFDARJUNG HOSPITAL,
NEW DELHI

SIGNATURE OF THE SUPERVISOR:

NAME OF THE SUPERVISOR Dr. PALLAV MISHRA
PROFESSOR, SPORTS INJURY CENTER,
VMMC & SAFDARJUNG HOSPITAL,
NEW DELHI

SIGNATURE OF THE H.O.D.:

NAME OF THE H.O.D. DR. DEEPAK JOSHI,
PROFESSOR AND CONSULTANT
DIRECTOR, SPORTS INJURY CENTER,
VMMC & SAFDARJUNG HOSPITAL,
NEW DELHI

ii
SIGNATURE OF THE PRINCIPAL:
NAME OF THE PRINCIPAL: DR. GEETIKA KHANNA,
DIRECTOR, PROFESSOR & PRINCIPAL
DEPARTMENT OF PATHOLOGY,
VMMC & SAFDARJUNG HOSPITAL,
NEW DELHI

SIGNATURE OF MEDICAL
SUPERINTENDENT:
NAME OF MEDICAL DR. SANDEEP BANSAL,
SUPERINTENDENT: DIRECTOR-PROFESSOR
DEPARTMENT OF CARDIOLOGY
MEDICAL SUPERINTENDENT
VMMC & SAFDARJUNG HOSPITAL,
NEW DELHI

iii
 DECLARATION

I wish to undertake a thesis project entitled ―COMPARISON OF EFFECTIVENESS OF

FUNCTIONAL OUTCOME OF ANTI-GRAVITY TREADMILL REHABILITATION AND

TRADITIONAL REHABILITATION IN ANTERIOR CRUCIATE LIGAMENT-

RECONSTRUCTED PATIENTS‖ to fulfill the essential requirement for the award of a

Doctor of Medicine (Sports Medicine) degree from Guru Gobind Singh Indraprastha

University, New Delhi.

I hereby declare that the thesis protocol does not violate the copyright action anyway, is free

of plagiarism, and that the ―questionnaires‖ and ―scores‖ being used are copyright-free or that

the necessary permission has been obtained from the copyright holders. The work does not

include any diagrams, figures, tables, and flowcharts which are copied from a journal or book

or infringe copyright.

SIGNATURE OF THE CANDIDATE:

NAME OF THE CANDIDATE DR. ANJU SINGAL
POST-GRADUATE STUDENT,
SPORTS INJURY CENTER,
VMMC & SAFDARJUNG HOSPITAL,
NEW DELHI

iv
 CERTIFICATE FROM INSTITUTION

It is certified that the study is feasible in the given time frame and that the institution has the

machinery and equipment and other essential prerequisites for conducting the study; and that

the study sample size has been calculated on the basis of relatable statistical formula, and that

it satisfies the requirements of study design and the proposed statistical analysis.

It is certified that the thesis plan is not a repetition of a similar study undertaken in the

previous five years in the university, and that the study is not based on a retrospective

collection or analyses of data from old patient case records, and that it does not employ any

―off-label drug trial‖.

We undertake that the participants enrolled in the thesis project will not have to bear any

financial burden on account of the investigations, devices, implants or drugs employed as a

part of the study, and that the study does not require us to partake of any obligation or any

favor from a pharmaceutical company, device manufacturer or medical supplier.

SIGNATURE OF THE CANDIDATE:

NAME OF THE CANDIDATE DR. ANJU SINGAL
POST-GRADUATE STUDENT,
SPORTS INJURY CENTER,
VMMC & SAFDARJUNG HOSPITAL,
NEW DELHI

SIGNATURE OF THE SUPERVISOR:

NAME OF THE SUPERVISOR Dr. PALLAV MISHRA
PROFESSOR, SPORTS INJURY CENTER,
VMMC & SAFDARJUNG HOSPITAL,
NEW DELHI

v
SIGNATURE OF THE H.O.D.:
NAME OF THE H.O.D. DR. DEEPAK JOSHI,
PROFESSOR AND CONSULTANT
DIRECTOR, SPORTS INJURY CENTER,
VMMC & SAFDARJUNG HOSPITAL,
NEW DELHI

vi
 UNDERTAKING FOR RANDOMIZED CONTROLLED STUDY

1. I will be responsible for getting the research registered with CTRI and will also inform

CTRI and all other relevant authorities regarding my activity/progress/serious adverse

effects in this regard.

2. I will also get ethical clearance from the Institutional Ethics Committee as well as from

any other competent regulatory authority, if required.

3. I hereby declare that GGSIPU/NMC/CTRI/ any other statutory authority guidelines are

being followed strictly.

4. I will also give an undertaking that the institution will not have any liability related to

compensation/insurance or any other statutory/financial obligations.

INVESTIGATOR SUPERVISOR
DR. ANJU SINGAL DR. PALLAV MISHRA
POST GRADUATE STUDENT PROFESSOR
SPORTS INJURY CENTER SPORTS INJURY CENTER
VMMC & SAFDARJUNG HOSPITAL, VMMC & SAFDARJUNG HOSPITAL,
NEW DELHI NEW DELHI
PHONE NO-7015628257 PHONE NO-

vii
 UNDERTAKING
I/We care to abide by the ethical guidelines for biomedical research on human subjects (as
per ICMR guidelines) while conducting the research project being submitted for ethical
committee consideration:
1) Project is considered essential for the advancement of knowledge and for benefit of all.
2) Only subjects who volunteer for the study will be included and their informed consent.
shall be obtained prior to the commencement of the study & the subjects will be kept
fully. appraised of all the consequences.
3) Privacy and confidentiality of the subjects shall be maintained and without the consent of
the subject no disclosure shall be made.
4) Proper precautions shall be undertaken so as to minimize the risk and prevent
irreversible. side effects.
5) Study shall be conducted by professionally competent people in a fair, honest, impartial
way. and transparent manner.
6) Researcher will be responsible for maintaining proper records.
7) Study will be conducted keeping in view public interest at large.
8) Study reports, materials & data will be preserved.
9) Results of the study will be made known through scientific publications.
10) Professional and moral responsibilities will be of the researchers, directly or indirectly.
connected with the research.
11) Only those drugs which are approved by the Drug Controller of India for a specific
purpose will be used in the research.
12) The protocol has been discussed in my department and has been approved.

DR. ANJU SINGAL DR. PALLAV MISHRA

POST GRADUATE STUDENT SUPERVISOR

viii
 INSTITUTIONAL REVIEW BOARD CERTIFICATE

The Institutional Review Board/Thesis Protocol Review Committee of VMMC and

Safdarjung Hospital has reviewed and discussed the research proposal entitled
“COMPARISON OF EFFECTIVENESS OF FUNCTIONAL OUTCOME OF ANTI-
GRAVITY TREADMILL REHABILITATION AND TRADITIONAL REHABILITATION
IN ANTERIOR CRUCIATE LIGAMENT-RECONSTRUCTED PATIENTS.” on .

The Institutional Review Board duly reviewed the thesis protocol in line with the formally
ratified 2019 regulations of the USM & PMHS, Guru Gobind Singh Indraprastha University,
and found the Introduction, Review of Literature, Lacunae in existing knowledge, Research
Question and hypothesis, Aims and Objectives, Material and Methods, Statistical Methods,
References and Appendices to be suitably drawn and based on sound scientific and ethical
foundation.

