FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/075512 [Registered on: 18/10/2024] Trial Registered Prospectively
Last Modified On: 15/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Developing and Testing a Hand Assessment Tool Using a Robot for Stroke Patients 
Scientific Title of Study   Development and Validation of a Hand Assessment Battery Using an Indigenous End-effector Robot System for People with Stroke 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nistara Singh Chawla 
Designation  PhD Scholar 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy
Manipal College of Health Professions, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India 
Phone  08146296621  
Fax    
Email  nistarachawla@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr John Solomon M 
Designation  Additional Professor and Head 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy,
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India 
Phone  9945670671  
Fax    
Email  john.solomon@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Manikandan N 
Designation  Additional Professor  
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy
Manipal College of Health Professions, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India 
Phone  9886898064  
Fax    
Email  mani.kandan@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India – 576104 
 
Primary Sponsor  
Name  Nistara Singh Chawla 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Udupi, Karnataka, India,576104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr TMA Pai Scholarship  Manipal Academy of Higher Education 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr John Solomon M  Kasturba Hospital  Neuromotor Control Room 3rd Floor department of physiotherapy
Udupi
KARNATAKA 		 09945670671

john.solomon@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I63||Cerebral infarction, (2) ICD-10 Condition: I60-I69||Cerebrovascular diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Sensorimotor Assessment  45 mins to 1 hour in duration per session- 5 sessions 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Diagnosis of stroke confirmed by a neurologist; Individuals with ischaemic or haemorrhagic stroke; Ability to follow commands (MOCA more than 24) 
 
ExclusionCriteria 
Details  Pain in the hand equivalent or more than 3 as scored on NPRS; Spasticity in the hand of more than Grade 1+ as measured on MAS; Visual, perceptual issues, global and Wernicke’s aphasia; Premorbid hand deficits and hand deformities; Comorbid neurological/ psychiatric conditions (Parkinson disease, psychosis, etc); Any condition that precludes the opening of hand or prevent attachment of Robot to hand 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Validity, Reliability, Sensitivity, Specificity, Responsivenes, MCID  once every week for 4 weeks and then after 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   01/04/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
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 -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  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 (Others) -  Undecided

  6. For how long will this data be available start date provided 01-03-2026 and end date provided 01-03-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A robotic system will be used for the purpose of assessment of upper extremity of individuals with stroke. The individuals would be seated comfortably and explained about the procedure. Sensory, motor and kinematic assessments will be performed. The patients will be assessed at 5 different time points for the evaluating the psychometric properties of these assessments. Validity, reliability, sensitivity, specificity, MCID and responsiveness to change will be evaluated. The values of the robotic assessments will be compared to those measured with electromagnetic trackers for reference. 
Close