| CTRI Number |
CTRI/2026/01/102169 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Blood flow restriction and whole body vibration therapy combined effect on athletes after ACL surgery. |
|
Scientific Title of Study
|
Effect of Blood Flow Restriction Therapy along with
Whole Body Vibration in Athletes
after Anterior Cruciate Ligament Reconstruction |
| 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 Irshad Ahmad |
| Designation |
Assistant Professor Physiotherapy |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna International Institute of Research and Studies Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana
Faridabad
HARYANA
121001
India |
| Phone |
9911878341 |
| Fax |
|
| Email |
irshad.fahs@mriu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Shivangi Sharma |
| Designation |
PhD Scholar MRIIRS |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna International Institute of Research and Studies Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana
Faridabad
HARYANA
121001
India |
| Phone |
9711076688 |
| Fax |
|
| Email |
shivangitansh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivangi Sharma |
| Designation |
PhD Scholar MRIIRS |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna International Institute of Research and Studies Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana
Faridabad
HARYANA
121001
India |
| Phone |
9711076688 |
| Fax |
|
| Email |
shivangitansh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Total Healthsums ND-10 Pitampura Delhi |
|
|
Primary Sponsor
|
| Name |
Shivangi Sharma |
| Address |
PhD Scholar Department of Physiotherapy Faculty of Allied Health Sciences Manav Rachna International Institute of Research And Studies Sector 43 Surajkund Road Faridabad HARYANA 121001 India
Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121010 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shivangi Sharma |
Manav Rachna International Institute of Research and Studies |
Physiotherapy and Rehabilitation Department Ground floor Manav Rachna Sports Science Centre School of Allied Health Sciences Manav Rachna International Institute of Research and Studies Sector 43 Surajkund Road Faridabad HARYANA 121001 India
Faridabad
HARYANA |
9711076688
shivangitansh@gmail.com |
| Dr Pramod |
Total Healthsums Complete Physiotherapy Solutions |
ND-10, Basement Physiotherapy Department Pitampura, New Delhi
North West
DELHI |
7838921020
totalhealthsumsofficially@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MANAV RACHNA DENTAL COLLEGE |
Approved |
| Total Healthsums |
No Objection Certificate |
|
|
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 |
| Comparator Agent |
Blood Flow Restriction |
The athletes will perform exercises with an air tourniquet tied on the proximal thigh. Patients will be asked to do exercises three times a week for 8 weeks. |
| Intervention |
Blood Flow Restriction along with Whole Body Vibration |
In this group, the athletes will exercise on a whole body vibration platform with an air tourniquet on the proximal thigh. Patients will be asked to do exercises three times a week for 8 weeks. |
| Comparator Agent |
Whole Body Vibration |
In this group, the athletes will perform exercises on a vibrating platform.Patients will be asked to do exercises three times a week for 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Athletes with first arthroscopic reconstruction of ACL with or without menisectomy with any graft in a single limb. |
|
| ExclusionCriteria |
| Details |
Earlier history of lower limb injury, bilateral ACL injuries, contradictory conditions of whole body vibration and blood flow restriction such as thrombosis, pregnancy, epilepsy, cardiovascular or neurological conditions. |
|
|
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 |
| Isokinetic Strength |
6th week - 14th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Peak torque |
12th week -14th week |
| Muscle girth |
6th week -14th week |
| Static balance |
6th week - 14th week |
| Dynamic balance |
6th week - 14th week |
| Joint Position Sense |
6th week - 14th week |
| Tegner Lysholm Knee Score |
14th week |
| KOOS |
14th week |
| VAS |
6th week - 14th week |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
02/02/2026 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shivangitansh@gmail.com].
- For how long will this data be available start date provided 02-03-2027 and end date provided 02-01-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Anterior Cruciate Ligament Reconstruction is the optimal decision for an athlete to return to sports after an ACL tear. It is a surgical intervention in which the torn ACL ligament is grafted to improve the knee’s functions. Neuromuscular deficits are common after ACL injury. Functional recovery of the knee is incomplete in an athlete with ACL reconstruction if the rehabilitation does not include neuromuscular training.
This study aims to examine the effect of Blood flow restriction training and whole-body vibration on muscular, functional, and psychological performance in athletes following ACL reconstruction. It will also distinguish this result from the whole-body vibration-only protocol and blood flow restriction training individually.
This study will be a Randomized Control Trial. There will be two control groups and one experimental group. Sample size will be 96. Subjects will be selected using inclusion and exclusion criteria. These subjects will then be randomly assigned to the three groups. Outcome measures will be Pain, KOOS, Muscle performance by Muscle girth, Isometric Strength and Peak Torque, functional performance by Balance-Static and Dynamic, Proprioception and Tegner Lysholm Knee Score. The experimental group will perform blood flow restriction exercises on the whole body vibration platform. One control group will perform whole-body vibration only, and the other will perform blood flow restriction only.
|