| CTRI Number |
CTRI/2025/07/090341 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Other (Specify) [occupational therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Graded Motor Imagery with Conventional Occupational Therapy in patients with Supracondylar humerus fracture. |
|
Scientific Title of Study
|
Effect of Graded Motor Imagery with Conventional Occupational Therapy on Pain and Upper limb functionality in patients with Supracondylar humerus fracture. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prachi Mehta |
| Designation |
Post graduate student in Occupational Therapy |
| Affiliation |
OT Training School and Centre LTMMC and GH |
| Address |
OT Training School and Centre LTMMC Dr Babasaheb Ambedkar Road
Mortuary building 5th floor OPD 23
Sion
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
8425845400 |
| Fax |
|
| Email |
prachi.mehta1812@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Yeradkar |
| Designation |
Associate Professor and Incharge OT Training School and Centre LTMMC |
| Affiliation |
OT School and Centre LTMMC and GH |
| Address |
OT Training School and Centre LTMMC Dr Babasaheb Ambedkar Road
Mortuary building 5th floor OPD 23
Sion
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
9820954156 |
| Fax |
|
| Email |
otrashmi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Yeradkar |
| Designation |
Associate Professor and Incharge OT Training School and Centre LTMMC |
| Affiliation |
OT School and Centre LTMMC and GH |
| Address |
OT Training School and Centre LTMMC Dr Babasaheb Ambedkar Road
Mortuary building 5th floor OPD 23
Sion
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
9820954156 |
| Fax |
|
| Email |
otrashmi@gmail.com |
|
|
Source of Monetary or Material Support
|
| OT training school and centre LTMMC and GH |
|
|
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 Prachi Mehta |
LTMMC and GH Sion |
OT Training School and Centre LTMMC Dr Babasaheb Ambedkar Road
Mortuary building
5th floor OPD 23
Sion
Mumbai (Suburban)
MAHARASHTRA |
08425845400
prachi.mehta1812@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee and Human Research Lokmanya Tilak Municipal Medical College and General Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M848||Other disorders of continuity of bone, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Occupational therapy to Control group |
The intervention comprises of 8 weeks Patient will be followed up twice in a week which consists of 16 sessions. The session will be of 45 minutes The patient will be assessed during baseline at the end of 3 weeks and at the end of 8 weeks Pain and Grasp strength will be assessed at basline and at the end of 8 weeks Range of motion and Upper limb functionality will be assessed at the end of 3 weeks and at the end of 8 weeks Once the patient is recruited in control group through lottery method active finger and shoulder exercises are given for 3 weeks proceeded by active and active assisted elbow range of motion exercises till 8 weeks |
| Intervention |
Graded motor imagery |
The intervention comprises of 8 weeks Patient will be followed up twice in a week which consists of 16 sessions. The session will be of 45 minutes The patient will be assessed during baseline at the end of 3 weeks and at the end of 8 weeks Pain and Grasp strength will be assessed at basline and at the end of 8 weeks Range of motion and Upper limb functionality will be assessed at the end of 3 weeks and at the end of 8 weeks Once the patient gets recruited in intervention group through lottery method he will be screened on TVPS and VSMS From baseline the intervention will begin which is a complex series of treatments including implicit motor imagery explicit motor imagery and mirror therapy |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Patients with right and left dominance
All types of supracondylar fracture on gartland classification
1 week post conservative and surgical management
Children scoring age appropriate on specific subtests of Test of Visual Perceptual skills 3rd edition
Children having mental age as per their chronological age as measured on Vineland Social Maturity Scale
Patients prescribed with and without splint |
|
| ExclusionCriteria |
| Details |
Nuerovascular complication
Any neurological condition
Visual impairment |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Pain on Visual Analogue Scale and
2 Upper limb functionality on Patient Rated Elbow Evaluation
3 Range of motion of affected Elbow on Goniometer
4 Grasp strength of affected hand on Jamar dynamometer |
Visual Analogue scale at baseline and at the end of 8 weeks
Patient Rated Elbow Evaluation at the end of 3 weeks and at the end of 8 weeks
Range of Motion of affected elbow will be measured using a goniometer at the end of 3 weeks and at the end of 8 weeks
Grasp strength of affected hand using Jamar dynamometer will be assessed at the baseline and at the end of 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
25/07/2025 |
| 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 Applicable |
| 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
|
Supracondylar humerus fractures are common in children mainly between ages 5 to 6 years caused by fall on an outstretched hand It leads to complications like pain swelling cubitus varus deformity limited range of motion A newer top-down cortical reorganization approach involving Implicit Motor Imagery which includes laterality recognition Explicit Motor Imagery which is imagining movements and Mirror Therapy will be used in intervention It aims to reduce pain and improve function This research aims to evaluate if GMI combined with conventional Occupational Therapy is more effective than OT alone in improving Pain Elbow range of motion Grip strength Upper limb functionality It is a comparative study conducted in a tertiary care hospital over a period of 1 year 28 children aged between 6 to17 years randomized via lottery will be enrolled for the study They will be grouped in 2 groups Group A Conventional OT Group B GMI with Conventional OT Test of Visual Perception skills 3rd edition and Vineland Social Maturity Scale will be used to screen children after being enrolled in interventional group Outcome Measures like Pain ROM using Goniometer Grip Strength using Jamar Dynamometer and Functionality using Patient Rated Elbow Evaluation (PREE) will be assessed Intervention will continue for a period of 8 weeks The study objectives are to assess and compare pre and post values of pain ROM grip strength and function It is used to examine effectiveness of GMI in children with SCH Expected Outcome of this study will be that GMI with OT may reduce pain more effectively improve elbow ROM and grip strength enhance upper limb function motivate patients to continue therapy |