| CTRI Number |
CTRI/2025/09/094934 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Testing Visual Feedback with Supported Treadmill Training to Improve Balance and Walking in People with Stroke |
|
Scientific Title of Study
|
Additive Effect of Visual Biofeedback with Body-Weight Support Treadmill Training on Balance and Gait Speed in Subacute Stroke An Experimental 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 |
Ayushi Mantri |
| Designation |
Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul institute of physiotherapy parul university neuro opd room no 201 post office limda taluka waghodia vadodara gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9552059894 |
| Fax |
|
| Email |
ayushimantri24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr jigisha vaniya |
| Designation |
Assistant professor |
| Affiliation |
parul Institute of Physiotherapy |
| Address |
Parul institute of physiotherapy parul university neuro opd room no 201 post office limda taluka waghodia vadodara gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
800070593 |
| Fax |
|
| Email |
jigishavaniya95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr jigisha vaniya |
| Designation |
Assistant professor |
| Affiliation |
parul Institute of Physiotherapy |
| Address |
Parul institute of physiotherapy parul university neuro opd room no 201 post office limda taluka waghodia vadodara gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
800070593 |
| Fax |
|
| Email |
jigishavaniya95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Sevashram Hospital Parul University PO Limda Tal Waghodia Dist Vadodara 391760 Gujarat State India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Ayushi Mantri |
Parul Sevashram Hospital |
Parul Sevashram Hospital 2nd floor neurophysiotherapy department room no 201 post office limda taluka waghodia vadodara gujarat
Vadodara
GUJARAT |
09552059894
ayushimantri24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional ethics committee for human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Auditory Biofeedback with Bodyweight Support Treadmill Training with Conventional Rehabilitation |
5 days per week for 3 weeks Harness with 30–40percent support start 0.5 mph 20 min progress to 2.5 mph 30 min by week 3 with auditory cues and therapist assistance as needed. |
| Intervention |
Visual Biofeedback with Bodyweight Support Treadmill Training with Conventional Rehabilitation |
Bodyweight support treadmill training uses a treadmill with body-weight support and visual feedback. Training starts at 30–40percent support 0.5 mph for 20 min and progresses to less support 2.5 mph and 30 min by week 3 for 5days per week |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient with a first-ever stroke of more than 3 months.
Both men and women who were older than 40 to 70 years.
Able to walk 3 m with or without ambulatory aids.
Patient who has a Mini-Mental State Examination score of more than 24.
|
|
| ExclusionCriteria |
| Details |
Presence of significant medical complications or unstable vital signs that precluded participation in the study (orthopedic condition such as severe arthritis) fracture of the lower limb replacement arthroplasty of the lower limb.
Patient with cardiac diseases.
Movement disorder.
Hemiplegia due to Traumatic Brain Injury.
Significant cognitive deficits.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg Balance Scale
|
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
10-Meter Walk Test
|
3 Weeks |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
20/10/2025 |
| 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="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 - NO
|
|
Brief Summary
|
Background
Stroke is a major cause of long-term disability frequently resulting in impaired balance, reduced gait speed, and functional dependence. Restoring independent walking is a key goal of rehabilitation in the subacute stage. Body-Weight Support Treadmill Training (BWSTT) is widely used as it provides task-specific, repetitive gait practice under safe conditions with partial unloading of body weight, thereby improving stepping ability and mobility. Despite these benefits, postural asymmetry and abnormal gait patterns often persist after BWSTT. Visual biofeedback, delivered through mirrors, can provide real-time information about posture and movement. This enhances self-awareness, facilitates motor learning, and promotes cortical reorganization, thereby helping patients achieve more symmetrical gait and better postural control. Purpose
The purpose of this study is to evaluate the additive effect of visual biofeedback combined with BWSTT on balance and gait speed in subacute stroke patients. By integrating real-time feedback with treadmill-based gait training, this trial aims to determine whether the combined intervention accelerates recovery, improves walking performance, and enhances functional independence compared to BWSTT with auditory feedback. |