| CTRI Number |
CTRI/2025/08/093591 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Can Online Rehab Work as Well as At-Home Rehab for Athletes Recovering from ACL Surgery |
|
Scientific Title of Study
|
Feasibility and Effectiveness
of Telerehabilitation Versus Home-Based
Rehabilitation in Athletes Post ACL
Reconstruction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mansi |
| Designation |
Post Graduate Student |
| Affiliation |
College of Physiotherapy,PGIMS Rohtak |
| Address |
Physiotherapy Department, E-Block, PGIMS, Rohtak
HARYANA
124001
India
NIL
Rohtak
HARYANA
124001
India |
| Phone |
09306457676 |
| Fax |
|
| Email |
mansitalwar23362@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Dhankher |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy,PGIMS Rohtak |
| Address |
Physiotherapy Department, E Block, PGIMS, Rohtak
HARYANA
124001
India
NIL
Rohtak
HARYANA
124001
India |
| Phone |
8607156999 |
| Fax |
|
| Email |
Poonam.dhankher.jhajhria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Dhankher |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy,PGIMS Rohtak |
| Address |
Physiotherapy Department, E Block, PGIMS, Rohtak
HARYANA
124001
India
NIL
Rohtak
HARYANA
124001
India |
| Phone |
8607156999 |
| Fax |
|
| Email |
Poonam.dhankher.jhajhria@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt.B.D.Sharma PGIMS,Rohtak,Haryana,India,124001 |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy,PGIMS,Rohtak |
| Address |
Physiotherapy Department, E Block,College OF Physiotherapy,PGIMS,Rohtak
HARYANA
124001
India |
| 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 Poonam Dhankher |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
Ch.Ranbir Singh OPD, Room NO.39, PGIMS Rohtak, Department of Physiotherapy, E Block, PGIMS Rohtak
HARYANA
124001
India
Rohtak
HARYANA |
8607157000
Poonam.dhankher.jhajhria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Supervised post-ACL reconstruction rehabilitation |
0–2 Weeks: Control swelling, regain full extension, flexion equal to more than 90 degree, activate quads, partial then full weight-bearing with brace.
2–6 Weeks: Achieve full ROM, normal gait, build quad or hip strength, start balance training, bike, mini-squats, step-ups.
6–12 Weeks: Strength equals to more than 70 percent of opposite leg, improve proprioception, leg press, lunges, step-downs, wobble board, light plyometrics if cleared. |
| Comparator Agent |
Unsupervised home-based post-ACL reconstruction rehabilitation |
0–2 Weeks: Control swelling, regain full extension, flexion equal to more than 90 degree, activate quads, partial then full weight-bearing with brace.
2–6 Weeks: Achieve full ROM, normal gait, build quad or hip strength, start balance training, bike, mini-squats, step-ups.
6–12 Weeks: Strength equals to more than 70 percent of opposite leg, improve proprioception, leg press, lunges, step-downs, wobble board, light plyometrics if cleared. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Male and female athletes aged 18-35 years.
Confirmed ACL rupture on MRI requiring surgical reconstruction. Athletes who have undergone ACL reconstruction within the last 2 weeks.
Participants who are willing to adhere to the study protocol for the full duration
|
|
| ExclusionCriteria |
| Details |
Athletes with multiple ligament injuries (MCL, LCL and PCL involvement). History of previous knee surgery apart from ACL reconstruction. Neurological, cardiac, or metabolic disorders affecting rehabilitation outcomes.Athletes who are non-competitive/recreational players without a structured training history.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Range of motion
Proprioception
Pressure pain threshold
quality of life |
Baseline
2 weeks
4 weeks
8 weeks
12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of life
|
Baseline
2 weeks
4 weeks
8 weeks
12 weeks
|
| Knee function |
Baseline
2 weeks
4 weeks
8 weeks
12 weeks
|
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
07/09/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Title of the study: Feasibility and Effectiveness of
Telerehabilitation Versus Home-Based Rehabilitation
in Athletes
Post ACL Reconstruction.
There are 44 participants in all (22 in the control group and 22 in the intervention group). Every participant will undergo screening in accordance with the inclusion and exclusion criteria. Criteria for Inclusion:Male and female athletes aged 18-35
years, confirmed ACL rupture on MRI
(full-thickness tear requiring surgical reconstruction), athletes who have
undergone ACL reconstruction, and post-operative recruitment within the first 2
weeks post-surgery.
Athletes with multiple ligament injuries (MCL, LCL, PCL, etc.) or a history of previous knee surgery apart from ACL reconstruction will be excluded.
Before beginning the study, informed consent will be taken from each
participant; after taking consent, participants will be explained about the study. This study will only recruit patients who meet the inclusion criteria. A
minimum of 22 participants per group (44 in total) will be recruited. Randomised
allocation (1:1) to supervised telerehabilitation vs. home-based
self-rehabilitation groups, stratified by gender to ensure equal
representation. Both groups follow standardised ACL rehabilitation protocols
for 3 months. Assessments were conducted at 2, 4, 8, and 12 weeks post-rehabilitation. Final
analysis compares rehabilitation efficacy between genders.
Participants in the intervention group could access the rehabilitation content
applicable to their current phase each day and confirm their willingness to
execute it through the application. Additionally, participants have the
capability to communicate with therapists via the mobile phone application,
enabling them to send text, voice messages, images, and videos throughout the
entire experiment. Participants in the control group could only receive a
graphic and textual minimal postoperative rehabilitation plan on the mobile
phone application. However, the participants will not inform the frequency and
intensity of the rehabilitation items. They could not communicate with
therapists online. Participants in the control group were expected to exercise
unsupervised postoperatively. All participants went to the outpatient clinic
for follow-up by a physiotherapist to provide face-to-face guidance for exercise
methods.
|