CTRI

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CTRI Number

CTRI/2024/04/065897 [Registered on: 18/04/2024] Trial Registered Prospectively

Last Modified On:

21/07/2025

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 Electrical Stimulation with Video Game based training for Sitting Balance in Individuals with Incomplete Spinal Cord Injury

Scientific Title of Study

Effectiveness of Sensory Electrical Stimulation Augmented Virtual Reality Training in Improving Sitting Balance and Quality of Life in Individuals with Incomplete 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	Nikhil Chowdhary
Designation	Postgraduate Student (Master of Physiotherapy)
Affiliation	Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences
Address	Room No.7, 2nd floor, Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences (Neurology), Sector C, Vasant Kunj South West DELHI 110070 India
Phone	7889706797
Fax
Email	29nikhilchowdhary@gmail.com

Details of Contact Person
Scientific Query

Name	Dr. Shefali Walia
Designation	Associate Professor
Affiliation	Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences
Address	Neurology Faculty Room, 2nd floor, Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences (Neurology), Sector C, Vasant Kunj, New Delhi - 110070 South West DELHI 110070 India
Phone	9891770151
Fax
Email	shef0604@gmail.com

Details of Contact Person
Public Query

Name	Nikhil Chowdhary
Designation	Postgraduate Student (Master of Physiotherapy)
Affiliation	Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences
Address	Room No.7, 2nd floor, Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences (Neurology), Sector C, Vasant Kunj South West DELHI 110070 India
Phone	7889706797
Fax
Email	29nikhilchowdhary@gmail.com

Source of Monetary or Material Support

Indian Spinal Injuries Centre Institute of Rehabilitation Sciences

Primary Sponsor

Name	Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences
Address	Sector C, Vasant Kunj, New Delhi - 110070
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
Nikhil Chowdhary	Indian Spinal Injuries Centre	Neurology lab, 2nd floor, Institute of rehabilitation sciences, Sector C, Vasant Kunj, New Delhi - 110070 South West DELHI	7889706797 29nikhilchowdhary@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, Indian Spinal Injuries Centre	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: S24\|\|Injury of nerves and spinal cord at thorax level,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Sensory Electrical Stimulation (SES) Augmented Virtual Reality (VR) Training	Individuals in the intervention group will receive sensory electrical stimulation in the form of Transcutaneous electrical nerve stimulation (TENS) while performing virtual reality training using Nintendo Wii. The electrodes will be placed on the subjects skin corresponding to the belly of Erector Spinae muscle (Thoracolumbar region). VR training will be given using Nintendo Wii Sports Resort programs. The following games will be used - Table Tennis, Golf, Bowling, Frisbee, Swordplay and Canoe. The duration and frequency of the intervention will be 30 minutes a session, 5 sessions a week, for 4 weeks.
Comparator Agent	Virtual Reality (VR) Training	Individuals in the control group will receive VR training using Nintendo Wii. Nintendo Wii Sports Resort programs will be used. The following games will be used - Table tennis, Golf, Bowling, Frisbee, Swordplay and Canoe. The duration and frequency of the intervention will be 30 minutes session, 5 sessions a week, for 4 weeks.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. Diagnosis of SCI 2. T6- T12 Level of injury 3. ASIA B,C and D 4. Ability to sit unsupported for 10 seconds 5. Minimum of 90 degree shoulder flexion

ExclusionCriteria

Details

1. Uncorrected hearing or visual impairment
2. Deformity of upper limb, any other psychiatric, neurological or musculoskeletal impairment
3. History of severe recent urinary tract infection or autonomic dysreflexia
4. Refusal or inability to provide informed consent and inability to follow commands
5. Subjects with any contraindications for electrical stimulation such as pressure sores (grade 2 or more) at the site of stimulation and cardiac pacekmaker.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
Sitting Balance (Forward reach distance) using Modified Functional Reach Test	0 weeks (Baseline, Pre-test) and 4 weeks (Post-test)

Secondary Outcome

Outcome	TimePoints
Multidirectional reach distance using Star Test (Using Tecnobody Prokin 252)	0 weeks (Baseline, Pre-test) and 4 weeks (Post-test)
Quality of Life Using International Spinal Cord Society (ISCoS) QoL Basic Data Set Version 1.0	0 weeks (Baseline, Pre-test) and 4 weeks (Post-test)

Target Sample Size

Total Sample Size="22"
Sample Size from India="22"
Final Enrollment numbers achieved (Total)= "22"
Final Enrollment numbers achieved (India)="22"

Phase of Trial
Modification(s)

N/A

Date of First Enrollment (India)

29/04/2024

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="8"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

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

Spinal cord injury (SCI) is a debilitating neurological condition characterized by sensory, motor, autonomic, or bowel dysfunction caused by a lesion to neuronal elements of the spinal cord that leads to functional dependence, asymmetric posture, abnormal balance and deficits in ability to transfer weight. As most of the functional activities performed by individuals with SCI are carried out in sitting position, sitting balance is considered as a prerequisite for effective performance of activities of daily living.

Virtual Reality (VR) and Sensory Electrical Stimulation (SES) are two promising interventions that have shown to improve balance and quality of life (QoL) in individuals with various neurological disorders, but their combined effectiveness has not been explored yet. Hence this research aims to find their effectiveness on sitting balance and quality of life in individuals with incomplete SCI.

Patients will be screened based on inclusion and exclusion criteria. They will be enrolled into 2 groups with the help of random allocation software. One group (Experimental group) will receive SES augmented VR training and conventional physiotherapy 5 times a week for 4 weeks. Whereas the second group (control group) will receive VR training along with conventional physiotherapy for the same duration.

The outcome measurements will be done by mFRT(modified functional reach test), Star test and International Spinal Cord Injury Quality of Life Basic Data Set (IScoS QoL BDS Version 1.0). Variations in the pre and post outcome measurements will help us find out the effectiveness of SES augmented VR on sitting balance and QoL in individuals with incomplete SCI.