A pilot randomized study comparing non-immersive virtual reality–based upper- and lower-limb rehabilitation plus conventional therapy versus conventional therapy alone in post-stroke patients
| ISRCTN | ISRCTN12954640 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12954640 |
| Sponsor | Indian Institute of Technology Madras |
| Funder | Indian Institute of Technology Madras |
- Submission date
- 26/01/2026
- Registration date
- 09/02/2026
- Last edited
- 13/02/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Stroke frequently leads to upper- and/or lower-limb impairment, causing weakness and loss of voluntary motor control on one side of the body, which can limit tasks such as reaching, grasping, self-care, walking, standing, and balance. Conventional occupational therapy is effective but can be constrained by limited opportunities for engaging, high-repetition, task-oriented practice. Non-immersive virtual reality rehabilitation, delivered through camera-based motion tracking, provides structured exercise modules for both upper-limb and lower-limb rehabilitation, with real-time visual feedback and gamified tasks that encourage repetition and active participation. The aim of this study is to determine whether adding non-immersive virtual reality–based training to conventional occupational therapy results in greater functional improvement compared with conventional occupational therapy alone.
Who can participate?
Post-stroke patients aged 18 to 80 years with unilateral upper-limb and/or lower-limb weakness
What does the study involve?
Participants are randomly assigned to one of two groups:
1. Conventional occupational therapy alone (control group)
2. Non-immersive virtual reality–based rehabilitation plus conventional occupational therapy (intervention group)
Both groups receive structured rehabilitation sessions for 4 weeks. The virtual reality system uses a camera-based motion tracking method and task-oriented exercise games designed for upper-limb rehabilitation. Upper-limb function is assessed before and after the intervention period using standard clinical assessments of motor function, joint motion, and manual dexterity.
What are the possible benefits and risks of participating?
Participants may benefit from structured upper-limb rehabilitation and may experience improvement in upper-limb movements and function. Risks are minimal and similar to standard therapy, such as muscle fatigue, mild pain, or temporary discomfort. Some participants may experience mild tiredness or frustration during exercise games. All sessions are supervised and rest breaks are provided.
Where is the study run from?
Indian Institute of Technology Madras (India)
When is the study starting and how long is it expected to run for?
September 2023 to July 2024
Who is funding the study?
Indian Institute of Technology Madras (India)
Who is the main contact?
Dr Sourav Rakshit, srakshit@iitm.ac.in
Contact information
Principal investigator
Department of Mechanical Engineering
IIT Madras
Chennai
600036
India
 ORCID ID |
0000-0002-2734-3180 |
|---|---|
| Phone | +91 (0)6379665494 |
| srakshit@iitm.ac.in |
Public, Scientific
Chalk Kantalia, P.O. Sewli Telini para, North 24 Parganas, West Bengal, Pin
Barrackpore
700121
India
| Phone | +91 (0)7980965924 |
|---|---|
| me21s078@smail.iitm.ac.in |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Active | |
| Assignment | Parallel | |
| Purpose | Treatment | |
| Scientific title | A pilot randomized controlled study on the effectiveness of non-immersive virtual reality–based rehabilitation plus conventional occupational therapy versus conventional occupational therapy alone in improving upper- and lower-limb recovery in post-stroke hemiparetic patients | |
| Study objectives | Primary objective: To evaluate the effectiveness of non-immersive virtual reality–based rehabilitation targeting the upper and/or lower limbs, combined with conventional occupational therapy, compared with conventional occupational therapy alone, in improving functional recovery in post-stroke hemiparetic patients. Secondary objectives: 1. To compare weekly changes between groups in upper-limb motor function, passive joint motion, and manual dexterity, as well as lower-limb gait, balance, and functional mobility, after the intervention period. 2. To assess the usability and participant acceptability of the non-immersive virtual reality rehabilitation program. | |
| Ethics approval(s) |
Approved 19/08/2023, Institutional Research Ethics Board, INK Kolkata (Main Hospital: 185/1 A.J.C. Bose Road, Rehabilitation, Research & Psychiatric Centre: 10 West Range, Kolkata, 700017, India; +91 (0)7044060941; ganguly73@gmail.com), ref: N/A | |
| Health condition(s) or problem(s) studied | Upper- and/or lower-limb motor impairment and functional limitation following stroke (post-stroke hemiparesis) | |
| Intervention | Participants are randomized into two parallel groups. The control cohort receives conventional occupational therapy only. The intervention cohort receives non-immersive virtual reality–based rehabilitation targeting the upper and/or lower limbs in addition to conventional occupational therapy. Outcome assessors are blinded to group allocation (single-blinded design), while participant and therapist blinding is not feasible due to the nature of the intervention. | |
| Intervention type | Device | |
| Phase | Not Applicable | |
| Drug / device / biological / vaccine name(s) | Non-immersive virtual reality based rehabilitation system (camera-based motion tracking exergame platform using a webcam and computer) | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) | ||
| Completion date | 30/07/2024 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 22 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Age 18–80 years 2. Unilateral upper-extremity hemiparesis/hemiplegia 3. Medically stable 4. Brunnstrom stage ranging from 2 to 4 5. Modified Ashworth Scale <2 6. Adequate visual acuity (with corrective lenses if needed) 7. No visual neglect, apraxia, or visuospatial perceptual disorders (screened via MMSE visuospatial item and therapist-administered clock-drawing test) |
| Key exclusion criteria | 1. History of other neurodegenerative diseases 2. Epilepsy 3. Cardiac pacemaker 4. Severe visual impairment 5. Known case of fracture on the affected side |
| Date of first enrolment | 01/09/2023 |
| Date of final enrolment | 30/09/2023 |
Locations
Countries of recruitment
- India
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
13/02/2026: Contact details updated.
09/02/2026: Study's existence confirmed by the Institutional Research Ethics Board, INK Kolkata.
