| 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
|
|
|
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
|
|
|
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
- 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).
- 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
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [siva82kb@cmcvellore.ac.in].
- 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.
- 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. |