The Institutional Review Board confirms that the supervisor and co-supervisors of the study
meet the formally ratified 2019 regulations of the USM & PMHS, Guru Gobind Singh
Indraprastha University, and that neither the supervisor nor co-supervisors are part of thesis
projects that permitted them to them.

The Institutional Review Board/Thesis Protocol Review Committee meeting was chaired by
__________________________________and the following members of the committee were
present during the meeting:
1.
2.
3.
4.
5.
6.
The Institutional Review Board/Thesis Protocol Review Committee approved the study to be
conducted in the present form at VMMC and Safdarjung Hospital, New Delhi.

Signed by the Chairman,

The Institutional Review Board
Thesis Protocol Review Committee

Signature of the Dean/Head of Institution

Name of the Dean/Head of Institution

ix
 CONTENTS

S. TOPIC PAGE
NO. NO.
1 INTRODUCTION 1-2
2 REVIEW OF LITERATURE 3-5
3 LACUNAE IN EXISTING KNOWLEDGE 6
4 RESEARCH QUESTION 7
5 HYPOTHESIS 7
6 AIM AND OBJECTIVES 8
7 MATERIAL & METHODOLOGY 9-15
8 STATISTICAL ANALYSIS 16
9 REFERENCES 17-18
10 ANNEXURE I - HISTORY-TAKING AND EXAMINATION 19-20
FORM
11 ANNEXURE II - LYSHOLM KNEE SCORING SCALE 21-23
12 ANNEXURE III - VISUAL ANALOG SCALE (VAS) 24
13 ANNEXURE IV - INTERNATIONAL KNEE DOCUMENTATION 25-27
COMMITTEE (IKDC) QUESTIONNAIRE
14 ANNEXURE V - TAMPA SCALE FOR KINESIO PHOBIA 28-29
15 ANNEXURE VI - THIGH GIRTH 30
16 ANNEXURE VII - ANTI-GRAVITY TREADMILL PROTOCOL & 31-34
TRADITIONAL REHABILITATION
17 PARTICIPANT INFORMATION SHEET (PIS) (English/ Hindi) 35-36
18 INFORMED CONSENT FORM (English/ Hindi) 37-38
19 CHECKLIST 39-43

x
 ABBREVIATIONS

ACL – Anterior cruciate ligament

LCL – Lateral collateral ligament

MCL – Medial collateral ligament

PCL – Posterior cruciate ligament

RTS – Return to sports

IKDC – International Knee Documentation Committee

VAS – Visual Analogue Scale for pain

ROM – Range of Motion

xi
 INTRODUCTION

The knee joint is a biomechanically complex structure that is pivotal in human locomotion

and athletic performance. Despite its structural strength, it is particularly vulnerable to

injuries, especially anterior cruciate ligament (ACL) tears, which are among the most

prevalent sportsrelated injuries requiring surgical intervention and structured rehabilitation.

The anterior cruciate ligament contributes to the knee's anteroposterior and rotational

stability, particularly during high-demand activities involving pivoting, cutting, and sudden

deceleration.

Anterior cruciate ligament injuries disproportionately affect athletes engaged in sports like

football, basketball, and skiing. Female athletes have a 2-8 times higher risk than males,

attributed to anatomical and neuromuscular differences. Standard management typically

involves anterior cruciate ligament reconstruction followed by a progressive rehabilitation

protocol focusing on range of motion (ROM), muscle strengthening, proprioception, and

returnto-sport conditioning.

Structures that stabilize the knee joint include Joint capsule, Articular cartilage, Iliotibial

band, Anterior cruciate ligament (ACL), Lateral collateral ligament (LCL), Medial collateral

ligament (MCL), Posterior cruciate ligament (PCL), Menisci, Hamstring muscles, Quadriceps

muscles, Quadriceps tendon and patellar ligament and Reticular tissue.

Emerging rehabilitation modalities include the anti-gravity treadmill (AGT), which offers

partial body-weight support using differential air pressure technology. This allows earlier gait

training with reduced joint load, pain, and psychological fear of reinjury. Research has

demonstrated that anti-gravity treadmill improves gait symmetry, reduces joint stress, and

accelerates functional milestones in early postoperative anterior cruciate ligament

rehabilitation.

1
Conventional rehabilitation typically focuses on progressive weight-bearing, range of motion

(ROM), muscle strengthening, proprioception, and gradual return to sport. However, early

ambulation and full loading can pose graft strain or reinjury risks, particularly in the early

postoperative period.

The antigravity treadmill (anti-gravity treadmill), developed using NASA’s lower-body

positive pressure technology, offers partial body-weight support and allows for earlier and

safer mobilization. It reduces ground reaction forces and joint loading while maintaining

natural gait mechanics. Several studies have demonstrated the anti-gravity treadmill’s

potential benefits in anterior cruciate ligament rehabilitation, including improved gait

symmetry, reduced joint pain, faster return to weight-bearing, and enhanced patient

confidence.

Comparative analyses suggest that the anti-gravity treadmill may offer superior short-term

outcomes in terms of pain reduction, functional recovery, and psychological readiness.

Despite these advantages, challenges such as equipment cost, limited access, and inconsistent

rehabilitation protocols remain. There is also a paucity of large-scale randomized controlled

trials comparing anti-gravity treadmill with traditional rehabilitation in the case of anterior

cruciate ligament reconstruction. The scarcity of literature supports the feasibility and

shortterm benefits of anti-gravity treadmill in anterior cruciate ligament rehabilitation.

This study aims to evaluate and compare the functional outcomes, muscle strength, pain, and

return-to-activity timelines in patients undergoing anterior cruciate ligament reconstruction,

rehabilitated using antigravity treadmill protocols and traditional rehabilitation.

2
 REVIEW OF LITERATURE

Anterior cruciate ligament (anterior cruciate ligament) injuries are among the most prevalent

and debilitating sports-related injuries, particularly affecting athletes in pivot-heavy sports

such as football, basketball, and skiing. According to Evans et al. (2025), the anterior cruciate

ligament is essential for both anteroposterior and rotational stability of the knee, and its injury

significantly impairs functional mobility1. Studies also emphasize a notable sex disparity,

with female athletes demonstrating a 2–8 times higher risk due to a combination of

anatomical, hormonal, and neuromuscular factors (Mancino et al., 2024).2

Traditional rehabilitation following anterior cruciate ligament reconstruction emphasizes a

phased approach focusing on range of motion (ROM), muscle strength, proprioception, and

sport-specific reconditioning. Land-based rehabilitation progresses from non-weight bearing

to full weight-bearing activities, with the aim of gradually restoring knee function. While this

protocol is well-established, concerns remain regarding early weight-bearing, which can

result in femoral tunnel widening or graft stress, potentially compromising surgical outcomes

(Tajima et al., 2019).3

Patient-reported outcome measures such as the International Knee Documentation Committee

(IKDC) score are widely used, though debate continues about their structural validity.

