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CTRI Number  CTRI/2021/04/032595 [Registered on: 07/04/2021] Trial Registered Prospectively
Last Modified On: 13/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Relationship between arm and hand activities in stroke patients 
Scientific Title of Study   Relationship between upper extremity motor function and bimanual activities of daily life in patients with stroke. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhigna H S 
Designation  Postgraduate 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal Hospital HAL Airport Road

Bangalore
KARNATAKA
560017
India 
Phone  9972299097  
Fax    
Email  hsabhigna2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Karthik Babu S 
Designation  Associate Profesor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal Hospital HAL Airport Road

Bangalore
KARNATAKA
560017
India 
Phone  9902338198  
Fax    
Email  karthikbabu78@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pratiksha T Rao 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal Hospital HAL Airport Road

Bangalore
KARNATAKA
56017
India 
Phone  9538124416  
Fax    
Email  pratiksha.rao@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions  
 
Primary Sponsor  
Name  Manipal College of Health Professions  
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal Hospitals, 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 
Abhigna H S  Manipal Hospital  Department of Physiotherapy, Room number-2, Basement floor, HAL Airport Road. Bangalore KARNATAKA
Bangalore
KARNATAKA 		 9972299097

hsabhigna2@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: I688||Other cerebrovascular disorders indiseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Participants with first ever stroke (ischemic/hemorrhagic)
2.Both sexes of age 18 to 70 years
3.Medical stability
4.Subacute and chronic stroke patients
 
 
ExclusionCriteria 
Details  1.Patients with visual field defects
2.Patients with peripheral vestibular disorder
3.Fracture or surgery of upper extremity within 4-month.
4.Any neuromuscular disorder/ disease that affected both upper extremities.

Cognitive impairment (MoCA score < 24)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Fugl-Meyer scale
2. ABILHAND scale 		 Two crossectional time points 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
Final Enrollment numbers achieved (Total)= "65"
Final Enrollment numbers achieved (India)="65" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/04/2021 
Date of Study Completion (India) 31/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [hsabhigna2@gmail.com].

  6. For how long will this data be available start date provided 02-06-2022 and end date provided 02-06-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - None
Brief Summary
Modification(s)  
The objective of the study is to determine the relationship between motor functioning of upper extremity and bimanual activities using two standardized scales namely Fugl-Meyer for motor functioning and ABILHAND for bimanual activities. Also,to determine the factors affecting bimanual tasks. The motor function of upper limb post-stroke had a strong correlation with bimanual activities. WMFT score and MAL score (partical R2=0.599)were the critical factors affecting bimanual tesks.                   
 
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