Augmented reality vs virtual reality treadmill training to improve walking after stroke
Effects of Augmented Reality and Virtual Reality-Assisted Gait Training on Balance and Walking in Individuals With Stroke
This trial will test whether augmented reality or virtual reality treadmill training, compared with a home exercise program, helps people who had a stroke improve their balance and walking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ankara Yildirim Beyazıt University Academic / other |
| Locations | 1 site (Ankara, Çankaya) |
| Trial ID | NCT07113093 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll 66 post-stroke participants and randomize them to three groups: C-Mill VR-assisted treadmill training plus conventional physiotherapy, C-Mill AR-assisted treadmill training plus conventional physiotherapy, or a control group receiving a home exercise program alongside conventional physiotherapy. Training sessions are 45 minutes per day, five days a week, for three weeks using the C-Mill VR+ system, which provides immersive visual-auditory feedback, force sensing, and safety harnessing. Outcomes include clinical, functional, cognitive, and spatiotemporal gait measures analyzed within the International Classification of Functioning, Disability and Health (ICF) framework to quantify changes in balance and walking. The trial directly compares AR and VR approaches to determine which modality, if any, yields greater gait and balance improvements after stroke.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) with post-stroke hemiplegia (ICD-10 G81) who can walk with assistance or independently (Functional Ambulation Classification ≥2) and can tolerate treadmill training and the C-Mill system.
Not a fit: Patients with severe cognitive impairment (MoCA <10), aphasia or major communication barriers, high lower-extremity spasticity (MAS 3–4), recent botulinum toxin injections, recurrent strokes, other significant neurological or orthopedic conditions, or inability to use visual/hearing devices are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could speed recovery of walking, improve balance, and lower fall risk for people after stroke.
How similar studies have performed: Previous studies using the C-Mill and other VR/AR rehabilitation tools have shown gait improvements and reduced fall risk in older adults and Parkinson's disease, but randomized, direct comparisons of AR versus VR in stroke are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ICD-10 diagnosis code of G.81 (Hemiplegia) * Age 18 years or older * Ability to walk with assistance or independently (Functional Ambulation Classification score of 2 or higher) Exclusion Criteria: * Incomplete completion of the assessment form * Refusal to participate in the study * Aphasia * Montreal Cognitive Assessment score below 10 * Presence of extra neurological or orthopedic problems unrelated to stroke * Recurrent stroke * MAS score of 3-4 (lower extremity) * Volunteer's desire to withdraw from the study * Inability to adapt to the technological devices used in the study (e.g., visual or hearing impairments) * Missing three consecutive treatment sessions * Botulinum toxin-A (BONT-A) injection to the lower extremity during the treatment process or within the last 6 months
Where this trial is running
Ankara, Çankaya
- Ankara Bilkent City Hospital — Ankara, Çankaya, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Murat Akıncı, Msc
- Email: muratakinci.fzt@gmail.com
- Phone: +905529356978
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.