Williams et al. (2020) confirmed a two-factor model—symptom and knee articulation, and

activity level—as superior to the original one-factor model. They also found that pre-

operative activity level predicted long-term quality of life, while post-operative symptoms

were more impactful.4

The antigravity treadmill (anti-gravity treadmill), based on NASA’s lower-body positive

pressure (LBPP) technology, has emerged as a novel adjunct in orthopedic and neurological

3
rehabilitation. By offloading body weight through differential air pressure, the anti-gravity

treadmill enables earlier and safer mobilization while preserving normal gait kinematics.

Kawae et al. (2017) demonstrated that anti-gravity treadmills facilitate aerobic activity with

reduced joint stress, showing promise in populations with lower limb joint pathologies.5

Similarly, Emoto & Sueyoshi (2018) noted improvements in balance and gait stability during

early postoperative rehabilitation using anti-gravity treadmill.6

Several small-scale clinical studies suggest that anti-gravity treadmills may accelerate early

functional recovery after anterior cruciate ligament reconstruction. Vincent et al. (2022)

found that anti-gravity treadmill training reduced joint pain and promoted confidence in early

mobilization, potentially addressing psychological barriers to rehabilitation, such as

kinesiophobia7. Additionally, Stockland et al. (2019) observed improved running cadence and

gait symmetry in anti-gravity treadmill users compared to conventional treadmill use8.

Willy and Davis (2011) highlighted that AGT allows safe, graded return to running by

controlling load percentages. Their findings are particularly relevant to ACL rehab, where

gradual reintroduction to dynamic activity is critical.9

Figueroa et al. (2018) compared functional outcomes in athletes undergoing AGT-based

rehab versus traditional programs following ACL reconstruction. The AGT group

demonstrated better balance control, reduced pain scores, and higher subjective knee scores at

12 weeks.10

Despite these findings, systematic reviews highlight the limited availability of high-quality

randomized controlled trials directly comparing anti-gravity treadmill with land-based

therapy in anterior cruciate ligament populations (Bonanno et al., 2024).11 Moreover,

accessibility and cost remain key barriers to widespread implementation, limiting the

generalizability of findings beyond specialized centers.

4
The scarcity of literature supports the feasibility and short-term benefits of anti-gravity

treadmill in anterior cruciate ligament rehabilitation. However, short term effectiveness

studies— particularly those evaluating muscle strength recovery, time to sport re-entry,

patient-reported outcomes, and reinjury rates—are scarce. Variations in rehabilitation

protocols, duration, and patient characteristics further complicate direct comparisons between

modalities.

5
 LACUNAE IN EXISTING KNOWLEDGE

There is a paucity of literature directly comparing functional outcomes between the anti-

gravity treadmill and traditional rehabilitation in patients with ACL reconstructed knees.

6
 RESEARCH QUESTION

Is there a difference in rehabilitation using an antigravity treadmill leading to functional

outcomes compared to traditional rehabilitation methods in patients following anterior

cruciate ligament reconstruction?

HYPOTHESIS

There is a difference in functional outcomes between patients undergoing antigravity

treadmill rehabilitation and those undergoing traditional rehabilitation after anterior cruciate

ligament reconstruction.

7
 AIM

To compare the effectiveness of antigravity treadmill rehabilitation and traditional

rehabilitation in improving functional outcomes, muscle strength and pain levels in patients

following anterior cruciate ligament reconstruction (ACLR).

OBJECTIVE

PRIMARY OBJECTIVE

To evaluate and compare clinically the effectiveness and functional outcomes of antigravity

treadmill in the rehabilitation protocol and compare it with traditional rehabilitation following

anterior cruciate ligament reconstruction (ACLR) on the knee joint function using IKDC

score and Lysholm score

SECONDARY OBJECTIVE

1. Assessment of pain using VAS SCORE

2. Assessment of fear and instability using TAMPA scale of Kinesio phobia

3. To analyze the difference in muscle strength by using a dynamometer

8
 MATERIAL & METHODOLOGY

Venue of study: Sports Injury Centre, VMMC and Safdarjung Hospital, New Delhi

Study Type: Prospective Randomized Control Trial

Study Duration: 18 months

Number of patients: 70 (35 in each group)

Study population: Subjects will be recruited from the Orthopedic OPD or Sports Injury

Centre, who are planned for arthroscopic anterior cruciate ligament surgery.

SAMPLE SIZE CALCULATION

The sample size for this study was calculated based on data from the study by Brown J. et al.

(2014) titled ―Traditional Rehabilitation versus Alter G Anti-Gravity Treadmill® Following

Anterior Cruciate Ligament Reconstruction: Clinical Outcomes from a Randomized

Controlled Study‖.12 The Lysholm score was selected as the primary outcome measure, and

its mean and standard deviation were used for the calculation.

Formula used for calculation:

n = [2 × (Zα + Zβ) ² × σ²] / (MA - MB) ²

Where:

- Zα = 1.96 (for 95% confidence level)

- Zβ = 0.84 (for 80% power)

- σ = Pooled Standard Deviation = 16.785

- MA = Mean of Group A (Anti-Gravity Treadmill) = 32

- MB = Mean of Group B (Traditional Rehabilitation) = 52.83

- d = (MB - MA) = 20.83

9
Calculation:

n = [2 × (1.96 + 0.84) ² × (16.785) ²] / (20.83)²

= [2 × (2.8) ² × 281.61] /

433.83 = [2 × 7.84 × 281.61]

/ 433.83

≈ 11 participants per group

To ensure robust statistical power and to compensate for potential dropouts (estimated at 10–

15%), the sample size was inflated to 35 participants per group.

Final Sample Size:

- Group A: 35 participants (Anti-Gravity Treadmill Rehabilitation)

- Group B: 35 participants (Traditional Rehabilitation)

Total sample size: 70 participants

Inclusion Criteria:

1. Isolated anterior cruciate ligament reconstructed patients aged 18 to 50 years, after 2

weeks of surgery.

2. Patients with no multi-ligamentous injuries (i.e., isolated anterior cruciate ligament

tears).

Exclusion Criteria:

1. Patients with meniscal injuries requiring delayed weight-bearing protocols.

2. Presence of neuromuscular disorders, balance impairments, or uncontrolled systemic

diseases (e.g., diabetes, hypertension).

3. Patients with lower limb fractures or recent surgeries other than anterior cruciate

ligament reconstruction.
10
 4. History of other pre-existing knee pathology, osteoarthritis, or prior knee surgeries.

5. Patients who are unable to comply with the rehabilitation protocol due to distance,

time, or personal reasons.

6. Pregnant women or individuals with contraindications to treadmill use (e.g.,

cardiovascular instability

Study Design:

Written informed consent from the patient will be taken prior to the conduct of the study.

Ethical clearance will be obtained from the Institutional Review Board before beginning

work on this thesis.

The study will be conducted according to the consolidated flow diagram. It is described

briefly below this diagram.

11
DETAILED FLOW CHART

12
1. Recruitment and Consent:

 Patients fulfilling inclusion and exclusion criteria will be identified from the Orthopaedic

OPD or the Sports Injury Centre.

 Written informed consent will be obtained from all participants before enrolment.

2. Randomization:

Subjects will be randomized using a computer-generated random sequence allocation

Group A: Antigravity Treadmill Rehabilitation Group.

Group B: Traditional Rehabilitation Group.

