| CTRI Number |
CTRI/2026/04/107863 [Registered on: 08/04/2026] Trial Registered Prospectively |
| Last Modified On: |
08/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect Of Inner Ear Balance Training on Balance and Daily Life in Stroke Patients with Pusher Syndrome |
|
Scientific Title of Study
|
Effect Of Vestibular Rehabilitation on Balance and Quality of Life in Post Stroke Individuals with Pusher Syndrome A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
YASWANTHI R |
| Designation |
Postgraduate Student(MPT) |
| Affiliation |
SRM Institute of Science and Technology (SRMIST) Kattankulathur |
| Address |
Department Of Physiotherapy
SRM Institute of Science and Technology
SRMIST
SRM Nagar Kattankulathur
Chengalpattu District
Tamil Nadu
603203
India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7092423857 |
| Fax |
|
| Email |
yr6683@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
SURESH J |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of Science and Technology (SRMIST) Kattankulathur |
| Address |
Room No 14 Staff Room
Department Of Physiotherapy
SRM Institute of Science and Technology
SRMIST
SRM Nagar Kattankulathur
Chengalpattu District
Tamil Nadu
603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9698642928 |
| Fax |
|
| Email |
sureshj@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
SURESH J |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of Science and Technology (SRMIST) Kattankulathur |
| Address |
Room No 14 Staff Room
Department Of Physiotherapy
SRM Institute of Science and Technology
SRMIST
SRM Nagar Kattankulathur
Chengalpattu District
Tamil Nadu
603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9698642928 |
| Fax |
|
| Email |
sureshj@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| Self-funded
SRM Medical College Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
Yaswanthi R |
| Address |
SRM College of Physiotherapy
SRM Institute of Science and Technology
SRM Nagar Kattankulathur
Chengalpattu District
Tamil Nadu 603203
India |
| 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 |
| Yaswanthi R |
SRM Medical College Hospital and Research Centre |
SRM Nagar Potheri
Chengalpattu 603203
Kancheepuram
TAMIL NADU |
7092423857
yr6683@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Participants will receive conventional physiotherapy including range of motion exercises strengthening exercises functional training and gait training for 3–4 sessions per week for 6 weeks |
| Intervention |
Vestibular Rehabilitation |
Participants will receive conventional physiotherapy along with vestibular rehabilitation including gaze stabilization exercises balance training weight shifting exercises and galvanic vestibular stimulation administered 3–4 sessions per week for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 years and above with confirmed ischemic stroke having pusher syndrome with modified scale for contraversive pushing greater than or equal to 1 in acute to subacute stage less than or equal to 6 months post stroke and able to understand and respond to stroke specific quality of life questionnaire |
|
| ExclusionCriteria |
| Details |
Severe cognitive impairment with MMSE less than 18 severe postural or functional limitation unstable medical conditions such as uncontrolled hypertension renal or cardiac conditions progressive neuromuscular disorders orthopaedic or musculoskeletal limitations preventing safe participation other vestibular disorders including vertigo or menieres disease severe visual or sensory deficits and participation in other rehabilitation programs during the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Balance measured using Berg Balance Scale |
Baseline and at 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life measured using Stroke Specific Quality of Life Scale |
Baseline and at 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
21/04/2026 |
| 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
|
Stroke is a leading cause of disability worldwide and is often associated with impaired balance and reduced quality of life. Pusher syndrome is a condition seen in some post stroke individuals, characterized by altered perception of verticality and postural imbalance, which delays rehabilitation and increases risk of falls. Conventional physiotherapy focuses on improving motor function but may not adequately address vestibular and sensory integration deficits. Vestibular rehabilitation aims to improve balance and spatial orientation through gaze stabilization, balance training, and sensory integration techniques. This study aims to evaluate the effect of vestibular rehabilitation on balance and quality of life in post stroke individuals with pusher syndrome. A total of 42 participants will be randomly allocated into two groups. The control group will receive conventional physiotherapy, while the experimental group will receive conventional physiotherapy along with vestibular rehabilitation. The intervention will be given for 6 weeks. Outcome measures include Berg Balance Scale and Stroke Specific Quality of Life Scale, assessed at baseline and after 6 weeks. The study is expected to provide evidence on the effectiveness of vestibular rehabilitation in improving functional outcomes and quality of life in this population. |