| CTRI Number |
CTRI/2023/05/053184 [Registered on: 29/05/2023] Trial Registered Prospectively |
| Last Modified On: |
04/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Mirror therapy for neglecting the paralyzed body part in Stroke |
|
Scientific Title of Study
|
Task-based and Magnified Mirror Therapy for Unilateral Spatial Neglect among Post-Stroke Subjects: A Randomized Controlled Trial
|
| Trial Acronym |
T-MAGUSN |
|
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 |
PDUNIPPD |
| Address |
Pt. DU National Institute for Persons with Physical Disabilities, 4 VD Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
kamalnarya@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamal Narayan Arya |
| Designation |
Lecturer (Occupational therapy) |
| Affiliation |
PDUNIPPD |
| Address |
Pt. DU National Institute for Persons with Physical Disabilities, 4 VD Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
kamalnarya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamal Narayan Arya |
| Designation |
Lecturer (Occupational therapy) |
| Affiliation |
PDUNIPPD |
| Address |
Pt. DU National Institute for Persons with Physical Disabilities, 4 VD Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
kamalnarya@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, New Delhi |
| Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities, New Delhi |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Indian Council of Medical Research, New Delhi |
| 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 National Institute for Persons with Physical Disabilities |
Neuro-Rehab Unit, Department of Occupational therapy
Central
DELHI |
9899897408
kamalnarya@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt. Dendayal Upadhyaya National Institute for Persons with Physical Disabilities |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control intervention |
In addition to the conventional motor rehabilitation, the control group will be provided following intervention for the USN rehabilitation for a dose match (2- hour) program –
•Mirror frame will be placed in front of the patient while he will be performing activities of daily living, ambulation and motor activities (unilateral and bilateral) in order to draw attention to the neglected side.
•Mid-line crossing activities – unilateral and bilateral
•Scanning, puzzle, trail making, drawing activities
|
| Intervention |
Task-based and MAGnified Mirror Therapy for Unilateral Spatial Neglect (T-MAGUSN) |
The experimental intervention will comprise of the following components -
1.Task-based upper limb mirror therapy (20 minutes x 40 sessions)
2.Task-based lower limb mirror therapy (20 minutes x 40 sessions)
3.Magnified mirror therapy (10 minutes x 40 sessions)
4.Task-based parasagital plane visual feedback mirror therapy (10 minutes x 40 sessions)
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. First episode of unilateral stroke (as defined by WHO)2. Ischemic or hemorrhagic stroke
3. 1 to 36 months after the stroke onset
4. Hemiparesis (right or left) (as assessed by Fugl-Meyer assessment38 upper extremity subsection: 0 to 66)
5. USN (defined as an asymmetry between the Letter cancellation task omissions in the contralesional (left) and ipsilesional (right) visual field of at least 2 letters)
6. Normal visual abilities (with or without glasses)
7. Muscle tone: Modified Ashworth scale 1 to 2
|
|
| ExclusionCriteria |
| Details |
1.Receptive communication or other language disorder (which could interfere with the assessment and treatment process)
2. Severe other cognitive impairment (MMSE ≤ 17)
3. Homonymous Hemianopia.
4. Contractures and deformities of hand / finger
5. Use of hand splinting or orthosis
6. Complex regional pain syndrome
7. Concomitant medical illness
8. Cardiovascular instability: resting systolic blood pressure >200mmHg and resting diastolic blood pressure >100 mmHg
9. Pregnancy
10. Renal infection or failure
11. Severe depression (Beck depression inventory > 30)
|
|
|
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
|
Baseline, At 8 week (Post intervention), At 12 week (Follow-up)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Catherine Bergego Scale
2.Berg Balance Scale
3.Functionl Ambulation Category
4. Modified Rankin Scale |
Baseline, 8- Weeks Postintervention, 12-Weeks Follow-up |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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 2 |
|
Date of First Enrollment (India)
|
05/06/2023 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The proposed study would lead to a development of novel rehabilitation protocol for post stroke subjects with unilateral spatial neglect. The favorable change in the neglect may also enhance the motor recovery, especially the upper limb. The change would reduce the impact of cognitive and functional disabilities and enhancing the quality of life. |