3. Baseline Assessment:

All patients will undergo pre-intervention evaluation, including:

International Knee Documentation Committee (IKDC) Score

• Lysholm Knee Score

• Visual Analogue Scale (VAS) for pain

• Range of Motion (ROM) using a goniometer

• Thigh Girth Measurement at 5 cm, 10 cm, and 15 cm above the superior pole

of the patella

• Tampa scale of Kinesio phobia.

4. Intervention Phase:
After 2 weeks, patients will begin their allocated rehabilitation protocol:

Group A (Anti-Gravity Treadmill): Rehabilitation sessions using an anti-gravity treadmill,

progressing as per the structured program (ANNEXURE: Anti-Gravity Treadmill Protocol). -

13
Group B (Traditional Rehabilitation): Conventional land-based rehabilitation following

standard protocols (ANNEXURE: Traditional Rehab Protocol).

5. Evaluation:
Assessments will be performed at baseline (pre-rehabilitation), 2 weeks, 1 Month and 3

Months post-operatively using the following outcome measures:

 Functional Assessment: Lysholm Score, IKDC Score.

 Pain Assessment: Visual Analog Scale (VAS).

 Muscle Strength: 1 Repetition Maximum (1RM) testing, biofeedback via DAVID system.

 Psychological Readiness: Tampa Scale of Kinesio phobia (TSK-13).

 Anthropometric Measures: Thigh and calf girth measurements.

6. Data Collection:

Data will be collected using a pre-designed proforma (see ANNEXURE). All assessments

will be performed by trained professionals blinded to group allocation to minimize bias.

7. Follow-Up:

Regular follow-ups will ensure adherence to rehabilitation and monitor for any adverse

effects. Any deviations or complications will be documented and managed as per institutional

protocols.

14
Outcome Measures:

1. Functional Outcome

Assessed using Lysholm Knee Scoring Scale and IKDC Subjective Knee Form at

baseline, 2 weeks, 1 Month, and 3 Months

2. Pain Intensity

Assessed using the visual Analog scale (VAS), scored from 0(No Pain) to 10(Worst

imaginable Pain) at baseline, 2 weeks, 1 Month, and 3 Months

3. Muscle Strength

Measured using a standardised dynamometer at baseline, 2 weeks, 1 Month, and 3

Months

4. Fear of Movement

Assessed using the Tampa Scale of Kinesio phobia at baseline, 2 weeks, 1 Month, and

3 Months

15
 STATISTICAL ANALYSIS

SOFTWARE SELECTION

Statistical analysis will be performed using the latest available version of IBM SPSS

STATISTICAL TESTS

Quantitative data will be expressed as frequency and percentage and quantitative data will be

presented in mean, median, range (min-max) and mean ± standard deviation (SD), variance.

The t-test or ANOVA will be used to compare quantitative variables among different groups.

The chi-square (χ2) test will be used to assess the relationship between two categorical

variables. The confidence interval is considered to be 95%. A p-value of <0.05 will be

considered statistically significant. Other suitable and relevant statistical tests will be applied.

16
 REFERENCES

1. Evans J, Mabrouk A, Nielson Jl. Anterior Cruciate Ligament Knee Injury. [Updated

2023 Nov 17]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing;

2025.

2. Mancino F, Kayani B, Gabr A, Fontalis A, Plastow R,Haddad FS. Anterior cruciate

ligament injuries in female athletes: risk factors and strategies for prevention. Bone

JtOpen. 2024;5(2):94–100.

3. Tajima T, Yamaguchi N, Nagasawa M, Morita Y, Nakamura Y, Chosa E. Early

weightbearing after anterior cruciate ligament reconstruction with hamstring grafts

induces femoral bone tunnel enlargement: a prospective clinical and radiographic study.

BMC Musculoskelet Disord. 2019;20(1):274.

4. Hauser RA, Steilen-Matias D, Lackner JB, Rawlings BR, Mann J, Grogan T, et al.

Ligamentous knee joint instability: Association with chronic conditions of the knee and

treatment with prolotherapy. Open Pain J. 2023 Nov 16.p.1-25

5. Kawae T, Mikami Y, Fukuhara K, Kimura H, Adachi N. Anti-gravity treadmill can

promote aerobic exercise for lower limb osteoarthritis patients. J Phys Ther

Sci.2017;29(8):1444–8.

6. Emoto G, Sueyoshi T. The effect of anti-gravity treadmill on balance in the acute phase

of post-operative knee rehabilitation. Asian J Sports Med. 2018;9(4).

7. Vincent HK, Madsen A, Vincent KR. Role of antigravity training in rehabilitation and

return to sport after running injuries. Arthrosc Sports Med Rehabil. 2022;4(1):141–9.

8. Stockland J, Russell Giveans M, Ames P. The effect of ananti-gravity treadmill on

running Cadence. Int J Sports Phys Ther. 2019;14(6):860–5.

9. Willy RW, Davis IS. The effect of a hip-strengthening program on mechanics during

running and during a single-leg squat. J Orthop Sports Phys Ther. 2011;41(9):625–32.

17
10. Figueroa F, Figueroa D, Espregueira-Mendes J. Hamstring autograft size importance in

anterior cruciate ligament repair surgery. EFORT Open Rev. (2018) Apr;3(4):93–97.

11. Bonanno M, Maggio MG, Quartarone A, De Nunzio AM, Calabrò RS. Simulating space

walking: a systematic review on anti-gravity technology in neurorehabilitation. J

Neuroeng Rehabil. 2024;21(1):159.

12. Brown J, Larsen B, Jacofsky MC, Neal D, Brooks K. Traditional Rehabilitation versus

AlterG Anti-Gravity Treadmill® Following Anterior Cruciate Ligament Reconstruction:

Clinical Outcomes from a Randomized Controlled Study. Sun City West (AZ): The

CORE Institute; SHRI-CORE Orthopedic Research; 2014. Report No.: 141204 ACLS

Rev. A.

13. Lysholm, J., Tegner, Y. Knee injury rating scales. Acta Orthop. 2007; 78: 445–453

14. Irrgang JJ, Anderson AF, Boland AL, Harner CD, Kurosaka M, Neyret P, Richmond JC,

Shelbourne KD. Development and validation of the International Knee Documentation

Committee subjective knee form. Am J Sports Med. 2001 Sep-Oct;29(5):600-13

15. Vlaeyen, J. W., Kole-Snijders, A. M., Boeren, R. G., & van Eek, H. (1995). Fear of

movement/(re)injury in chronic low back pain and its relation to behavioral

performance. Pain, 62(3), 363–372.

18
 APPENDIX 1

HISTORY-TAKING AND EXAMINATION FORM

Patient’s name: Date of examination:

Age: Sex:

Address:

Phone no.:

Examined by:

Brief history:

No. of instability episodes:

H/O locking after injury:

Previous history of surgery on same knee:

Previous history of pain/ click/ locking in same knee before injury:

Clinical examination findings:

a) Range of motion index side- passive: active: opposite side-

passive: active:

b) Lachman test:

c) Anterior drawer test:

d) Pivot shift test:

19
 e) Mc Murray’s test:

f) Posterior drawer test:

g) Varus stress test

h) Valgus stress test

Baseline 2 Weeks 1 Month 3 Months

LYSHOLM13

IKDC

VAS

Tampa scale of
Kinesio phobia

20
 ANNEXURE II
LYSHOLM KNEE SCORING SCALE13

Instructions: Below are common complaints that people frequently have with their knee
problems. Please check the statement that best describes your condition.

