| CTRI Number |
CTRI/2025/05/087921 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Is Supervised Rehab Better After ACL Surgery? A Pilot Study on Recovery Outcomes" |
|
Scientific Title of Study
|
Benefits of supervised over unsupervised rehabilitation program in unilateral ACL reconstruction patients: A Pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAKTHIMURUGAN R |
| Designation |
Sports medicine resident |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Sports Medicine
Building No 3 old command complex
Armed Forces Medical College
Pune
Pune
MAHARASHTRA
411036
India |
| Phone |
8667893630 |
| Fax |
|
| Email |
rsm1148@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hrishikesh Pande |
| Designation |
Professor, Head and guide |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Sports Medicine Armed Forces Medical college Solapur- Pune Highway Near race course Wanowarie
Pune
MAHARASHTRA
411036
India |
| Phone |
8698480587 |
| Fax |
|
| Email |
rsm1148@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAKTHIMURUGAN R |
| Designation |
Sports medicine resident |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Sports Medicine,
Solapur-Pune Highway Near race course road
Wanowarie
Pune
MAHARASHTRA
411036
India |
| Phone |
8667893630 |
| Fax |
|
| Email |
rsm1148@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College Southern command Solapur-Pune Highway Near Race Course Road Wanowrie Pune Maharasthra |
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical College |
| Address |
Southern command Solapur-Pune Highway Near Race Course road Wanowrie Pune Maharasthra 411040 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sakthimurugan R |
Armed Forces Medical College |
Department of Sports Medicine Building no 3 old command complex near Solapur highway wanowarie
Pune
MAHARASHTRA |
8667893630
rsm1148@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Armed Forces Medical College Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S835||Sprain of cruciate ligament of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ACL rehab group |
After surgery patients will undergo supervised and unsupervised ACL rehabilitation protocol |
| Comparator Agent |
Normal population |
Participants with no injuries, surgeries , comorbidities |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Participants who are willing for the study |
|
| ExclusionCriteria |
| Details |
Participants with any other knee ligament injuries
Participants with meniscal injuries
Participants with osteoarthritis, rheumatoid arthritis and osteochondral defect
Participants with previous knee surgery
Participants unwilling due to any reason
Patients with chronic illness like diabetes mellitus, hypertension, CKD etc
Patients with generalised ligament laxity |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Gait pattern
Hamstring and quadriceps strength
Foot pressure distribution
|
24 weeks after ACL rehabilitation
Foot pressure distribution |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Thigh girth
Lysholm score |
24 weeks after ACL rehabilitation |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To compare the differences in hamstring and quadriceps strength between supervised and unsupervised rehabilitation program 2. To compare the foot pressure distribution between supervised and unsupervised rehabilitation program 3. To compare the differences in gait pattern between supervised and unsupervised rehabilitation program of unilateral ACL reconstruction cases 4. To compare the differences in mid-thigh girth between supervised and unsupervised rehabilitation program of unilateral ACL reconstruction cases |