| CTRI Number |
CTRI/2026/01/102429 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Graded Motor Imagery for patient recovery after Anterior Cruciate Ligament reconstruction |
|
Scientific Title of Study
|
Effect of Graded Motor Imagery for Enhanced Recovery in rehabilitation of individuals after Anterior Cruciate Ligament Reconstruction on Pain, Mobility, Kinesiophobia, Mental imagery ability and Functions: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rutuja Phadke |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to University) |
| Address |
Bharati Vidyapeeth (Deemed to be University), School of Physiotherapy, Sangli
Sangli
MAHARASHTRA
416410
India |
| Phone |
8669155407 |
| Fax |
|
| Email |
rutuja.phadke9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rutuja Phadke |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to University) |
| Address |
Bharati Vidyapeeth (Deemed to be University), School of Physiotherapy, Sangli
Sangli
MAHARASHTRA
416410
India |
| Phone |
8669155407 |
| Fax |
|
| Email |
rutuja.phadke9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rutuja Phadke |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to University) |
| Address |
Bharati Vidyapeeth (Deemed to be University), School of Physiotherapy, Sangli
Sangli
MAHARASHTRA
416410
India |
| Phone |
8669155407 |
| Fax |
|
| Email |
rutuja.phadke9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Medical College and Hospital, Sangli-Miraj Road, Wanleswadi, Sangli Maharashtra, India- 416416 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Rutuja Phadke |
Bharati Vidyapeeth (Deemed to University) |
OPD no. 18, Orthopedic Physiotherapy department, Bharati Vidyapeeth Medical College and Hospital, Sangli-Miraj Road, Wanleswadi, Sangli Maharashtra, India- 416416
Sangli
MAHARASHTRA |
08669155407
rutuja.phadke9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Bharati Vidyapeeth (Deemed to by University) Medical college % Hospital, Sangli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Graded Motor Imagery and Standard Rehabilitation |
GMI aims to facilitate cortical reorganization via neuroplasticity, gradually activating motor cortical areas and reducing disinhibition to decrease pain and improve movement. |
| Comparator Agent |
Standard rehabilitation |
Standard Pre operative and Post operative rehabilitation will be given to both the groups |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) All gender Aged 18- 45.
2) Individuals with a confirmed diagnosis of Grade 2 or Grade 3 ACL tear on MRI and who are scheduled for reconstructive surgery.
3) Individuals who opted for Spinal anesthesia during the surgical procedure.
4)Able to follow verbal instructions and cognitively engage with imagery techniques (Clinician judgment)
|
|
| ExclusionCriteria |
| Details |
1. Not willing to participate
2. Visual or cognitive impairments that preclude engagement in GMI tasks
3. Non-compliance with rehab protocols or inability to attend follow-up sessions
4. Uncontrolled systemic illness or comorbidities
(e.g., uncontrolled diabetes, severe cardiac or respiratory disease)
5. Severe psychiatric illness (e.g., psychosis, major depression) that may interfere with participation
6. History of previous lower limb injury/ trauma.
|
|
|
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 |
| Pain, Range of motion, Kinesiophobia, Motor imagery ability, Functions |
at baseline 3 weeks 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quadriceps & Hamstring Strength,Postural Stability, Length of Hospital Stay, Patient Satisfaction |
at baseline 3 weeks 3 months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 4 |
|
Date of First Enrollment (India)
|
11/02/2027 |
| 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="2"
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
|
Individuals diagnosed with ACL injury and scheduled for reconstructive surgeries will be screened for eligibility using inclusion and exclusion criteria. The study procedures will be explained to the participants and informed consent will be obtained. The demographic data and all the baseline outcome measures will be assessed. All the participants will then be divided into two groups using computer-generated randomization sequence number table. The intervention group will receive Graded motor imagery in addition to the traditional rehabilitation (GMI: 2 week preoperative, perioperative and 3 week postoperative plus Traditional rehabilitation: 2 week preoperative, 3 peek post operative and home exercise program till 3 month follow up)whereas group B will only receive Standard Rehabilitation Traditional rehabilitation: 2 week preoperative, 3 peek post operative and home exercise program till 3 month follow up) The outcome measures will be assessed at 3 timeframes. Baseline; At 5 week (3week post op) and ; 3 month follow up. The home exercise program will be monitored by Telephonic follow up and home diary. Any adverse events will be managed by qualified personnel, and appropriate care will be provided if required |