I. LIMP:

I have no limp when I walk. (5)

I have a slight or periodical limp when I walk. (3)

I have a severe and constant limp when I walk. (0)

II. USING CANE OR CRUTCHES

I do not use a cane or crutches. (5)

I use a cane or crutches with some weight-bearing. (2)

Putting weight on my hurt leg is impossible. (0)

III. LOCKING SENSATION IN THE KNEE

I have no locking and no catching sensations in my knee. (15)

I have a catching sensation but no locking sensation in my knee. (10)

My knee locks occasionally. (6)

My knee locks frequently. (2)

My knee feels locked at this moment. (0)

IV. GIVING WAY SENSATION FROM THE KNEE

My knee never gives way. (25)

My knee rarely gives way, only during athletics or other vigorous activities. (20)

21
 My knee frequently gives way during athletics or other vigorous activities; in turn, I am
unable to participate in these activities. (15)

My knee occasionally gives way during daily activities. (10)

My knee often gives way during daily activities. (5)

My knee gives way every step I take. (0)

V. PAIN:

I have no pain in my knee. (25)

I have intermittent or slight pain in my knee during vigorous activities. (20)

I have marked pain in my knee during vigorous activities. (15)

I have marked pain in my knee during or after walking more than 1 mile. (10)

I have marked pain in my knee during or after walking less than 1 mile. (5)

I have constant pain in my knee. (0)

VI. SWELLING

I have no swelling in my knee. (10)

I have swelling in my knee only after vigorous activities. (6)

I have swelling in my knee after ordinary activities. (2)

I have swelling constantly in my knee. (0)

VII. CLIMBING STAIRS:

I have no problems climbing stairs. (10)

I have slight problems climbing stairs. (6)

22
I can climb stairs only one at a time. (2)

Climbing stairs is impossible for me. (0)

VIII. SQUATTING

I have no problems squatting. (5)

I have slight problems squatting. (4)

I cannot squat beyond a 90-degree bend in my knee. (2)

Squatting is impossible because of my knee. (0)

TOTAL /100

23
 ANNEXURE - III

VISUAL ANALOG SCALE (VAS)

How severe is your pain today? Place a vertical mark on the line below to indicate how bad

your pain is today.

24
 ANNEXURE – IV

INTERNATIONAL KNEE DOCUMENTATION COMMITTEE (IKDC) QUESTIONNAIRE14

SYMPTOMS:

Grade symptoms at the highest activity level at which you think you could function without significant
symptoms, even if you are not performing activities at this level.

1. What is the highest level of activity that you can perform without significant knee pain?

• [ ] Very strenuous activities like jumping or pivoting, as in basketball or soccer

• [ ] Strenuous activities like heavy physical work, skiing, or tennis

• [ ] Moderate activities like moderate physical work, running, or jogging

• [ ] Light activities like walking, housework, or yard work

• [ ] Unable to perform any of the above activities due to knee pain

2. During the past 4 weeks, or since your injury, how often have you had pain?

Never 0 [ ] 1 [ ] 2 [ ] 3 [ ] 4 [ ] 5 [ ] 6 [ ] 7 [ ] 8 [ ] 9 [ ] 10 [ ] Constant

3. If you have pain, how severe is it?

No pain 0 [ ] 1 [ ] 2 [ ] 3 [ ] 4 [ ] 5 [ ] 6 [ ] 7 [ ] 8 [ ] 9 [ ] 10 [ ] Worst pain imaginable

4. During the past 4 weeks, or since your injury, how stiff or swollen was your knee?

• [ ] Not at all

• [ ] Mildly

• [ ] Moderately

• [ ] Very

• [ ] Extremely

5. What is the highest level of activity you can perform without significant swelling in your
knee?

• [ ] Very strenuous activities like jumping or pivoting as in basketball or soccer

• [ ] Strenuous activities like heavy physical work, skiing or tennis

• [ ] Moderate activities like moderate physical work, running or jogging

• [ ] Light activities like walking, housework or yard work

• [ ] Unable to perform any of the above activities due to knee swelling

6. During the past 4 weeks, or since your injury, did your knee lock or catch?

25
 • [ ] Yes

• [ ] No

7. What is the highest level of activity you can perform without significant giving way in
your knee?

• [ ] Very strenuous activities like jumping or pivoting as in basketball or soccer

• [ ] Strenuous activities like heavy physical work, skiing or tennis

• [ ] Moderate activities like moderate physical work, running or jogging

• [ ] Light activities like walking, housework or yard work

• [ ] Unable to perform any of the above activities due to giving way of the knee

SPORTS ACTIVITIES:

8. What is the highest level of activity you can participate in on a regular basis?

• [ ] Very strenuous activities like jumping or pivoting as in basketball or soccer

• [ ] Strenuous activities like heavy physical work, skiing or tennis

• [ ] Moderate activities like moderate physical work, running or jogging

• [ ] Light activities like walking, housework or yard work • [ ] Unable to

perform any of the above activities due to knee

9. How does your knee affect your ability to:

Activity Not difficult Minimally Moderately Extremely Unable to
at all difficult difficult difficult do

a. Go upstairs [] [] [] [] []

b. Go downstairs [] [] [] [] []

c. Kneel on the front of [ ] [] [] [] []

your knee

d. Squat [] [] [] [] []

e. Sit with your knee [] [] [] [] []

bent

f. Rise from a chair [] [] [] [] []

g. Run straight ahead [] [] [] [] []

26
 [] [] [] [] []
h. Jump and land on

Activity Not difficult Minimally Moderately Extremely Unable to

at all difficult difficult difficult do

your involved leg

Stop and start quickly [] [] [] [] []

FUNCTION:

10. How would you rate the function of your knee on a scale of 0 to 10, with 10 being
normal, excellent function, and 0 being the inability to perform any of your usual daily
activities, which may include sports?

FUNCTION PRIOR TO YOUR KNEE INJURY:

Cannot perform daily activities 0 [ ] 1 [ ] 2 [ ] 3 [ ] 4 [ ] 5 [ ] 6 [ ] 7 [ ] 8 [ ] 9 [ ] 10 [ ] No limitation in

daily activities

CURRENT FUNCTION OF YOUR KNEE:

Cannot perform daily activities 0 [ ] 1 [ ] 2 [ ] 3 [ ] 4 [ ] 5 [ ] 6 [ ] 7 [ ] 8 [ ] 9 [ ] 10 [ ] No limitation in

daily activities

27
 ANNEXURE V
TAMPA SCALE FOR KINESIO PHOBIA15

(Miller, Kori, and Todd 1991)

A total score is calculated after inversion of the individual scores of items 4, 8, 12 and
16. 1 = strongly disagree
2 = disagree
3 = agree
4 = strongly agree

