| CTRI Number |
CTRI/2025/07/090708 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Testing a remote-controlled balance board to improve balance in stroke patients |
|
Scientific Title of Study
|
Development and testing of a remote-controlled balance board for independent use of stroke subjects: An exploratory study |
| 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 Urvi Kanjariya |
| Designation |
Pg scholar |
| Affiliation |
Marwadi University |
| Address |
MB557, Marwadi University Physiotherapy Department, Marwadi University, Rajkot-Morbi Road, Gauridad, Rajkot 360003, Gujarat, India
Rajkot
GUJARAT
360003
India |
| Phone |
09727051963 |
| Fax |
|
| Email |
urvi.kanjariya123795@marwadiuniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.ASHISH KAKKAD |
| Designation |
Principal and professor |
| Affiliation |
Marwadi University |
| Address |
Marwadi University, Rajkot-Morbi Road, Gauridad, Rajkot 360003, Gujarat, India
Rajkot
GUJARAT
360003
India |
| Phone |
9824415797 |
| Fax |
|
| Email |
ashish.kakkad@marwadieducation.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Urvi Kanjariya |
| Designation |
Pg scholar |
| Affiliation |
Marwadi University |
| Address |
MB557, Marwadi Physiotherapy OPD, Marwadi University, Rajkot-Morbi Road, Gauridad, Rajkot 360003, Gujarat, India
Rajkot
GUJARAT
360003
India |
| Phone |
09727051963 |
| Fax |
|
| Email |
urvi.kanjariya123795@marwadiuniversity.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Urvi Kanjariya |
| Address |
Marwadi University, Rajkot-Morbi Highway, Gauridad, Rajkot, Gujarat-360003 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Urvi Kanjariya |
Marwadi Physiotherapy opd |
Marwadi University, Rajkot-Morbi Road, Gauridad, Rajkot 360003, Gujarat, India
Rajkot
GUJARAT |
09727051963
urvi.kanjariya123795@marwadiuniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Marwadi University Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONENTIONAL PHYSIOTHERAPY TREATMENT |
STROKE PATIENTS WILL CONTINUE WITH THEIR ROUTINE PHYSIOTHERAPY WITHOUT THE USE OF THE REMOTE-CONTROLLED BALANCE BOARD FOR 4 WEEKS |
| Intervention |
REMOTE-CONTROLLED BALANCE BOARD |
STROKE SUBJECTS WILL RECEIVE TRAINING USING THE REMOTE-CONTROLLED BALANCE BOARD IN ADDITION TO THEIR USUAL CONVENTIONAL TREATMENT FOR 4 WEEKS |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
MMSE score more than equal to 24
medically stable
post stroke patients |
|
| ExclusionCriteria |
| Details |
Subjects not willing to participate
Severe vestibular disorders
pregnancy
severe musculoskeletal conditions
severe cognitive impairments
visual impairments
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
berg balance scale
system usability scale |
before and after 4 weeks of intervention |
|
|
Secondary Outcome
|
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/07/2025 |
| 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="1"
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 - NO
|
|
Brief Summary
|
Need for Study: There is a growing demand for rehabilitation tools that allow patients with limited mobility to engage in balance training more safely and independently. By integrating a remote-control mechanism, the proposed device aims to empower users to perform balance activities with less dependence on a therapist. This could enhance patient safety, confidence, and engagement. Moreover, the study intends to assess how the innovative design impacts rehabilitation outcomes, especially for users with high body weight or varying balance abilities. Aim: To develop and test a remote-controlled balance board for independent use by stroke patients. Objectives: 1. To develop a functional prototype of a balance board that can be operated via remote control. 2. To assess ease of use, patient experience, and safety in normal individuals using the remote-controlled balance board. 3. To determine whether the device enhances balance training outcomes and reduces dependence on therapist support in stroke patients. Methodology: The study will be conducted over 4 weeks and divided into three phases:
Phase I—Development Phase: Design and development of the remote-controlled balance board prototype, focusing on portability, safety, weight capacity, and adjustable tilting features.
Phase II—Preliminary Testing Phase: Testing the device on healthy adult individuals to evaluate its safety, functionality, and ease of use. Feedback from this phase will be used to make necessary modifications.
Phase III—Stroke Subject Phase: Implementation of the device with stroke patients, comparing the outcomes of those using the balance board in addition to conventional physiotherapy versus those receiving only conventional treatment.
|