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CTRI Number  CTRI/2024/09/073880 [Registered on: 13/09/2024] Trial Registered Prospectively
Last Modified On: 11/09/2024
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   Impact of Blood Vessel Compression Training v/s Conventional Exercises for Knee Injuries in Players 
Scientific Title of Study   Effect of Intense Behaviour of Blood Flow Occlusion Training (BFOT) and Conventional Rehabilitation on Chronic ACL Reconstruction among the Athletes 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Thiagarajan Subramanian 
Designation  Professor 
Affiliation  Lovely Professional University 
Address  Block 3,Room no-105,Department of Physiotherapy,School of Allied Medical Sciences, Lovely Professional University Phagwara-144411, Punjab, India

Kapurthala
PUNJAB
144411
India 
Phone  9789247047  
Fax    
Email  strajanpt@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prishita Kumar 
Designation  MPT Sports PG Student 
Affiliation  Lovely Professional University 
Address  Block 3,Room no-105,Department of Physiotherapy,School of Allied Medical Sciences, Lovely Professional University Phagwara-144411, Punjab, India

Kapurthala
PUNJAB
144411
India 
Phone  7527889699  
Fax    
Email  prishitakumar6558@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Thiagarajan Subramanian 
Designation  Professor 
Affiliation  Lovely Professional University 
Address  Block 3,Room no-105,Department of Physiotherapy,School of Allied Medical Sciences, Lovely Professional University Phagwara-144411, Punjab, India

Kapurthala
PUNJAB
144411
India 
Phone  9789247047  
Fax    
Email  strajanpt@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Block 3,Room no-101,School of Allied Medical Sciences, Lovely Professional University Phagwara-144411, Punjab, India 
 
Primary Sponsor  
Name  Thiagarajan Subramanian 
Address  Block 3,Room no-105,Department of Physiotherapy,School of Allied Medical Sciences, Lovely Professional University Phagwara-144411, Punjab, India 
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 
Dr Prishita Kumar  Lovely Professional University Hospital  Block 3,Room no-107,Department of Physiotherapy,School of Allied Medical Sciences, Lovely Professional University Phagwara-144411,Punjab, India
Kapurthala
PUNJAB 
7527889699

prishitakumar6558@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Lovely Professional University(IEC-LPU)  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 Occlusion Training   For 6 weeks 4 days in a week for approximately 40-45 minutes. It includes strength training, aerobic exercise with post fatigue balance training, agility and eccentric control exercises using BFOT cuffs. 
Comparator Agent  Conventional Treatment   For 6 weeks 4 days in a week for approximately 35-40 minutes. It includes strength training, aerobic exercise with post fatigue balance training, agility and eccentric control exercises. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Male 
Details  1. Professional Male Football Players
2. Players who Practice regularly
3. Aged between 18-30 years
4. Players Underwent ACL reconstruction Surgery (3-4 months)
5. Unilateral ACL Surgery
6. Injury occurred during play or practice of Sports
7. No History of Deep Vein Thrombosis  
 
ExclusionCriteria 
Details  1. Acute ACL Reconstruction Surgery
2. Multiple Ligaments rupture
3. Intra-articular injections in last 5-6 months
4. Recent Injuries in Lower Limb
5. Systemic or Neurological Problems
6. Revision of ACL Reconstruction Surgery
7. Peripheral Arterial Disease
8. Quadriceps Tendon Graft 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Muscle Strength
2. Limb Girth
3. International Knee Documentation Committee (IKDC) Score 
Baseline, week 2, week 4, and completion week 6  
 
Secondary Outcome  
Outcome  TimePoints 
1. Single leg Hop test
2. Single leg vertical Jump test 
Baseline, week 2, week 4, and completion week 6  
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   15/10/2024 
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="0"
Months="6"
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  injuries are very common these days which affect the Performance of the  Football players. ACL reconstruction is the choice of treatment option followed by complete tear of the ligament. Rehabilitation plays an important role after ACL reconstruction. Conventional treatment including neuro-muscular electrical stimulation , open chain kinetic exercise, close chain kinetic exercise plays a significant role in rehabilitation. Rehabilitation with advanced treatment protocols including Blood Flow Occlusion Training plays a crucial role after the surgery and helps the patient to return to sports. There are limited studies on the effect of Blood Flow Occlusion Training on Chronic ACL reconstruction in Football players, so there is need to study the comparison between the effect of BFOT with conventional treatment for chronic ACL reconstruction. 24 patient will be selected  based on inclusion and exclusion criteria. The subjects will get both verbal and written information about the study and then the interested subjects were requested to sign the informed consent. The subjects will be assigned into two groups, namely Group A and B. Group A Subjects will receive the supervised exercise using Blood Flow Occlusion Training and Group B subjects will receive the Conventional rehabilitation treatment. Pretest readings of Limb Girth, Muscle Strength, Single leg hop test, single leg vertical jump test and International Knee Documentation Committee Score. The intervention will be given for 6 weeks, 4 days per week then post reading will be  recorded on 2nd , 4th  and after completion of the intervention i.e 6th  week

 
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