| CTRI Number |
CTRI/2025/08/093865 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find out whether Both arm training or single arm training has effects on improvement after stroke. The outcome is calculated by Activities of Daily living (FIM) and Action Research Arm test. |
|
Scientific Title of Study
|
Effects of Bilateral and Unilateral upper limb training on Dominant and Non Dominant Upper limb recovery After acute ischemic stroke a Randomized control 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 |
S Benedic Kingslin Suresh |
| Designation |
Research Scholar |
| Affiliation |
MGM Hospital |
| Address |
12, Vembuliamman Koil street,
West K.K Nagar,
Department of Physiotherapy
Meenakshi Academy of Higher Education and Research
Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
9841037003 |
| Fax |
|
| Email |
benedic_suresh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MP Pathasarathy |
| Designation |
Professor |
| Affiliation |
Meenakshi Medical College Hospital and Research Institute |
| Address |
Department of Orthopeadics,
Meenakshi Medical College Hospital and Research Institute,
Enathur,
Kanchipuram
Kancheepuram
TAMIL NADU
631552
India |
| Phone |
9894319014 |
| Fax |
|
| Email |
parthadr1986@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Benedic Kingslin Suresh |
| Designation |
Research Scholar |
| Affiliation |
MGM Hospital |
| Address |
12, Vembuliamman Koil street,
West K.K Nagar,
Department of Physiotherapy
Meenakshi Academy of Higher Education and Research
Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
9841037003 |
| Fax |
|
| Email |
benedic_suresh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| MGM Healthcare
No 72 Nelson Manickam Road Aminjikkarai
Chennai 600029 |
|
|
Primary Sponsor
|
| Name |
S Benedic Kingslin Suresh |
| Address |
No 72, Department of Rehabilitation Medicine,
MGM Healthcare
Nelson Manickam Road,
Aminjikarai,
Chennai 600029 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| S Benedic Kingslin Suresh |
MGM Hospital |
Department of Rehabilitation Medicine, No 72, Nelson Manickam Road,
Aminjikarai,
Chennai 600029
Chennai
TAMIL NADU |
9841037003
benedic_suresh@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM Institutional Ethics Committee |
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 |
| Intervention |
Bilateral arm training |
Total Duration 20 minutes per day, 100 minutes per week and 400 minutes per month. The intervention is for One month. Practiced identical tasks with each arm simultaneously. Training lasted 20 minutes a session 5 weekdays a week over 1 month in addition to usual therapy. Participants performed as many trials as possible in each session to a maximum of 30 trials of each task, a total of 120 trials per session.
Participants discharged home before the end of the intervention period continued training at home twice a week through supervised visits of 30 minutes in duration from the same therapists, in line with the usual discharge and follow up procedures.
Equipment and task protocols were standardized and portable. The program incorporated 4 core tasks typically found difficult by stroke patients;
Participants were asked
(1) To move a doweling peg 2cm in diameter by 4cm in height from tabletop to attach to the underside of a shelf placed at eye level
(2) To move a 7 cubic cm block from the table onto a shelf at shoulder height
(3) To grasp an empty glass, take to the mouth, and return to starting position and
(4) To point to targets raised 30cm from the table and positioned at midline, 40cm to the right, and 40cm to the left of midline |
| Comparator Agent |
Unilateral arm training |
Participants in the unilateral training group followed the same program as the bilateral training group but used the paretic upper limb only. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
74.00 Year(s) |
| Gender |
Both |
| Details |
1) Hemiplegia resulting from cerebrovascular disease,
2) No pain in either arm,
3) No cognitive or perceptive disorders limiting the ability to follow therapist directions,
4) Onset of stroke below six months before the study, and
5) Flexion and extension of the wrists and fingers of greater than equal to 15°. |
|
| ExclusionCriteria |
| Details |
1) Pain in the upper limb
2) Chronic stroke
3) Fractures and Deformities in Upper limb. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Action research arm test |
0 month, 3 month and 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional Independent measure |
0 month, 3 month and 6 month |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
08/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study
is a randomized, single blind, parallel group, single Centre trail comparing
the Effects of Bilateral and Unilateral upper limb training on Dominant and Non-Dominant
Upper Limb Recovery After Acute Ischemic Stroke. For 2 years in 70 patients.
Will be conducted in India. The primary outcome will be Action Research Arm
test and the Secondary outcome will be Functional Independent Measure. Both
Outcome measures will be assessed on 0 month, 3 months and 6 months. |