| CTRI Number |
CTRI/2024/12/078470 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Graded Motor Imagery on Pain,Range of motion,Fear of movement,Functional status in Patients with Rotator Cuff Surgery: A Pilot Randomized Controlled Trial |
|
Scientific Title of Study
|
EFFECTIVENESS OF GRADED MOTOR IMAGERY IN SUBJECTS WITH POST-OPERATIVE ROTATOR CUFF REPAIR ON PAIN, RANGE OF MOTION, KINESIOPHOBIA AND FUNCTIONAL STATUS-A PILOT 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 |
Vandana Chandaragi |
| Designation |
post graduate student |
| Affiliation |
Kaher Institute of Physiotherapy Belgaum |
| Address |
KLES Dr.Prabhakar Kore Hospital and MRC,Advanced Physiotherapy Centre Orthopaedic Department Room number :18,Nehru nagar Belagavi -590010
KLES Dr.Prabhakar Kore Hospital and MRC,Advanced Physiotherapy Centre Orthopaedic Department Room number :18,Nehru nagar Belagavi -590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7892641910 |
| Fax |
|
| Email |
chandaragivandana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Peeyoosha Gurudut |
| Designation |
Professor and Head of Department |
| Affiliation |
Kaher Institute of Physiotherapy Belgaum |
| Address |
KLES Dr.Prabhakar Kore Hospital and MRC,Advanced Physiotherapy Centre Orthopaedic Department Room number :18,Nehru nagar Belagavi -590010
KLES Dr.Prabhakar Kore Hospital and MRC,Advanced Physiotherapy Centre Orthopaedic Department Room number :18,Nehru nagar Belagavi -590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeyooshagurudut@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Peeyoosha Gurudut |
| Designation |
Professor and Head of Department |
| Affiliation |
Kaher Institute of Physiotherapy Belgaum |
| Address |
KLES Dr.Prabhakar Kore Hospital and MRC,Advanced Physiotherapy Centre Orthopaedic Department Room number :18,Nehru nagar Belagavi -590010
KLES Dr.Prabhakar Kore Hospital and MRC,Advanced Physiotherapy Centre Orthopaedic Department Room number :18,Nehru nagar Belagavi -590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeyooshagurudut@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| kaher institude of physiotherapy nehru nagar belagavi 590010 |
|
|
Primary Sponsor
|
| Name |
Vandana Chandaragi |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Department room number:18 ,Nehru nagar,Belagavi-590010 |
| 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 |
| Vandana Chandaragi |
KLE Institute Of Physiotherapy ,Belagavi |
KLES Dr.Prabhakar Kore Hospital and MRC ,Advanced Physiotherapy Centre, Orthopaedic Department.
Room no:18,
Nehru nagar,
Belagavi,590010.
Belgaum
KARNATAKA |
7892641910
chandaragivandana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethical committee KLEU institute if physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, (2) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GRADED MOTOR IMAGERY |
6-Months Study Application Of Graded Motor Imagery In Individuals with Rotator Cuff Repair |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients who have undergone Rotator cuff repair surgery with post operative duration within 1 week.
2)Both male and female adults aged 40-65years of age
3)Subjects who reside in Belagavi city
4)Participants willing to participate and have signed informed consent
5)Participants who can comprehend the commands
|
|
| ExclusionCriteria |
| Details |
1)Patients with cognitive impairment and psychological disorders which might interfere their ability to follow Graded Motor Imagery protocol
2)Severe visual and hearing impairments.
3)Open wounds or active infections near surgical site
4)Participants with recent upper limb fractures, dislocations etc.
5)Patients with uncontrolled diabetes mellitus or other autoimmune disorders that could interfere with healing process will be excluded
6)Participants who have previously received treatment with graded motor imagery.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Range Of Motion-Shoulder joint
|
Range Of Motion-Shoulder joint-measure in degrees
Time Points:
pre assesment before surgery.
post intervention after surgery over three weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain-Numeric pain rating scale
Kinesiophobia-Tampa Scale of kinesiophobia
Functional status-Disability of arm,shoulder and hand |
Time Points:
pre assesment before surgery.
post intervention after surgery over three weeks
|
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/01/2025 |
| Date of Study Completion (India) |
16/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
16/07/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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 Effectiveness of Graded Motor Imagery(GMI) in improving recovery outcomes in individuals with post-operative rotator cuff repair. Rotator cuff injuries are common in adults aged 40–70 and often lead to pain, reduced range of motion (ROM), and functional limitations. Post-surgery complications like shoulder stiffness, kinesiophobia (fear of movement), and persistent pain can hinder recovery. GMI, a neuroplasticity-based therapeutic approach, is used to enhance rehabilitation by engaging brain motor networks through techniques like laterality recognition, motor imagery exercises, and mirror therapy. The study employs a pilot randomized controlled trial design to evaluate the impact of GMI on pain, ROM, kinesiophobia, and functional status compared to conventional therapy. By assessing outcomes over three weeks, the research aims to establish whether GMI can accelerate recovery and improve the quality of life for patients, addressing a gap in current post-operative physiotherapy practices. |