| CTRI Number |
CTRI/2026/01/101428 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| 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
|
Using virtual reality to improve hand and arm function and quality of life in people with neck level spinal cord injury |
|
Scientific Title of Study
|
Feasibility of Non- Immersive Virtual Reality for Distal Upper Extremity Motor Recovery and Quality of Life in Tetraplegia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Stuti Sehgal |
| Designation |
Associate professor |
| Affiliation |
ISIC- Institute of Rehabilitation Sciences |
| Address |
ISIC- Institute of Rehabilitation Sciences, Opp Sector C Main Vasant Kunj Road, New Delhi
South West
DELHI
110070
India |
| Phone |
09891847488 |
| Fax |
|
| Email |
sehgalstutiss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ridhi Gulati |
| Designation |
Post graduate student ( Master of Physiotherapy) |
| Affiliation |
ISIC- Institute of Rehabilitation Sciences |
| Address |
ISIC- Institute of Rehabilitation Sciences, Opp Sector C Main Vasant Kunj Road, New Delhi
South West
DELHI
110070
India |
| Phone |
09868308373 |
| Fax |
|
| Email |
ridhigulati1203@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit Mehndiratta |
| Designation |
Associate professor |
| Affiliation |
Indian Institute of Technology Delhi |
| Address |
Centre for Biomedical Engineering, Block III, Room No: 298, Indian Institute of Technology Delhi (IIT-D), Hauz Khas New Delhi
South West
DELHI
110016
India |
| Phone |
09891418288 |
| Fax |
|
| Email |
amehndiratta@cbme.iitd.ac.in |
|
|
Source of Monetary or Material Support
|
| Indian spinal injuries centre, Opp Sec C Main Vasant Kunj Road, New Delhi, Delhi 110070, India |
|
|
Primary Sponsor
|
| Name |
Indian Spinal Injuries Center |
| Address |
Sector C Main Vasant Kunj Road, New Delhi, Delhi-110070 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Stuti Sehgal |
Indian spinal injuries centre |
PMR department, ISIC, Sector C Main Vasant Kunj Road, New Delhi, Delhi-110070, India
South West
DELHI |
09891847488
sehgalstutiss@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indian Spinal Injuries Cente Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Conventional physiotherapy
|
Frequency- 45 min a day, 5 times a week for 4 weeks.
Strength training of the target upper limb (active or active assisted movements) and,
Functional tasks such as reaching, moving checkers, grasping and releasing objects, and manipulating and rotating objects
|
| Intervention |
Non-Immersive Virtual reality + Conventional physiotherapy
|
Frequency- 20 sessions (one session/day for 5 days/week for 4 weeks) of 45-min of intervention time during each session.
The joystick facilitates movement of the wrist with a flexion/extension and radial/ulnar deviation motion with ±15 degrees of yaw and pitch angle respectively from its mean position.
Front-button of the joystick (button 1) was used for flexion/extension training of the index finger, while buttons on top of joystick (buttons 2–5) were used for training of thumb with abduction/adduction motion.
The goal of the subject was to reach a pre-defined target-position within a specified time-bound, while travelling through a track with various obstacles.
Two different environments in a graded manner of difficulties i.e., Individual Environment and
Combined Environment
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Level of injury: complete or incomplete motor paralysis due to SCI at the neurological level of C5–C8
Duration of injury equals to or more than 3 months
Ability to hold a 2.54-cm block of Box and Block apparatus with the thumb |
|
| ExclusionCriteria |
| Details |
Patients had pre-diagnosed any other type of neurological injury affecting the target upper limb
Uncorrected visual and hearing impairment that would interfere in study
Patients with pain in the affected upper limb restricting upper limb movement
Individuals with MOCA score less than 26
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Engagement- Attendance
Adherence- Number of sessions completed
Satisfaction- User Satisfaction Evaluation Questionnaire
Exertion- Borg CR10 scale
|
4 weeks- post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
27/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/01/2026 |
| 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 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
|
This feasibility study investigates the use of non immersive virtual reality for improving distal upper extremity motor recovery and quality of life in individuals with tetraplegia due to cervical spinal cord injury. Upper limb dysfunction significantly affects independence, and conventional therapy often faces challenges related to engagement and adherence. VR-based rehabilitation offers task-oriented, repetitive training that may enhance neuroplasticity and patient motivation. The study aims to evaluate the usability, safety, satisfaction, engagement and adherence of non immersive VR compared to conventional therapy. A total of 12 participants will be randomly allocated into two groups VR plus conventional therapy and conventional therapy alone, over a 4 week intervention period. Outcomes will assess motor recovery, quality of life, and feasibility measures using standardized tools such as GRASSP, Box and Block Test, SCI-QOL, and SCIM III. Descriptive and exploratory statistical analyses will be performed to compare both groups.
|