CTRI

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CTRI Number

CTRI/2025/09/095296 [Registered on: 23/09/2025] Trial Registered Prospectively

Last Modified On:

17/09/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Physiotherapy (Not Including YOGA)

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

A clinical trial studying effectiveness of applying low intensity current behind the ears with simple balance exercises of head and neck to improve sitting balance in spinal cord injury patients.

Scientific Title of Study

Combined effect of galvanic vestibular stimulation (GVS) with vestibular exercises on sitting balance and functional independence in individuals with spinal cord injury

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	SHALINI SRIVASTAVA
Designation	MPT-Neurology student
Affiliation	Indian Spinal Injuries Centre-Institue of Rehabilitation Sciences
Address	Physiotherapy Department ,Second floor,Indian Spinal injuries centre New Delhi-110070 India South DELHI 110070 India
Phone	7895761465
Fax
Email	shalinishine22@gmail.com

Details of Contact Person
Scientific Query

Name	Garima Wadhwa
Designation	Assistant Professor
Affiliation	Indian Spinal Injuries Centre-Institue of Rehabilitation Sciences
Address	Physiotherapy Department ,Second floor,Indian Spinal injuries centre, New Delhi-110070 India South DELHI 110070 India
Phone	9650086472
Fax
Email	garimawdhw@gmail.com

Details of Contact Person
Public Query

Name	Garima Wadhwa
Designation	Assistant Professor
Affiliation	Indian Spinal Injuries Centre-Institue of Rehabilitation Sciences
Address	Physiotherapy Department ,Second floor,Indian Spinal injuries centre New Delhi-110070 India South DELHI 110070 India
Phone	9650086472
Fax
Email	garimawdhw@gmail.com

Source of Monetary or Material Support

Indian Spinal Injuries Centre -Institute of rehabilitation Sciences, Vasant Kunj, New Delhi, 110070

Primary Sponsor

Name	Indian Spinal injuries centre
Address	Indian Spinal injuries center IAA colony vasant kunj New Delhi-110070 India
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Shalini Srivastava	Indian Spinal Injuries Centre	Physiotherapy department,second floor,Indian Spinal Injuries Centre IAA Colony Vasant Kunj New Delhi 110070 South DELHI	7895761465 shalinishine22@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethical Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: G988\|\|Other disorders of nervous system,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Galvanic Vestibular Stimulation and Vestibular exercises	Sham group will receive Placebo stimulation for 20 minutes followed by vestibular exercises for 30 minutes. Total duration-5 times a week for 4 weeks
Intervention	Galvanic Vestibular Stimulation and vestibular exercises.	Active GVS group will recieve galvanic vestibular stimulation for 20 minutes followed by vestibular exercises for 30 minutes. Total duration-5 times a week for 4 weeks

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Traumatic SCI ASIA- A and B Neurological level-T6-T12 Ability to sit independently for more than 30seconds MMSE score more than 24

ExclusionCriteria

Details

Individuals with metal implants in their body, such as cerebral artery clips, cochlear implants, or pacemakers.
Psychiatric and any other neurological disorders.
Head injuries causing cognitive impairment.
Subjects with uncorrected hearing or visual impairment.
Any other complication-pressure sores, heterotopic ossification, contracture of lower limb.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
Sitting Balance with modified function reach test ,Function in sitting test and prokin-252	4 weeks

Secondary Outcome

Outcome	TimePoints
Functional independence with Spinal Cord independence measure.	4 weeks

Target Sample Size

Total Sample Size="28"
Sample Size from India="28"
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/ Phase 3

Date of First Enrollment (India)

28/09/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

28/09/2025

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="7"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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 / Introduction / Review of Literature

· Background : Spinal cord injury (SCI) is a lesion to the spinal cord resulting from a traumatic injury, causing neurological changes and compromising spinal cord activity to varying degrees. The global incidence of SCI is estimated to range between eight and 246 cases per million persons.

· Introduction : Most of the functional activities, such as eating, dressing, and transfers, are performed in a sitting position by people who have paraplegia. Hence sitting balance training is the main focus in this area.

· Review of Literature : Earlier research conducted by Anna et al.(2022)reported that Galvanic vestibular stimulation was an effective technique to improve balance in neurological conditions like stroke, while the study carried out by Zhe cui (2024) concluded that gaze stabilization exercises improve sitting balance in stroke. These studies focused on one training type in isolation only.

· Lacunae in Literature : A critical analysis of both these researches revealed a significant lacunae in the existing literature, wherein individual benefits of both the training protocols are well-documented, but there is a scarcity of research that conducts combined effectiveness of both techniques. The present study is designed to fill this gap, as it aims to combine the effects of galvanic vestibular stimulation(gvs) with vestibular exercises on sitting balance and functional independence in individuals with spinal cord injury

Objectives and Hypothesis

Primary objective : To find effect of active Galvanic vestibular stimulation combined with Vestibular rehabilitation training to improve sitting balance compared to sham stimulation combined with vestibular rehabilitation training.

Secondary objective :To find effect of active Galvanic vestibular stimulation combined with Vestibular rehabilitation training to improve functional independence compared to sham stimulation combined with vestibular rehabilitation training.

Null Hypothesis : Neither the galvanic vestibular stimulation combined with vestibular exercises nor vestibular exercises alone has any significant impact on improving sitting balance and functional independence in individulas with spinal cord injury.

Alternate Hypothesis : Both the galvanic vestibular stimulation combined with vestibular exercises and vestibular exercises alone has significant impact on improving sitting balance and functional independence in individulas with spinal cord injury.

Material and Methods

· Study Design : The study follows a randomized control study design with assessment at two time intervals. The baseline or pre -test is at week 0, a post -test after 4 weeks .

· Sample Size and method : The total Sample Size is 28 divided into two groups of 14 each i.e. one active gvs group and one sham stimulation group. The Sample Size Calculation was performed using G*Power software with a statistical power of 80%, and an alpha error of 5% and a 95% confidence interval.

· Enrolment Period : The Duration of the study is 4weeks.

· Total Study Duration : The entire study is expected to be completed within 5 to 6 months.

· Inclusion and Exclusion Criteria : This study shall include male and female, traumatic spinal cord injury individuals aged 18 to 60 years having ASIA-AIS A &B . Indiviuals with any musculoskeletal injury, head injury ,metals implants or having complications like pressure sores and contractures will be excluded.

· Study Procedure : The participants for the research shall be recruited from ISIC IRS vasant kunj, New Delhi via a purposive sampling method. Participants will be randomly assigned into 2 parallel groups using a computer-generated randomisation software. The active group will undergo a galvanic vestibular stimulation with vestibular exercises while the sham stimulation group will undergo a placebo stimulation with vestibular exercises program. Groups shall follow the training five times a week for 4 weeks along with their conventional rehabilitation..

· Assessment Tools : To evaluate outcomes, sitting balance will be tested using the FIST-SCI Modified functional reach test (MFRT),prokin-252 technobody,and functional independence will be tested by SCIM-III.

Statistical Analysis Plan :

The data will be analysed in SPSS software version 25 with descriptive statistics for both categorical (age, gender) and continuous data (Fist-SCI,MFRT,SCIM-III) via frequency, percentage and mean, median, standard deviation respectively. Normality will be checked using the Shapiro - Wilk test. Depending upon the distribution either parametric tests T-tests or non-parametric test Wilcoxon signed rank test will be used with a statistical significance level of 5%.