| 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
|
|
|
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
|
|
|
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. |