| CTRI Number |
CTRI/2024/11/076332 [Registered on: 06/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational Therapy ] |
| Study Design |
Other |
|
Public Title of Study
|
Effects of mirror therapy on bilateral task practice in patients with stroke |
|
Scientific Title of Study
|
Assessing the Priming effects of Mirror Visual Feedback on Bilateral Task Practice in patients with Stroke : A Quasi Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ritu Prabhunath Ram |
| Designation |
Second Year Master of Occupational Therapy in Neuroscience |
| Affiliation |
Goa Medical College |
| Address |
Goa Medical College, Department of Medicine, Department of Neurology,OPD 17, Bambolim-Goa, India
North Goa
GOA
403202
India |
| Phone |
7038658783 |
| Fax |
|
| Email |
ramritu091@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Vajaratkar |
| Designation |
Associate Professor in Occupational Therapy |
| Affiliation |
Goa Medical College |
| Address |
Department of Orthopedics, Goa Medical College, Bambolim
North Goa
GOA
403202
India |
| Phone |
9730948392 |
| Fax |
|
| Email |
vivekvajaratkar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivek Vajaratkar |
| Designation |
Associate Professor in Occupational Therapy |
| Affiliation |
Goa Medical College |
| Address |
Department of Orthopedics, Goa Medical College, Bambolim
North Goa
GOA
403202
India |
| Phone |
9730948392 |
| Fax |
|
| Email |
vivekvajaratkar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Goa Medical College and Hospital , Department of Medicine and Department of Neurology ,OPD 17, Bambolim-Goa, India
Pin code-403202 |
|
|
Primary Sponsor
|
| Name |
Dr Ritu Prabhunath Ram |
| Address |
Goa Medical College , Department of Medicine Department of Neurology OPD 17 Bambolim-Goa India
403202 |
| 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 |
| Dr Ritu Prabhunath Ram |
Goa Medical College and Hospital |
Department of Medicine Department of Neurology OPD 17 Bambolim Goa India
North Goa
GOA |
7038658783
ramritu091@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Lois James Samuel |
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 |
Bilateral Arm Training |
The hospital-based BAT protocol was similar to that of MT, but the mirror box was not
provided. The participants were asked to symmetrically move both arms as
simultaneously as possible. |
| Intervention |
Mirror Therapy |
The hospital-based MT protocol included mirror box training for 45 minutes and
functional training for 45 minutes. After 10 minutes of warm-up exercises for the
affected arm, including stretching and a passive range of motion exercises, a portable
mirror box (48 × 36 × 36 cm3) will be placed in the midsagittal plane of each
participant. The affected arm will be positioned behind the mirror. The movements of
the unaffected arm in front of the mirror will be reflected as if the affected side was
being moved. During the mirror box training, the participants will be guided to gaze at
the mirrored image to allow them to imagine that the reflection is their affected arm
performing the activities and to move both arms in symmetric patterns as
simultaneously as possible. The activities will consist of 10 minutes of non-task
oriented movements, such as forearm pronation/supination or finger flexion/extension,
and 35 minutes of task-oriented activities, such as picking up the handset from the
phone, picking up items and putting them in the box, or other functional tasks involved
in daily activities. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Sustained unilateral ischemic or hemorrhagic stroke
2. Between ages of 30 and 80
3. With mild to moderate motor impairment (total Fugl-Meyer assessment upper
extremity score between 18 and 55)
4. Able to follow instructions |
|
| ExclusionCriteria |
| Details |
1. Severe spasticity (Modified Ashworth Score 3 or greater)
2. Cognitive deficits
3. Hemi spatial neglect |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Fugl Meyer Assessment – Upper Extremity
2.Motor Activity Log
3.stroke Impact Scale |
1.4 weeks
2.4 weeks
3.4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Chedoke Arm and Hand Activity Inventory |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
18/11/2024 |
| 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="0"
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
|
Mirror visual feedback (MVF) is a technique used in stroke patients rehabilitation to improve their motor recovery. Bilateral Arm Training has emerged as an
approach that leads to positive outcomes in addressing upper extremity paresis after stroke.
BAT is based on motor learning principles, the aim of overcoming learned non-use and relative
inactivity but also includes the use of the non-paretic arm The purpose of study is to investigate effect of early visual priming using mirror visual feedback in recovery of functional status of the patients with stroke admitted in tertiary care hospital.Study will be conducted using Quasi-experimental study design.The study will be conducted in the patients which will be admitted in Goa Medical College and Hospital. Outcome measures used will be Fugl meyer upper extremity assessment , Motor activity log, stroke impact scale will be measured at baseline and after 4 weeks of intervention. |