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CTRI Number  CTRI/2017/04/008426 [Registered on: 27/04/2017] Trial Registered Prospectively
Last Modified On: 24/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Benefits of Arm-Hand Practice with Splinting of Wrist on Hand Function in Stroke 
Scientific Title of Study   Effect of Bimanual Arm-Hand Training with Dynamic Dorsal Splint on Hand Function in 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  Ms Archana Raghu 
Designation  Masters of Physiotherapy(MPT) Student 
Affiliation  Manipal University 
Address  Department of Physiotherapy, School of Allied Health Sciences, Manipal University Manipal Hospital, HAL Airport Road, Bangalore.

Bangalore
KARNATAKA
560017
India 
Phone  9036115127  
Fax    
Email  archanaraghu2009@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S Karthikbabu 
Designation  Assoc. Professor 
Affiliation  Manipal University 
Address  Department of Physiotherapy, School of Allied Health Sciences, Manipal University Manipal Hospital, HAL Airport Road, Bangalore.

Bangalore
KARNATAKA
560017
India 
Phone  9902338198  
Fax    
Email  karthikbabu78@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mrs Divya Mohan 
Designation  Asst. Professor- Senior Scale 
Affiliation  Manipal University 
Address  Department of Physiotherapy, School of Allied Health Sciences, Manipal University, Manipal Hospital, HAL Airport Road, Bangalore.

Bangalore
KARNATAKA
560017
India 
Phone  9886794027  
Fax    
Email  dimspt2002@yahoo.co.in  
 
Source of Monetary or Material Support  
School of Allied Health Sciences, Manipal University, Manipal Hospital, HAL Airport Road, Bangalore.  
 
Primary Sponsor  
Name  SOAHS Manipal University 
Address  Department of Physiotherapy, School of Allied Health Sciences, Manipal Hospital, 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 
Archana Raghu  Manipal Hospital  Physiotherapy, School of Allied Health Sciences, HAL Airport Road.
Bangalore
KARNATAKA 		 9036115127

archanaraghu2009@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Reseach Committee of SOAHS, Maipal University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Stroke patients with hand dysfunction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bimanual Arm-Hand Training with Dynamic Dorsal Splint  Tactile exploration of hand tasks and bimanual arm-hand physical activity with the use of dynamic dorsal splint. Exercise session lasted one hour a day, 3 days a week over 6 weeks duration. 
Comparator Agent  Conventional Physiotherapy  Physical therapy exercises for hand and arm that involves tone modulation, stretches, muscle activity and weight bearing of involved upper limb. Exercise session lasted one hour a day, 3 days a week over 6 weeks duration.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1)First episode of unilateral stroke with hemiparesis 2)Medically stable patients
3)Patients able to follow simple verbal instruction
4)Patients scoring 0 to 2 on Modified Ashworth Scale of Spasticity
5)Brunnstrom stage of recovery 3 for hand and 3+ for arm
 
 
ExclusionCriteria 
Details  1)Dementia
2)Perceptual dysfunction
3)Incoordination due to infratentorial lesion
4)History of upper limb fracture in the past 6 months
5)Pusher’s syndrome
6)Unilateral neglect
7)Shoulder hand syndrome 
 
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 
1) Wolf Motor Function Test
 		 Baseline
6 weeks post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
1) Action Research Arm Test
2) Hand Held Dynamometer(Digital) 		 Baseline
6 weeks post intervention  
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   29/04/2017 
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="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   In daily activities, the use of hand post stroke depends on the amount of sensory exporation of hand. In patients with spastic hand, the hand functioning is limited due to difficult in opening hand and the volar spinting of wrist and hand. Dynamic dorsal splint might allow for extensive use of hand tasks. Earlier in a pilot work, we designed a dynamic dorsal splint and tested for its applicability in patients post stroke that permits the tactile exploration of hand. In the present RCT, we attempt to examine the effects of bimanual arm-hand training with the dynamic dorsal spint on hand functioning in people with stroke.    
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