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CTRI Number  CTRI/2020/08/027021 [Registered on: 07/08/2020] Trial Registered Prospectively
Last Modified On: 03/11/2025
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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)= "103"
Final Enrollment numbers achieved (India)="103" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/08/2020 
Date of Study Completion (India) 23/11/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
This study aimed to compare the effects of EBHAT with standard physiotherapy training (SPT) on upper
limb functional recovery in stroke survivors. 
Between September 2020 and November 2023, 103 participants were enrolled (EBHAT n=51, SPT n=52). After 8 weeks, the EBHAT group showed greater improvement in
ABILHAND scores than SPT (mean difference 3·31 [95% CI 2·65–3·97]; p&lt;0·0001), and gains were maintained at 20 weeks (3·77 [3·10–4·43]; p&lt;0·0001). Significant between-group differences favouring EBHAT were also observed for MAL, WMFT, and FMA-UE outcomes at both post-intervention and follow-up. No serious adverse events occurred.
 
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