| CTRI Number |
CTRI/2020/08/027021 [Registered on: 07/08/2020] Trial Registered Prospectively |
| Last Modified On: |
02/09/2021 |
| 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
|
Benefits of hand activity training to improve arm use in stroke patients. |
|
Scientific Title of Study
|
Effect of Enhanced Bilateral Hand Activity Training on upper limb functional recovery in people with stroke - A randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alexander G |
| Designation |
PhD Research Scholar |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy,
Manipal College of Health Professions,
Manipal Hospital,
HAL Airport Road,
Bangalore.
Bangalore
KARNATAKA
560017
India |
| Phone |
7039745648 |
| Fax |
|
| Email |
alexdavid306@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Alexander G |
| Designation |
PhD Research Scholar |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy,
Manipal College of Health Professions,
Manipal Hospital,
HAL Airport Road,
Bangalore.
Bangalore
KARNATAKA
560017
India |
| Phone |
7039745648 |
| Fax |
|
| Email |
alexdavid306@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karthik Babu S |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy,
Manipal College of Health Professions,
Manipal Hospital,
HAL Airport Road,
Bangalore.
Bangalore
KARNATAKA
560017
India |
| Phone |
9902338198 |
| Fax |
|
| Email |
karthikbabu78@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions, Department of Physiotherapy, Manipal Hospital, HAL Airport Road, Bangalore. |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy,
Manipal College of Health Professions,
Manipal Hospital,
HAL Airport Road,
Bangalore. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Alexander |
Manipal Hospital |
Department of Physiotherapy,
6, Basement second floor
Bangalore
KARNATAKA |
7039745648
alexdavid306@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Enhanced Bilateral Hand Arm Training group |
Training intensity - One hour session per day, 3 days a week for 8 weeks.
Follow-up - 12 weeks follow-up. |
| Comparator Agent |
Standard Physiotherapy Training group. |
Training intensity - One hour session per day, 3 days a week for 8 weeks.
Follow-up - 12 weeks follow-up. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. First episode of unilateral supratentorial stroke.
2. Subacute and chronic (>1 m).
3. Montreal Cognitive Assessment >26/30.
4. Low to moderate stroke (NIHSS <15).
5. Active range of movement at least in degrees and preferred to repeat 3 times in 1 minute. Shoulder Flexion/Abduction (45), Elbow Extension (20), Wrist Extension (10), Thumb Extension/Abduction (10) and any two fingers Extension (10). |
|
| ExclusionCriteria |
| Details |
1. Currently participation in other pharmacologic or physical therapy intervention studies.
2. Modified Ashworth scale (> 2) of upper limb musculature.
3. Administered of BOTOX within 3 months.
4. Unstable medical condition
5. Cardio-respiratory complications that limits exercises and hand activity.
6. Shoulder subluxation of grade 2 and above.
7. Severe shoulder and hand pain >7/10 on numerical pain rating scale.
8. Musculoskeletal complications in past 3 months that limits the hand activity.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
ABILHAND
|
3 time points
Baseline, 8 weeks post treatment and 12 weeks follow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Wolf Motor Function Test,
Motor Activity Log,
Fugl-Meyer Assessment upper limb.
|
3 time points
Baseline, 8 weeks post treatment and 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
|
N/A |
|
Date of First Enrollment (India)
|
17/08/2020 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study objective is to compare the effect of Enhanced Bilateral Hand Activity Training and standard physiotherapy training on upper limb functional recovery in people with stroke. |