| CTRI Number |
CTRI/2026/01/102077 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
24/01/2026 |
| 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
|
Effect of vestibular exercises versus task oriented training on balance in children with cerebral palsy |
|
Scientific Title of Study
|
Effect Of Vestibular Exercise Program And Task Oriented Training On Balance In Children With Spastic Diplegic Cerebral Palsy: A Comparative 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 Snehal Dinkar Gawade |
| Designation |
Post Graduate Resident |
| Affiliation |
Maharashtra Institute of Physiotherapy Latur |
| Address |
Department Of Neuro Physiotherapy, OPD no-16, MIMSR Medical College Campus, Ambajogai - Latur Rd, Vishwanathpuram, Latur, Maharashtra
Latur
MAHARASHTRA
413531
India |
| Phone |
7039225467 |
| Fax |
|
| Email |
snehalgawade.627@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parag Narayankar |
| Designation |
Associate Professor |
| Affiliation |
Maharashtra Institute of Physiotherapy Latur |
| Address |
Department of Neuro Physiotherapy, OPD no-16, MIMSR Medical College Campus, Ambajogai - Latur Rd, Vishwanathpuram, Latur, Maharashtra
Latur
MAHARASHTRA
413531
India |
| Phone |
8600006655 |
| Fax |
|
| Email |
paragnarayankar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parag Narayankar |
| Designation |
Associate Professor |
| Affiliation |
Maharashtra Institute of Physiotherapy Latur |
| Address |
Department of Neuro Physiotherapy, OPD no-16, MIMSR Medical College Campus, Ambajogai - Latur Rd, Vishwanathpuram, Latur, Maharashtra
Latur
MAHARASHTRA
413531
India |
| Phone |
8600006655 |
| Fax |
|
| Email |
paragnarayankar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra Institute of Physiotherapy, Neuro Physiotherapy department OPD no-16 MIMSR campus,Ambejogai Road, Latur 413 531,India |
|
|
Primary Sponsor
|
| Name |
Maharashtra University of Health Sciences,Nashik |
| Address |
3RH3 C34,Vani Dindori Rd,Mhasrul Gaon,Nashik,Maharashtra 422004 |
| Type of Sponsor |
Other [STRG 2024-2025] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Maharashtra Institute of Physiotherapy Latur |
Maharashtra Institute of Physiotherapy,MIMSR campus,Ambejogai Road, Latur 413531,India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Snehal Dinkar Gawade |
Maharashtra Institute of Physiotherapy Latur |
Department of Neuro Physiotherapy OPD-16,Maharashtra Institute of Physiotherapy,MIMSR Medical College Campus,Ambajogai - Latur Rd,Vishwanathpuram,Latur
Latur
MAHARASHTRA |
7039225467
snehalgawade.627@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G801||Spastic diplegic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1)Task Oriented Training
2)Conventional Treatmeant |
1)Task-Oriented Training:
Functional lower-limb strengthening and gait training using task-specific activities such as sit-to-stand, stepping, obstacle walking, speed changes, and carrying tasks to improve dynamic balance and mobility
2)Conventional Treatmeant :
Stretching exercises in the affected muscle group
Strengthening exercises in the affected muscle group
|
| Intervention |
1)Vestibular Exercise Program
2)Conventional Treatmeant |
1)Vestibular Exercise Program:
Structured program focusing on vestibular adaptation and postural control through static and dynamic balance exercises, head movements, and gait training with directional changes
2)Conventional Treatmeant :
Stretching exercises in the affected muscle group
Strengthening exercises in the affected muscle group
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed with Spastic diplegic cerebral palsy
2.Spastic diplegic cerebral palsy children with age group of 5-15 years.
3.Spastic diplegic cerebral palsy children of both genders.
4.Cerebral palsy children who can understand and follow the instructions.
5.Gross Motor Function Classification System (GMFCS) SCALE LEVEL I or II
6.Spasticity grade 1 or 1+ according to Modified Ashworth Scale.
|
|
| ExclusionCriteria |
| Details |
1.Auditory impairments.
2.Vision impairments.
3.Cognitive impairment.
4.Mental retardation.
5.Orthopedic surgery up to 6 months/ Botulinum toxin injection.
6.Structural or fixed soft tissue deformities of lower extremities
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PBS-Pediatric Balance Scale |
Pre and Post Assessment on 0 week and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
06/02/2026 |
| 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="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
|
Participants will be screened based on predefined inclusion and exclusion criteria. The purpose and procedures of the study will be explained to the parents of the participants in the language best understood by them, and written informed consent will be obtained.
A total of 44 participants will be selected using a simple random sampling method and randomly allocated into two groups using the chit method. Pre- and post-intervention assessment of balance will be conducted using the Pediatric Balance Scale (PBS).
Group A (n = 22): Participants will receive a structured Vestibular Exercise Program consisting of static and dynamic balance activities, head movements, sitting, standing, and ambulation exercises aimed at enhancing vestibular input and postural control.
Group B (n = 22): Participants will receive Task-Oriented Training involving functional activities such as sit-to-stand, reaching, stepping, walking, balance challenges, and lower-limb strengthening tasks to improve functional balance and mobility.
Both groups will receive their respective interventions for 45 minutes per session, 5 days per week for 4 weeks, along with conventional physiotherapy, including stretching and strengthening exercises for the affected muscle groups. |