1. I’m afraid that I might injury myself if I exercise 1 2 3 4

2. If I were to try to overcome it, my pain would increase 1 2 3 4

3. My body is telling me I have something dangerously 1 2 3 4

wrong
4. My pain would probably be relieved if I were to 1 2 3 4
exercise
5. People aren’t taking my medical condition seriously 1 2 3 4
enough
6. My accident has put my body at risk for the rest of 1 2 3 4
my life
7. Pain always means I have injured my body 1 2 3 4
8. Just because something aggravates my pain does not 1 2 3 4
mean it is dangerous

9. I am afraid that I might injure myself accidentally 1 2 3 4

10. Simply being careful that I do not make any 1 2 3 4

unnecessary movements is the safest thing I can do to
prevent my pain from worsening
11. I wouldn’t have this much pain if there weren’t 1 2 3 4
something potentially dangerous going on in my body

12. Although my condition is painful, I would be better 1 2 3 4

off if I were physically active
13. Pain lets me know when to stop exercising so that I 1 2 3 4
don’t injure myself
14. It’s really not safe for a person with a condition like 1 2 3 4
mine to be physically active
15. I can’t do all the things normal people do because it’s 1 2 3 4
too easy for me to get injured

28
16. Even though something is causing me a lot of pain, I 1 2 3 4
don’t think it’s actually dangerous
17. No one should have to exercise when he/she is in pain 1 2 3 4

29
 ANNEXURE V1

THIGH GIRTH: -

To measure thigh girth, use the greater trochanter and superior pole of the patella as landmarks. The

standard point is the mid-thigh. Alternatively, fixed distances above the patella, 15 cm from the

superior pole of the patella. With the person standing or lying with muscles relaxed, wrap a non-

stretch tape measure around the circumference without compressing the tissue. Ensure the tape is level

and snug but not tight.

CALF GIRTH: -

The broadest portion of the calf, or a standard distance from landmarks such as the lateral malleolus

or tibial tuberosity, is the usual place to measure calf girth. Usually, it is utilized 15–20 cm above the

malleolus or below the tibial tuberosity. The leg should be relaxed as the person stands or lies down.

30
 ANNEXURE V11

Group A (anti-gravity treadmill

Group): o
Week Exercise Dose Purpose Notes /
Progression
2 weeks Antigravity 10–15 mins × 2 Gait reeducation, Focus on heeltoe
walking (50% sets reduce joint gait; increase
body weight loading time before
support, 2–3 speed
km/h)
3–4 Static Marching 10–12 reps/leg × Quad and hip Begin without
(in treadmill 2 sets flexor activation incline; ensure
chamber) no extension lag
4-5 Mini Squats (0– 10–12 reps × 2 Initial quad/glute Ensure
30°) while sets activation symmetrical
supported loading
5–6 Antigravity 30 sec jog + 30 Begin Short stride jogs,
treadmill jog sec walk x 10 neuromuscular monitor VAS
(40–60% body reps jogging pain scale
weight support) (<2/10)
5–6 Forward and 10 mins × 2 sets Coordination, Progress to
Lateral Walking proprioception increased
(with incline 1– incline/speed
2%)
5–6 Standing 10–15 reps × 2 Hamstring Avoid resistance
Hamstring Curls sets recruitment initially
(with support)

7–8 Jogging (60– 1 min jog + 1 Cardiovascular Increase %BW

80% BW min walk × 8–10 endurance, quad only if pain-free
support at 4–5 reps loading
km/h)
7–8 Reverse Walking 10–15 mins × 2 Posterior chain & Encourage knee
sets knee stability control, monitor
form
7–8 Side Stepping 10 steps each Hip abductors, Progress to
(slow) side × 2 sets balance dynamic
direction change
9–10 Progressive 2–3 min jog × 3 Pre-return to Ensure full
Jogging (80– sets land-based ROM, no
100% BW at 6– jogging effusion
7 km/h)
9–10 Carioca 10 steps × 2 sets Coordination, Start with low
(grapevine-style) lateral control pace, maintain
movement drills core control

31
9–10 High-Knee 30 sec × 2–3 sets Plyometric prep, No excessive
Skipping (with hip flexor impact, monitor
support if activation knee alignment
needed)
11–12 Continuous 10 mins × 3 sets Functional Full
Jogging (100% jogging, return to weightbearing
BW, 7–8 km/h) run readiness without
symptoms
11–12 Single-Leg Drills 8–10 reps each × Unilateral Start supported;
(step-over jogs, 2 sets control, progress to
lateral hops) proprioception dynamic drills

11–12 Sprint Intervals 30 sec sprint × 4 End-stage Only after

(optional, under sets athletic return clearance and
supervision) full strength
symmetry

GROUP B -TRADITIONAL REHABILITATION

Standard Rehabilitation (0-2 weeks post-op)

Goals:
1. Decrease pain
2. Decrease swelling
3. Protect repair
4. Regain range of motion
5. Muscle activation
6. Mobilization

Week Goals Exercise / Intervention Dose Frequency Intensity / Notes

0–1 Pain, Rest, Ice, 15–20 mins 3–5×/day Ice after exercises;
swelling, Compression, per session elevate the leg
and Elevation above the heart
protection

Ankle Pumps 20–30 reps Every hour Low intensity,

keeps blood
flowing

32
 Quad Sets (Isometric) 5–10 sec 3–4×/day Submaximal
hold × 10 contraction of
reps quads; Target to
reach 45 secs hold
x 5 reps with 2
mins rest in
between each
repetition
Patellar Mobilizations 30–60 sec 2–3×/day Mild pressure,
pain-free

Heel Prop / Extension Hold 5–10 3–5×/day Passive stretch for

Stretch mins full extension

1–2 ROM, Heel Slides 10–15 reps 3–4×/day Within pain-free

muscle (ActiveAssisted) range (goal: ~90°
activation flexion)

Straight Leg Raise 10 reps × 3 2–3×/day No lag; use a brace

sets if needed

Seated Knee 10–15 reps 2–3×/day Stay within 0–90°

Flexion/Extension ROM
(gravity-assisted)

Gait Training (with 10–15 min 2×/day Heel-to-toe

assistive device) walks walking pattern

5–10 mins, 1×/day ROM goal only, not

Stationary Bike no resistance cardio
(if ROM ≥ 100°) -
Rocking movement

2–3 ROM, Mini Squats (0–30°) 10 reps × 2– 1–2×/day Controlled, no

strength, 3 sets valgus knee motion
mobility

33
Side-Lying Hip 10 reps × 2 1–2×/day Focus on glute
Abduction sets Medius, avoid
trunk roll

Standing Hamstring 10–15 reps 2×/day Controlled, no

Curls (gravity only) added weight

Stationary Bike 10–15 mins 1–2×/day Low resistance,

smooth ROM

34
 PARTICIPANT INFORMATION SHEET (PIS)

Dear Participant,

We are conducting a study in our hospital titled ―COMPARISON OF EFFECTIVENESS

OF FUNCTIONAL OUTCOME OF ANTI-GRAVITY TREADMILL
REHABILITATION AND TRADITIONAL REHABILITATION IN ANTERIOR
CRUCIATE LIGAMENT RECONSTRUCTED PATIENTS.”

All the patients in this study will be divided into two groups, one where you will be given

antigravity treadmill rehabilitation along with traditional rehabilitation, and the other where

only traditional rehabilitation will be done.

