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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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