| 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
|
|
|
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
|
|
|
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 reconstructionootball players, so there is need to study the comparison between the
effect of BFOT with conventional treatment for chronic ACL reconstruction. 24 patient
will beelected 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
|