| CTRI Number |
CTRI/2015/07/006006 [Registered on: 15/07/2015] Trial Registered Prospectively |
| Last Modified On: |
23/04/2022 |
| 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
|
Mirror exercise in paralysis |
|
Scientific Title of Study
|
Role of long term task-based mirror therapy in inducing motor recovery in post stroke hemiparesis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kamal Narayan Arya |
| Designation |
Lecturer, occupational therapy |
| Affiliation |
Pt. Deendayal Upadhyaya Intitute for the Physically Handicapped |
| Address |
Pt. Deendayal Upadhyaya Institute for the Physically Handicapped, Room No. 24, Department of Occupational Therapy, 4 Vishnu Digamber Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
09899897408 |
| Fax |
|
| Email |
kamalnarya@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamal Narayan Arya |
| Designation |
Lecturer, occupational therapy |
| Affiliation |
Pt. Deendayal Upadhyaya Intitute for the Physically Handicapped |
| Address |
Pt. Deendayal Upadhyaya Institute for the Physically Handicapped, Room no. 24, Department of Occupational Therapy, 4 Vishnu Digamber Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
09899897408 |
| Fax |
|
| Email |
kamalnarya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamal Narayan Arya |
| Designation |
Lecturer, occupational therapy |
| Affiliation |
Pt. Deendayal Upadhyaya Intitute for the Physically Handicapped |
| Address |
Pt. Deendayal Upadhyaya Institute for the Physically Handicapped, Room no. 24, Department of Occupational Therapy, 4 Vishnu Digamber Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
09899897408 |
| Fax |
|
| Email |
kamalnarya@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, Ansari Nagar, New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Ansari Nagar, New Delhi - 110029 |
| Type of Sponsor |
Government funding agency |
|
|
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 Kamal Narayan Arya |
Pt. Deendayal Upadhyaya Institute for the Physically Handicapped |
Room no. 24, Department of Occupational Therapy, 4 Vishnu Digamber Marg, New Delhi
Central
DELHI |
09899897408
kamalnarya@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDUIPH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Post Stroke Hemiparetic Subjects, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional management |
The Control group will receive conventional occupational therapy program for the entire session while the experimental group would undergo the conventional therapy and TBMT for 45 minutes and 30 minutes respectively. Brunnstrom and Bobath approaches will be given as for the conventional program. These approaches would be provided using various activities such as blocks, therapeutic ball, pyramids, pegs, clay, and paddle cycle |
| Intervention |
Task-based mirror therapy |
TBMT protocol will be provided by a wooden mirror box would be made. However, the size would be modified (24x18x14 inches) to allow adequate vision with correct posture for taller subjects. The box will be painted in black color both from out- and inside to create maximum illusion. Various objects will be utilized to provide TBMT such as duster, a glass, wooden blocks of different size and shape, a spongy ball, paper clips, beads, coins, clay etc. The subject will be made to sit close to a table on which the mirror box would be placed vertically at the mid sternum level. The less-affected upper limb will be placed in front of the mirror to visualize the image while the affected limb will be placed inside the mirror box. Subject can perceive the image of the less-affected limb as the affected limb. By observing the image of the less-affected upper extremity as a projection over the affected limb, an illusion will be created (figure 1). The subject will be instructed to remove any rings / bangle / wrist-watch from the less-affected upper limb. The session would comprise practice of the less-affected elbow, forearm, wrist and ï¬nger movements using various tasks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
•Single unilateral stroke with hemiparesis
•> 24 weeks poststroke
•Able to understand instruction
•Brunnstrom recovery stage of arm (BRS-A) 2 or above
•Normal visual abilities
|
|
| ExclusionCriteria |
| Details |
•Receptive communication disorder
•Uncontrolled systemic or cardiovascular disease
•Multiple strokes
•Cognitive / perceptual deficit
•Shoulder subluxation
|
|
|
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 |
| Fugl-Meyer assessment (FMA) |
at 0 day and at 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Barthel Index (BI)
Modified Rankin Scale (mRS) |
at 0 day and at 6 month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
01/12/2015 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NOne |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To develop long term task-based mirror therapy program for post stroke hemiparetic subjects. To determine the effectiveness of the program on motor and functional recovery of the subjects |