| CTRI Number |
CTRI/2026/01/102275 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The Role of Blood Flow Restriction Training in Building Strength and Performance in ACL Rehabilitation in Indian Athletes |
|
Scientific Title of Study
|
Enhancing ACL Rehabilitation in Indian Athletes: Evaluating the effects of Blood Flow Restriction Training on Muscle Strength, Hypertrophy and Functional Performance |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sadhan Berry |
| Designation |
Associate Professor |
| Affiliation |
ISIC INSTITUTE OF REHABILITATION SCIENCES |
| Address |
TP- 112, Maurya ENCLAVE, Pitampura, DELHI-110034 SECTOR - C , VASANT KUNJ, NEW DELHI -110070 South West DELHI 110034 India |
| Phone |
9818098441 |
| Fax |
|
| Email |
sadhan27@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sadhan Berry |
| Designation |
Associate Professor |
| Affiliation |
ISIC INSTITUTE OF REHABILITATION SCIENCES |
| Address |
TP- 112, Maurya Enclave, Pitampura, DELHI-110034 SECTOR - C , VASANT KUNJ, NEW DELHI -110070 South West DELHI 110034 India |
| Phone |
9818098441 |
| Fax |
|
| Email |
sadhan27@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sadhan Berry |
| Designation |
Associate Professor |
| Affiliation |
ISIC INSTITUTE OF REHABILITATION SCIENCES |
| Address |
TP- 112, Maurya Enclave, Pitampura DELHI-110034 SECTOR - C , VASANT KUNJ, NEW DELHI -110070 South West DELHI 110034 India |
| Phone |
9818098441 |
| Fax |
|
| Email |
sadhan27@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of Physiotherapy, SGT University, Gurgaon |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Pooja Anand |
SGT University |
Room no. 419, School of Physiotherapy, Block-B, 4th Floor, Gurgaon HARYANA |
9810240409
pooja.physiotherapy@sgtuniversity.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee faculty of physiotherapy |
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 |
BFR Group |
Total duration: 8 weeks,
Week 0–2 (Phase I – Acute / Protection Phase):
Goals: Control pain and effusion, restore knee range of motion, prevent quadriceps inhibition.
Interventions: Cryotherapy, compression, heel slides, patellar mobilization.
BFR Exercises: Quadriceps sets, straight leg raises, ankle pumps at 60% LOP.
Week 3–4 (Phase II – Early Strengthening Phase):
Goals: Improve muscle strength and achieve full knee ROM.
BFR Exercises: Seated knee extension, mini squats, step-ups, hamstring curls using resistance bands at 70–80% LOP.
Week 5–6 (Phase III – Neuromuscular Control Phase):
Goals: Enhance balance, proprioception, and dynamic knee stability.
Exercises: Split squats, lateral step-downs, single-leg stance with perturbations. BFR used selectively for strengthening exercises.
Week 7–8 (Phase IV – Functional Strengthening Phase):
Goals: Prepare athlete for return to sport-specific activities.
Exercises: Lunges, Bulgarian squats, agility drills, controlled plyometric activities. BFR may be used as an adjunct for accessory strength training. |
| Comparator Agent |
Conventional therapy |
Total duration: 8 weeks
ACL Rehabilitation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
MRI-confirmed partial ACL tear involving less than 50% of fibers
Recreational or competitive Indian athletes
Absence of knee instability or giving-way episodes |
|
| ExclusionCriteria |
| Details |
Complete ACL rupture
Associated Grade III ligament injuries
Meniscal root tears
History of vascular disorders or deep vein thrombosis
Previous knee surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quadriceps and hamstring muscle strength |
baseline, 4 weeks, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Muscle hypertrophy, Functional performance |
0 weeks, 4 weeks, 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
10/02/2026 |
| 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 Applicable |
| 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
|
Anterior Cruciate Ligament (ACL) injuries are common among young Indian athletes and often result in persistent deficits in muscle strength and functional performance despite structured conservative rehabilitation. Quadriceps and hamstring weakness, impaired functional capacity, and delayed return to sport increase the risk of re-injury and limit athletic performance. Blood Flow Restriction (BFR) training has emerged as a novel rehabilitation strategy that enables strength and hypertrophy gains using low-intensity exercise, thereby reducing joint stress and potentially enhancing recovery outcomes.This study aims to evaluate the effectiveness, safety, and feasibility of adding BFR training to a conventional rehabilitation program in young Indian athletes with unilateral ACL injuries managed conservatively. The primary objective is to compare changes in quadriceps and hamstring muscle strength between the BFR group and a control group receiving conventional exercise alone. Secondary objectives include assessing functional performance, return-to-sport readiness, adherence, and adverse events. This will be a single-blind, randomized controlled trial involving 60 Indian athletes aged 18–35 years with MRI-confirmed unilateral ACL injury. Participants will be randomly allocated to either a 8-week BFR-assisted rehabilitation program or a standard rehabilitation program. Outcomes will be assessed at baseline, 4 weeks, and 8 weeks using isokinetic strength testing, muscle hypertrophy measures, functional performance tests, and validated patient-reported outcome measures. |