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CTRI Number  CTRI/2024/05/067363 [Registered on: 15/05/2024] Trial Registered Prospectively
Last Modified On: 13/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Testing if a device that provides arm weight support is usable by stroke survivors. 
Scientific Title of Study   Usability Evaluation of Motorized Arm Support (MARS) for Robot-Assisted Upper-Limb Training 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sivakumar Balasubramanian 
Designation  Professor and Head, Department of Bioengineering 
Affiliation  Christian Medical College Vellore 
Address  Department of Bioengineering Christian Medical College Vellore, Bagayam, Vellore Tamil Nadu, India

Vellore
TAMIL NADU
632002
India 
Phone  04162285098  
Fax    
Email  siva82kb@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sivakumar Balasubramanian 
Designation  Professor and Head, Department of Bioengineering 
Affiliation  Christian Medical College Vellore 
Address  Department of Bioengineering Christian Medical College Vellore, Bagayam, Vellore Tamil Nadu, India


TAMIL NADU
632002
India 
Phone  04162285098  
Fax    
Email  siva82kb@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sivakumar Balasubramanian 
Designation  Professor and Head, Department of Bioengineering 
Affiliation  Christian Medical College Vellore 
Address  Department of Bioengineering Christian Medical College Vellore, Bagayam, Vellore Tamil Nadu, India


TAMIL NADU
632002
India 
Phone  04162285098  
Fax    
Email  siva82kb@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Fluid Research Grant, Christian Medical College, Bagayam, Vellore, Tamil Nadu, India. PIN - 632002. 
 
Primary Sponsor  
Name  Christian Medical College Vellore 
Address  IDA Scudder Rd, Vellore, Tamil Nadu 632004 
Type of Sponsor  Private medical college 
 
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 
Dr Sivakumar Balasubramanian  Christian Medical College Vellore  Room no. 15, B-Block, 4th Floor, Department of Neurological Sciences, Christian Medical College Ranipet Campus, Ratnagiri Kilminnal, Tamil Nadu, India, Pin – 632517.
Vellore
TAMIL NADU 
04162285098

siva82kb@cmcvellore.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Silver (Research and Ethics Committee) of the Christian Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G00-G99||Diseases of the nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Stroke Survivors  30 stroke survivors prescribed for upper limb rehabilitation use the device for two sessions and provide feedback regarding the usability of the device with System Usability Scale. The total duration of the intervention is two hours (one hour/session) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Stroke survivor prescribed for upper limb therapy.
MoCA greater than 26/30
Minimum 10 cm voluntary movement with weight support from MARS
 
 
ExclusionCriteria 
Details  Shoulder subluxation greater than 0 by fingerbreadth palpation method
Pain in shoulder/elbow joints, visual analogue scale – VIS greater than 3/10
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
System Usability Scale  After a day or within a week from enrolment. 
 
Secondary Outcome  
Outcome  TimePoints 
Intrinsic Motivation Inventory (IMI)  After two therapy sessions 
Fugl Meyer Assessment  Baseline 
Box and Block Test  Baseline 
Work Area with 0%, 50% and 100% weight support  Baseline 
Grip strength with 0%, 50% and 100% weight support  Baseline 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/06/2024 
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="0"
Months="6"
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 - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [siva82kb@cmcvellore.ac.in].

  6. For how long will this data be available start date provided 01-10-2025 and end date provided 01-07-2029?
    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 - NIL
Brief Summary  

Injury to the brain caused by Stroke often results in weakness in the arm, which leads to difficulty in performing activities of daily living. It is possible to regain these functions by high-intensity therapy. One of the important techniques used in therapy is providing adaptive arm weight support. Existing passive devices for weight support, also used at home, are simple and inexpensive but do not have sensors that could make therapy fun and engaging through the concept of therapy by games. In addition, these devices are unable to automatically adapt weight support as the user recovers ability. Rehabilitation robots, on the other hand, address all these problems but are very expensive and complex for home settings. Thus, a simple, compact device is needed that enhances motivation through therapy by games with the potential for home therapy. Motorized Arm Support (MARS) is such a device being developed to satisfy these conditions. An important step in the development of the device after the technical developments is obtaining feedback about the device’s usability for performing different types of arm training from clinicians, therapists, and stroke survivors and making suitable modifications to the device.

 

Objectives

To understand clinical expectations of a rehabilitation robot that provides arm weight support from clinicians and stroke survivors.

 

Methods:

 

After the preliminary version of MARS is developed, it is shown to clinicians to understand the clinical usefulness of its features (Part 1). Suggestions are also obtained for new features that could be added to MARS. Based on the feedback, design modifications are made to the device and usability is evaluated using the system usability scale by testing the device with clinicians (Part 2a) and stroke survivors (Part 2b). The following section discuss Part 2b of the usability study with stroke survivors

Stroke survivors with weakness in the arm who:

a.      are above 18 years of age

b.     can understand instructions

c.      could perform small movements with robot support

are included in the study.

Patients with problems in the shoulder, such as pain, are excluded from the study. A therapist performs baseline assessments on stroke survivors, such as the Fugl-Meyer Assessment (FMA), and the Box and Block Test (BBT), to understand the impact of Stroke. Horizontal work area and grip strength are also measured to understand the usefulness of arm weight support in increasing the range of motion and grip strength, respectively. Clinicians and stroke survivors evaluate the usability of MARS using the System Usability Scale. Intervention includes moving the arm to play games and performing ADL activities in virtual or real life with arm weight support provided by the robot. Hand grasp is also trained for subjects with hand functions.

 
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