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CTRI Number  CTRI/2024/07/071487 [Registered on: 29/07/2024] Trial Registered Prospectively
Last Modified On: 27/07/2024
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   Exercise Regimen for Anterior Cruciate Ligament Reconstruction with Blood Flow Restriction and Backward Walking 
Scientific Title of Study   Effect of Blood Flow Restriction and Retrowalking on Functional Ability in Individuals with Anterior Cruciate Ligament Reconstruction- 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  Dr Chinmayee Laxmikant Shah 
Designation  MPT Resident 
Affiliation  MGM Institute of Physiotherapy, Aurangabad 
Address  Department of Musculoskeletal Physiotherapy, MGM Institute of Physiotherapy, N-6,CIDCO, Aurangabad

Aurangabad
MAHARASHTRA
431001
India 
Phone  9146031999  
Fax    
Email  chinmaye20031999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanket Mungikar 
Designation  Associate Professor, Department of Musculoskeletal Physiotherapy 
Affiliation  MGM Institute of Physiotherapy, Aurangabad 
Address  Department of Musculoskeletal Physiotherapy, MGM Institute of Physiotherapy, N-6, CIDCO, Aurangabad

Aurangabad
MAHARASHTRA
431001
India 
Phone  9730770107  
Fax    
Email  sanketmungikar@mgmiop.edu.in  
 
Details of Contact Person
Public Query
 
Name  Chinmayee Shah 
Designation  MPT Resident 
Affiliation  MGM Institute of Physiotherapy, Chh. Sambhajinagar 
Address  Department of Musculoskeletal Physiotherapy, MGM Institute of Physiotherapy, N-6, CIDCO, Aurangabad

Aurangabad
MAHARASHTRA
431005
India 
Phone  9146031999  
Fax    
Email  chinmaye20031999@gmail.com  
 
Source of Monetary or Material Support  
MGM Institute of Physiotherapy, N-6 Cidco, Aurangabad 431001, Maharashtra, India 
 
Primary Sponsor  
Name  MGM Institute of Physiotherapy Aurangabad 
Address  MGM Institute of Physiotherapy, N-6 Cidco, Aurangabad, 431001, Maharashtra, India 
Type of Sponsor  Private medical college 
 
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 
Dr Chinmayee Shah  Musculoskeletal OPD, MGM Physiotherapy and Rehabilitation Centre, N-6, CIDCO, Aurangabad  C Building, MGM Physiotherapy and Rehabilitation Centre, N-6 Cidco, Aurangabad
Aurangabad
MAHARASHTRA 
9146031999

chinmaye20031999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGM Institute of Physiotherapy Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Blood Flow Restriction and Retrowalking for 4 weeks, 3 days per week  Blood Flow Restriction is added at 40% of the arterial occlusion pressure of the individual during exercise. Retro walking in the 3rd week of the treatment  
Comparator Agent  Conventional Physiotherapy for 4 weeks, 3 days per week  Static Quads, Static Hams, SLR, Abduction SLR, Hamstring Curls, Multiple angle SLR (In standing), forward and side walking, proprioception, and balance training. All the exercises will be performed for 4 weeks, 3 days per week for 10 repetitions 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Patients who completed 3 weeks post ACL reconstruction surgery
2. Autograft taken for surgery
3. No previous physiotherapy taken.
 
 
ExclusionCriteria 
Details  1. Any recent injury or trauma
2. Any systemic disease or arthritis
3. Any unstable cardiorespiratory and neurological comorbidities
4. Any fixed deformities
5. Unwilling to exercise or Participate
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Functional Ability  Baseline and at 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Risk of re-injury   Baseline and at 4 weeks 
Proprioception  Baseline and at 4 weeks 
Kinesiophobia  Baseline and at 4 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 3 
Date of First Enrollment (India)   10/08/2024 
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  

The Anterior Cruciate Ligament (ACL) is a crucial ligament for the knee joint’s normal motion. Injury to the ACL is more likely to result in knee instability than injury to other knee ligaments. The annual prevalence of ACL injuries is more than 2 million globally of which 200,000 are believed to occur in India. Of these 100,000 are reconstructed. The ACL injury creates deficits in the muscle strength, muscle mass, proprioception and functional ability of the individual. Currently, majority of surgeons advise that individuals who are active and have considerable functional demands on their knees, such as cutting motions, should be offered ligament reconstruction surgery. Following surgery, even after intensive rehabilitation, the muscle quality and symptoms like proprioception and risk of re-injury fail to enhance. Blood flow restriction training, developed by Dr. Yoshika Sato has been gaining ground recently in the rehabilitation following ACL reconstruction. It involves reducing the venous return flow while only partially restricting the arterial inflow. Retrowalking, is another treatment that is being used in the rehabilitation protocol of ACL reconstruction individuals. The well-known benefit of retro walking is reducing knee stress. The role of retro walking is of great significance in knee rehabilitation programs. The exercise program will be followed by the individuals for 4 weeks, thrice a week. assessment will be done at baseline and at 4 weeks. Mean and SD will be calculated for quantitative variables. Data will be represented in graphical form. Two sample t-test will be used to compare between group differences. Paired t-test will be used to compare within group difference. P value of < 0.05 will be considered statistically significant.

 
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