We will then evaluate your functional outcomes using various scores at 2 weeks, 1 month,

and 3 months. We are doing this study to determine the advantage of antigravity treadmill

rehabilitation and to evaluate its beneficial effects in anterior cruciate ligament reconstruction

surgery. If proven to be beneficial, the study will help in better healing and faster recovery for

patients with anterior cruciate ligament reconstruction.

The procedure is overall safe. Some minor side effects include pain, inflammation, which will

be managed accordingly.

Principal Investigator: Dr ANJU SINGAL

Supervisor: Dr PALLAV MISHRA

Phone no.: +91 7015628257

Phone no.: +919310787120

35
 प्रतिभागी सूचना पत्रक (पीआईएस)
प्रिय िप्रिभागी,

हम अपने अस्पिाल में एक अध्ययन कर रहे हैं प्रजसका शीर्षक है “एं टी-ग्रेतिटी टर े डतिल पुनिाास
और एं टीररयर क्रूतसएट तलगािेंट पुनतनािााण रोतगयों िें पारं पररक पुनिाास के कायाात्मक
पररणािों की प्रभािशीलिा की िुलना।”

इस अध्ययन में सभी रोप्रगयोों को दो समूहोों में प्रिभाप्रजि प्रकया जाएगा, एक जहााँ आपको पारों पररक
पुनिाष स के साथ-साथ एों टीग्रे प्रिटी टर े डप्रमल पुनिाष स प्रदया जाएगा, और दू सरा जहााँ केिल पारों पररक
पुनिाष स प्रकया जाएगा।

प्रिर हम 2 सप्ताह, 1 महीने और 3 महीने में प्रिप्रभन्न स्कोर का उपयोग करके आपके कायाष त्मक
पररणामोों का मूल्ाों कन करें गे। हम एों टीग्रेप्रिटी टर े डप्रमल पुनिाष स के लाभ को प्रनधाष ररि करने और
एों टीररयर क्रूप्रसएट प्रलगामेंट पुनप्रनषमाष ण सजषरी में इसके लाभकारी िभािोों का मूल्ाों कन करने के प्रलए
यह अध्ययन कर रहे हैं । यप्रद यह अध्ययन लाभकारी प्रसद्ध होिा है , िो यह पूिषििी क्रूप्रसएट प्रलगामेंट
पुनप्रनषमाष ण िाले रोप्रगयोों के प्रलए बेहिर उपचार और िेजी से ररकिरी में मदद करे गा।

यह िप्रक्रया कुल प्रमलाकर सुरप्रिि है । कुछ मामूली दु ष्प्रभािोों में ददष , सूजन शाप्रमल है , प्रजसे िदनुसार
िबोंप्रधि प्रकया जाएगा।

िमुख अन्वेर्क: डॉ अोंजू प्रसोंघल

पयषिेिक: डॉ पल्लि प्रमश्रा

फोन नोंबर: +91 7015628257

फोन नोंबर: +919310787120

36
 INFORMED CONSENT FORM

Patient’s identification number for this trial:_____________________________________

Title of project: ―COMPARISON OF EFFECTIVENESS OF FUNCTIONAL OUTCOME OF

ANTI-GRAVITY TREADMILL REHABILITATION AND TRADITIONAL
REHABILITATION IN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTED
PATIENTS
Name of Principal Investigator: Dr. Anju Singal Tel. No(s): +91-7015628257
The contents of the information sheet dated ………………… that was provided have been
read carefully by me / explained in detail to me, in a language that I comprehend, and I have
fully understood the contents. I confirm that I have had the opportunity to ask questions.

The nature and purpose of the study and its potential risks/benefits, and the expected duration
of the study, and other relevant details of the study have been explained to me in detail. I
understand that my participation is voluntary and that I am free to withdraw at any time,
without giving any reason, without my medical care or legal rights being affected.

I understand that the information collected about me from my participation in this research
and sections of any of my medical notes may be looked at by responsible individuals from
the Sports Injury Centre, Safdarjung Hospital. I permit these individuals to have access to my
records.
I agree to take part in the above study.

(Signature/ Left Thumb Impression) Date:

Name of the participant: __________________________ Place: __________________

Son/Daughter/Spouse of: __________________________ Complete postal address:
__________________________ __________________________ This is to certify that the
above consent has been obtained in my presence.

(Signature of Witness 1) (Signature of Witness 2)

Name of Witness 1: _________________ Name of Witness 2: _________________

(Signature of the Principal Investigator) (Signature of the Supervisor)
Dr Anju Singal, Dr Pallav Mishra (MS)
Date: _________________

37
 सूतचि सहिति प्रपत्र

इस परीिण के प्रलए रोगी की पहचान सोंख्या:_____________________________________

पररयोजना का शीर्षक: “एों टी-ग्रेप्रिटी टर े डप्रमल पुनिाष स और पूिषकाल क्रूप्रसएट प्रलगामेंट पुनप्रनषप्रमषि
रोप्रगयोों में पारों पररक पुनिाष स के कायाष त्मक पररणाम की िभािशीलिा की िुलना
िमुख अन्वेर्क का नाम: डॉ. अोंजू प्रसोंघल दू रभार् सोंख्या: +91-7015628257

प्रदनाों क …………………. को िदान की गई सूचना पत्र की सामग्री को मैंने ध्यान से पढा है /मुझे प्रिस्तार से

समझाया है , ऐसी भार्ा में प्रजसे मैं समझिा हाँ , और मैंने सामग्री को पूरी िरह से समझ प्रलया है । मैं पुप्रि
करिा हाँ प्रक मुझे िश्न पूछने का अिसर प्रमला है ।
अध्ययन की िकृप्रि और उद्दे श्य और इसके सोंभाप्रिि जोखखम/लाभ, और अध्ययन की अपेप्रिि अिप्रध,
और अध्ययन के अन्य िासोंप्रगक प्रििरण मुझे प्रिस्तार से समझाए गए हैं । मैं मैं समझिा हाँ प्रक मेरी
भागीदारी स्वैखिक है और मैं प्रकसी भी समय, प्रबना कोई कारण बिाए, प्रबना मेरी प्रचप्रकत्सा दे खभाल
या कानूनी अप्रधकारोों को िभाप्रिि प्रकए, िापस लेने के प्रलए स्विोंत्र हाँ ।
मैं समझिा हाँ प्रक इस शोध में मेरी भागीदारी से मेरे बारे में एकप्रत्रि की गई जानकारी और मेरे प्रकसी
भी मेप्रडकल नोट के अनुभागोों को स्पोटटष स इों जरी सेंटर, सिदरजोंग अस्पिाल के प्रजम्मेदार व्यखियोों
द्वारा दे खा जा सकिा है । मैं इन व्यखियोों को अपने ररकॉडष िक पहाँ च की अनुमप्रि दे िा हाँ ।
मैं उपरोि अध्ययन में भाग लेने के प्रलए सहमि हाँ ।
(हस्तािर/बाएाँ अोंगूठे का प्रनशान) प्रदनाों क:
िप्रिभागी का नाम: __________________________ स्थान: __________________ पुत्र/पुत्री/पप्रि/पत्नी:
__________________________ पूरा डाक पिा: __________________________
__________________________ यह िमाप्रणि प्रकया जािा है प्रक उपरोि सहमप्रि मेरी उपखस्थप्रि में िाप्त
की गई है ।

