| CTRI Number |
CTRI/2025/09/094906 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| 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
|
Effectiveness of combining blood flow restriction training with regular strength training help improve weak thigh muscles in people recovering from ACL surgery |
|
Scientific Title of Study
|
Effectiveness of Blood Flow Restriction Training With Resistance Training
On Reduced Quadriceps Strength In Participants On Late Phase Of Anterior Cruciate Ligament Rehabilitation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Momin Mohammed Yusha |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. G. D. Pol foundation, YMT college of physiotherapy |
| Address |
Dr.G.D.Pol Foundation, YMT College Of Physiotherapy,Institutional Area ,Belpada Rd,Sector 4 ,Kharghar ,Navi Mumbai ,Maharashtra
Raigarh MAHARASHTRA 410210 India |
| Phone |
7021657286 |
| Fax |
|
| Email |
yushamomin121@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Rincy Sibi |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor at Dr. G. D. Pol foundation, YMT college of physiotherapy |
| Address |
Dr. G. D. Pol Foundation, YMT College of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra 410210
Raigarh MAHARASHTRA 410210 India |
| Phone |
8600647937 |
| Fax |
|
| Email |
rincy.mathew60@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Momin Mohammed Yusha |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. G. D. Pol foundation, YMT college of physiotherapy |
| Address |
Dr. G.D. Pol Foundation, YMT College of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra
Raigarh MAHARASHTRA 410210 India |
| Phone |
7021657286 |
| Fax |
|
| Email |
yushamomin121@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Yusha Momin PT |
| Address |
Dr. G. D. Pol Foundation, YMT College of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra 410210
|
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Yusha Momin |
YMT College Of Physiotherapy ,Dr. G. D. Pol Foundation |
305, Musculoskeletal Department OPD, Dr. G. D. Pol Foundation, YMT College of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra 410210
Raigarh MAHARASHTRA |
7021657286
yushamomin121@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| YMT COP Institutional Ethics Comittee |
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 |
Blood flow restriction therapy with Resistance training |
Blood flow restriction therapy with Resistance training for 6 weeks |
| Comparator Agent |
Resistance training |
Resistance training for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patient who underwent anterior cruciate ligament
reconstruction 10-12 week before.
4) Able to understand and follow simple verbal instruction.
5) Both right and left sided patients are included.
6) Good Patellar Mobility |
|
| ExclusionCriteria |
| Details |
1.Previous knee surgery or total knee replacement
2.History of lower limb fractures or neurological conditions affecting gait.
3.Participation in a structured exercise program within the last 3 month
4.Severe knee OA (Kellgren & Lawrence grade 4)
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hand-held dynamometer |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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)
|
27/09/2025 |
| 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 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
|
The anterior cruciate ligament (ACL) plays a key role in stabilizing the knee joint, and its injury is common, particularly in young athletes and sports-related activities. Even after surgical reconstruction, deficits in quadriceps strength and size can persist, especially in the late rehabilitation phase (12–20 weeks post-surgery), which is critical for returning to sports and advanced activities. Quadriceps weakness compromises knee stability, delays recovery, and increases the risk of reinjury.
Blood Flow Restriction Training (BFRT) is a method that uses controlled restriction of blood flow during low-load resistance exercises, leading to greater muscle activation, metabolic stress, and strength gains. Previous studies suggest BFRT may improve quadriceps strength and muscle mass after ACL reconstruction, but evidence remains limited.
This randomized controlled trial will evaluate the effectiveness of BFRT combined with resistance training versus resistance training alone in participants aged 18–40 years, 10–12 weeks post-ACL reconstruction, with reduced quadriceps strength. A total of 36 participants will be included and randomly assigned to two groups. Group A will receive BFRT with resistance training, while Group B will perform only resistance training. Both groups will train three days per week for four weeks.
Quadriceps strength will be assessed using a hand-held dynamometer before and after the intervention. Exercises will include split squats, medial step downs, single-leg presses, walking lunges, and leg extensions. Data will be analyzed using appropriate statistical tests, with significance set at p < 0.05.
The study aims to determine whether BFRT with resistance training provides superior improvements in quadriceps strength compared to conventional resistance training alone, offering a potentially effective rehabilitation strategy for late-phase ACL recovery. |