Multisensory immersive VR plus treadmill for post-stroke motor and cognitive recovery

A Single-blind Randomized Controlled Trial of Multisensory Stimulation Virtual Reality to Improve Motor and Cognitive Function in Stroke Patients

This study tests whether adding multisensory immersive virtual reality to treadmill training helps adults recovering from stroke improve walking, movement control, and thinking.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Chongqing Medical University (other)
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT06275516 on ClinicalTrials.gov

What this trial studies

This single-blind randomized controlled trial compared multisensory immersive VR combined with treadmill training versus treadmill training alone in adults after a first stroke. Participants received 20 minutes per day of training for 30 days, with baseline and endpoint assessments of motor, cognitive, emotional, and daily living function. Motor outcomes included Fugl-Meyer, muscle strength/tone, Berg balance, and three-dimensional gait analysis, while cognitive testing included MMSE, MoCA, and other standardized cognitive measures; brain function was measured with fNIRS and fMRI. The trial enrolled ambulatory patients with moderate lower-extremity impairment and preserved basic cognition, and outcomes focused on changes in motor and cognitive performance after the intervention period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–85 with a first stroke, Fugl-Meyer lower-extremity score under 34, able to walk with minor assistance, and with MMSE 20–30 who can follow instructions and provide consent.

Not a fit: Patients with severe visual or hearing impairments, unrepaired cranial bone flaps or metallic implants, other conditions affecting lower-limb function, major psychiatric or neurological comorbidities, acute cardiopulmonary dysfunction, or who cannot follow instructions are unlikely to benefit or were excluded.

Why it matters

Potential benefit: If successful, combining immersive multisensory VR with treadmill training could accelerate recovery of gait, motor control, and cognitive function after stroke.

How similar studies have performed: Previous VR-based rehabilitation studies in stroke have shown modest improvements in motor function and balance, but immersive multisensory VR combined with treadmill training is less extensively tested and remains preliminary.

Eligibility criteria

Inclusion Criteria:

1. The first onset of stroke is diagnosed and confirmed according to the requirements of stroke
2. The Fugl-Meyer Assessment of Lower Extremity (FMA-LE) is less than 34.
3. 18-85 years of age.
4. Able to walk with minor assistance
5. MMSE score of 20-30 and ability to understand and follow instructions during the trial
6. Able to sign an informed consent form.

Exclusion Criteria:

1. Severe visual or hearing impairments.
2. Pregnant or breastfeeding women.
3. Patients with unrepaired cranial bone flaps or metallic implants following brain surgery.
4. Presence of other conditions affecting lower limb motor function, such as osteoarthritis or recent lower limb fractures.
5. History of severe psychiatric disorders, other neurological diseases, acute cardiopulmonary dysfunction, multiple organ failure, brain tumours, or epilepsy.

Where this trial is running

Chongqing, Chongqing Municipality

• The First Affiliated Hospital of Chongqing Medical University, First Branch — Chongqing, Chongqing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Dingqun Bai

Conditions: Stroke