(गिाह 1 के हस्तािर) (गिाह 2 के हस्तािर)

गिाह 1 का नाम: _________________ गिाह 2 का नाम: _________________

(िधान अन्वेर्क के हस्तािर) (पयषिेिक के हस्तािर)

डॉ अोंजू प्रसोंघल, डॉ पल्लि प्रमश्रा (एमएस)

38
 University School of Medicine and Paramedical Health Sciences
Guru Gobind Singh Indraprastha University, New Delhi
Candidate’s Checklist
{to be filled and attached as a part of the thesis protocol}

Name: Dr. Anju Singal Course: MD SPORTS MEDICINE,

Institution: VMMC and SJH

TITLE OF THE THESIS PROTOCOL: COMPARISON OF EFFECTIVENESS OF

FUNCTIONAL OUTCOME OF ANTI-GRAVITY TREADMILL REHABILITATION
AND TRADITIONAL REHABILITATION IN ANTERIOR CRUCIATE LIGAMENT
RECONSTRUCTED PATIENTS

S. Checklist for Thesis Protocol Place (√)

No. or (×)

Title Page of the Protocol

1. Does the title reflect the aims and objective(s) of the proposal?
√

2. Does the title page include your name, course, batch year, college, √
university?

First Preliminary Page of the Protocol

3. Does the page carry your name and signature? √

4. Does the page carry the name, university designation and signature of √
your thesis supervisor?

5. Does the page carry the name, university designation and signature of the √
co-supervisor/s?

6. Does the page carry the name and signature of your Head of Department? √

7. Does the page carry the name and signature of your Head of Institution? √

Undertaking and Certificates

8. Have you attached the declaration (5.5.1) that the thesis protocol does not √
violate the copyright act in any way, is free of plagiarism, and you’ve not
reproduced any ―questionnaires‖, ―scores‖, diagrams, figures, tables,
flowcharts which may infringe the copyright act?

9. Have you attached your supervisor’s and co-supervisors’ certificate (5.5.2) √

that they would supervise and guide your work?

39
10. Have you attached certificate (5.5.3) bearing your own, your supervisor’s, √
your co-supervisors’ and Head of Department’s signatures asserting the
feasibility of the study; the study sample size having been calculated on
the basis of relatable statistical formula and satisfying the requirements of
study design and the proposed statistical analysis; the thesis plan not
being a repetition of a similar work undertaken in the previous 5 years;
the plan not entailing a retrospective collection or analyses of data from
old patient case records; not employing any ―off-label drug trial‖;
assertion that participants would not bear any financial burden on account
of the investigations, devices, implants or drugs employed; and that the
study would not require you to take any obligation from a pharmaceutical
company, device manufacturer or medical supplier?

11. Have you attached the certificates of your Institutional Review Board √
(IRB)/Thesis Protocol Review Board (5.5.4) and Institutional Ethics
Committee (IEC) (5.5.5) conveying their formal approval of the project in
the study protocol?

Table of Content

12. Have you drawn a table of contents and numbered all pages of the √
protocol in the following sequence: ¨Introduction; ¨Review of Literature;
¨Lacunae in existing knowledge; ¨Research question and Hypothesis;
¨Aims and Objectives; ¨Material and Methods; ¨Statistical methods;
¨References; ¨Appendices?

Introduction

13. Have you provided a brief description of the existing knowledge on your √
research topic under ―Introduction‖?

Review of Literature (ROL)

14. Have you exhaustively reviewed the current literature on the research √
topic and presented a comprehensive summary of the current knowledge
in a lucid manner under the Review of Literature?

Research Question and Hypothesis

15. Have you clearly stated the research question that you wish to resolve? √

16. Does the hypothesis match the research question and is it based on a sound √
scientific presumption?

Aims and Objectives

17. Have you clearly stated the Aims and Objectives of the study? √

18. Is the Aim in accordance with the research topic? √

19. Are the Primary Objectives clearly stated? √

20. Are the Secondary Objectives clearly stated? √

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21. Are the Objectives aligned with the research subject? √

22. Are the Objectives achievable in a specified time frame? √

23. Are the Objectives achievable within the existing resources? √

Materials and Methods

24. Have you stated the place of study? √

25. Have you stated the period of study? √

26. Have you stated the type of study you’re undertaking? √

27. Does the stated study type match with the research design? √

28. Is the study population defined? √

29. Is the method of recruitment defined? √

30. Are the inclusion criteria defined? √

31. Are the exclusion criteria defined? √

32. In studies where applicable, are the study groups defined? √

33. Do you intend to employ a control group? √

34. Is the control group suitably matched to the participants of the study? √

35. Is the study sample size calculated on the basis of a sound relatable √
statistical formula?

36. Does the study sample size match the study design and statistical methods √
you propose to employ on the data?

37. Have you included a detailed study flow chart in the protocol? √

38. Have you included the details of the proposed investigations and how they √
relate to your study?

39. Do you intend to carry out any interventions? √

40. Have you included the details of the proposed interventions? √

41. Do you have a gold standard to clinch the diagnosis? √

42. How accurate is the gold standard? √

43. Have you included the outcome measures? √

44. Have you included any ―clinical scores‖? √

45. If yes, are these ―clinical scores‖ copyright free? NA

41
46. If copyrighted, have you taken steps to ensure you do not violate the NA
copyright?

Statistical methods

47. Have you stated the statistical methods you would employ to gauze the √
obtained data?

48. Have you explained how the stated statistical methods would be employed √
to obtain results?

References

49. Have you numbered each reference beginning with page 1 of the √
introduction and till the end of the protocol in a continuous sequence in
order of their appearance (as is prescribed in Vancouver style)?

50. Have you cited the references as they appear within the text in Arabic √
numerals in superscript?

51. Under the references section, have you listed the details of each reference √
as prescribed in Vancouver style?

Appendix

52. Does the protocol carry any questionnaire? √

53. Is the questionnaire validated? √

54. Is the questionnaire copyright free? NA

55. Have you included a detailed study pro forma to capture all significant √
elements of the study?

Patient Information sheet (PIS)

56. Have you included PIS in Hindi? √

57. Have you included PIS in English? √

58. Does the PIS state the purpose of the study? √

59. Does it mention how it is going to benefit the participants? √

60. Does it state the procedures and tests to be done? √

61. Does it elaborate on how the procedures and tests will be done? √

62. Does it mention the potential side effects and/or risks? √

63. Does it include your and your supervisor’s name and contact number? √

64. Have you clearly stated any know ethical issue(s)? √

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 Informed Consent Form

65. Have you included an informed consent form in Hindi? √

66. Have you included an informed consent form in English? √

67. Does the informed consent form bear the name, address, contact number √
and signature of the participant?

68. Does the informed consent form bear the name, address, contact number √
and signature of a witness?

Binding

69. Is the thesis protocol firmly bound? √

Candidate’s Checklist

70. Have you submitted the filled-up Candidate’s Checklist in the bound √
thesis protocol?

SIGNATURE OF THE CANDIDATE (DR ANJU SINGAL)

SIGNATURE OF THE SUPERVISOR (DR PALLAV MISHRA)

43