| CTRI Number |
CTRI/2026/02/105024 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Designing and Testing a System to Measure Voluntary Movement in People After Stroke |
|
Scientific Title of Study
|
Design, Development and Evaluation of Voluntary Motor Assessment System (VOMAS) for individuals with stroke |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GokulSworna |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gokul Krishnan S |
| Designation |
PG Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and research |
| Address |
4th Floor Vidya Sudha Building Sri Ramachandra Faculty of Occupational Therapy Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) No 1 Ramachandra Nagar Porur Chennai Tamil Nadu 600116 India Chennai TAMIL NADU 600116
4th Floor Vidya Sudha Building Sri Ramachandra Faculty of Occupational Therapy Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) No 1 Ramachandra Nagar Porur Chennai Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9074635388 |
| Fax |
|
| Email |
gokulmotn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Loganathan S |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and research |
| Address |
4th Floor Vidya Sudha Building Sri Ramachandra Faculty of Occupational Therapy Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) No 1 Ramachandra Nagar Porur Chennai Tamil Nadu 600116
4th Floor Vidya Sudha Building Sri Ramachandra Faculty of Occupational Therapy Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) No 1 Ramachandra Nagar Porur Chennai Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841958099 |
| Fax |
|
| Email |
loganathanot@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Loganathan S |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and research |
| Address |
4th Floor Vidya Sudha Building Sri Ramachandra Faculty of Occupational Therapy Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) No 1 Ramachandra Nagar Porur Chennai Tamil Nadu 600116
4th Floor Vidya Sudha Building Sri Ramachandra Faculty of Occupational Therapy Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) No 1 Ramachandra Nagar Porur Chennai Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841958099 |
| Fax |
|
| Email |
loganathanot@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Gokul Krishnan S |
| Address |
No 1 Ramachandra Nagar porur Chennai 600116 tamilnadu India |
| Type of Sponsor |
Other [Self Funding] |
|
|
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 Gokul Krishnan S |
Sri Ramachandra institute of higher education and research |
No 1 Ramachandra nagar porur chennai 600116 Tamilnadu India
No 1 Ramachandra nagar porur chennai 600116 Tamilnadu India
Chennai
TAMIL NADU |
09074635388
gokulmotn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| instituitional ethics committee SRIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Participants must know either Tamil or English.
This study will include both male and female participants.
Participants aged between 18-65.
The study will recruit both individuals with a clinical diagnosis of stroke and healthy participants
Participants with a score of 26 and above on MOCA
|
|
| ExclusionCriteria |
| Details |
Cognitive impairment
Fixed joint contractures or deformities
Visual or auditory impairment
Other medical conditions, such as cardiovascular or respiratory illness.
Recent orthopedic injury or surgery to the limbs or spine within the past 6 months
Patients with Apraxia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To design and develop VOMAS, a sensor-integrated device
To evaluate the sensitivity, specificity, and accuracy of VOMAS in identifying VMC impairment with the Brunnstrom Recovery Stages
|
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the sensitivity, specificity, & accuracy of VOMAS in identifying VMC impairment with the Brunnstrom Recovery Stages
|
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="148"
Sample Size from India="148"
Final Enrollment numbers achieved (Total)= "148"
Final Enrollment numbers achieved (India)="148" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2026 |
| Date of Study Completion (India) |
15/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study focuses on the design, development, and evaluation of the Voluntary Motor Assessment System (VOMAS), a wearable sensor-based device created to objectively assess voluntary motor control in individuals with stroke. The device uses sensors placed on the shoulder, elbow, and wrist to measure joint movements during structured upper-limb tasks. It records quantitative parameters such as range of motion and movement control, and applies a standardized 7-point grading scale developed from existing motor control assessment frameworks. The study uses a cross-sectional diagnostic accuracy design, comparing VOMAS results with the Brunnstrom Stages of Motor Recovery. The goal is to provide a reliable, objective, and clinically useful tool to support occupational therapists in assessment and rehabilitation planning. |