| CTRI Number |
CTRI/2025/06/088880 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
15/06/2025 |
| 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
|
Effect of Core muscles exercises Versus
Regular Physiotherapy treatment on Muscle strength in Patients after Surgery of Anterior Cruciate Ligament injury in knee.
|
|
Scientific Title of Study
|
Effect Of Core Stabilization Exercises Versus
Conventional Physiotherapy On Muscle Strength In
Patients Post Anterior Cruciate Ligament Reconstruction-A Randomized Controlled Trial.
|
| 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 Vasavi B |
| Designation |
Post Graduate Student |
| Affiliation |
VSPMs College Of Physiotherapy Nagpur |
| Address |
Musculoskeletal Department VSPMs College Of Physiotherapy Nagpur Maharashtra
Nagpur
MAHARASHTRA
440016
India |
| Phone |
7795968667 |
| Fax |
|
| Email |
vasavib61@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasavi B |
| Designation |
Post Graduate Student |
| Affiliation |
VSPMs College Of Physiotherapy Nagpur |
| Address |
Musculoskeletal Department VSPMs College Of Physiotherapy Nagpur Maharashtra
Nagpur
MAHARASHTRA
440016
India |
| Phone |
7795968667 |
| Fax |
|
| Email |
vasavib61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vasavi B |
| Designation |
Post Graduate Student |
| Affiliation |
VSPM COLLEGE OF PHYSIOTHERAPY NAGPUR |
| Address |
Musculoskeletal Department VSPMs College Of Physiotherapy Nagpur Maharashtra
Nagpur
MAHARASHTRA
440016
India |
| Phone |
7795968667 |
| Fax |
|
| Email |
vasavib61@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vasavi B |
| Address |
Musculoskeletal Department VSPMs College Of Physiotherapy Nagpur Maharashtra |
| 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 Vasavi B |
VSPMs College of Physiotherapy and Lata Mangeshkar Hospital |
Musculoskeletal Department VSPMs College Of Physiotherapy
Nagpur
MAHARASHTRA |
7795968667
vasavib61@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE VSPMs COLLEGE OF PHYSIOTHERAPY |
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 |
| Comparator Agent |
Conventional exercises |
Group will receive conventional physiotherapy which includes static Quadriceps exercises, static hamstring exercises, knee bending with heel slides, supine hip abduction-adduction with LKB. Straight leg raise with LKB, side lying hip abduction. Total duration of such intervention is 4 weeks |
| Intervention |
CORE STABILIZATION EXERCISES |
Core stability is defined as the dynamic control of
the lumbopelvic-hip complex that facilitates the transfer of torque
and momentum between the lower and upper extremities during
gross motor tasks of sports, exercises, and daily living. Total duration of such intervention is 4 weeks
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients who underwent ACL Reconstruction
Individuals aged between 20-40 years
Patients who are willing to participate in the study.
Both genders
|
|
| ExclusionCriteria |
| Details |
Participants with associated fracture
previous nerve injury of lower limbs
Lumbar radiculopathy
Neurological condition such as upper motor neuron lesions
Infections in the operated region
Patients with previous surgeries on the injured knee
Patients experiencing an injury of the trunk or lower extremity after
post-operative period |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Muscle strength is the primary outcome and it will be assessed on Day 1 and at the end of 4 weeks of treatment |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2.Y Balance score
3. Numerical Pain Rating Scale
4.IKDC Scale |
18 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
26/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/06/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
This study titled as EFFECT OF CORE STABILIZATION EXERCISES VERSUS CONVENTIONAL PHYSIOTHERAPY ON MUSCLE STRENGTH IN PATIENTS POST ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION- A RANDOMIZED CONTROLLED TRIAL comprises of two groups in which one group receives core stabilization exercises as an intervention and the other group receives conventional physiotherapy treatment in patients post ACL reconstruction. The outcome measures in this study are muscle strength, Y Balance score, NPRS and IKDC scale. |