Virtual reality task-focused training to improve upper limb function after stroke

Effectiveness of Real Home Settings Via Virtual Reality Task Oriented Training on Upper Llimb Function in Patients With Stroke: A Multicenter, Randomized Controlled Clinical Trial.

This trial will test whether wearing a head-mounted virtual reality program of task-focused exercises can help adults 1–6 months after stroke improve movement and daily use of their affected arm.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 86 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Jinan, Shangdong)
• Trial ID: NCT06704074 on ClinicalTrials.gov

What this trial studies

Participants with first-time ischemic or hemorrhagic stroke 1–6 months after onset and residual hemiplegia will receive task-oriented upper-limb training delivered through a head-mounted virtual reality (VR) device. The VR sessions present varied, familiar virtual scenes and tasks designed to encourage reaching, grasping, and coordinated arm movements that are difficult to replicate during routine inpatient therapy. Treatments are delivered in-person at the enrolling site with repeated training sessions and standardized clinical outcome measurements of upper-limb motor function and activities of daily living. Safety, feasibility, and changes in motor scores will be recorded to compare VR task-oriented training with usual rehabilitation approaches.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–80 with a first ischemic or hemorrhagic stroke 1–6 months earlier, hemiplegia with Brunnstrom stage II–V, modified Ashworth <4, able to sit for 30 minutes, with sufficient vision/hearing and cognitive capacity to follow VR instructions, and who can provide informed consent.

Not a fit: Patients with prior strokes, severe cognitive impairment (MOCA ≤17), major skull defects or repairs, severe spasticity or other significant neurological/psychiatric comorbidities, pronounced unilateral neglect, or those unable to travel to the site or tolerate VR are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could help patients regain better arm movement and function in daily activities through engaging, intensive practice.

How similar studies have performed: Previous randomized and controlled studies of VR combined with task-oriented rehabilitation have shown modest to moderate improvements in upper-limb function, though results vary and larger, well-controlled trials are still needed.

Eligibility criteria

Inclusion Criteria:

-1. Ischemic or hemorrhagic stroke was diagnosed based on the history, symptoms, and signs combined with CT or MRI imaging; 2. First stroke, onset time from 1 to 6 months, age ≥ 18 - 80 years ; 3. Hemiplegia, Brunnstrom stage ≥ Ⅱ - Ⅴ, modified Ashworth grade \< 4; 4. Able to maintain sitting balance (with no or only minimal assistance) for at least 30 minutes to facilitate assessment and training; 5. No significant unilateral neglect (confirmed by tests such as the Schenkenberg Line Bisection Test); visual or corrected vision and hearing must be sufficient to meet the requirements for VR training and to understand instructions.

6.Patients or their family members signed informed consent to participate in the experiment.

Exclusion Criteria:

* 1\. Previous history of stroke, traumatic or non-vascular encephalopathy; 2. MOCA ≤ 17, and no sensory aphasia. 3. Skull defect or allogeneic repair; 4. combined with other neurological and mental diseases; 5. Previous diseases that may cause upper limb motor/sensory dysfunction, such as neck tumor or radiotherapy and chemotherapy history, cervical spondylosis, cervical spine or upper limb fracture history, traumatic brachial plexus injury history, arthritis, diabetes mellitus, myasthenia gravis, multiple sclerosis, etc.

  6\. Accompanied by obvious vertigo or dizziness symptoms or related diseases (such as motion sickness, Meniere's syndrome, otolithiasis, etc.); 6. Accompanied by obvious pain; 7. Significant pain in the affected upper limb or shoulder at rest or during activity (VAS ≥ 4 ) 8. Evidence of ataxia and cerebellar or brainstem lesions according to the NIHSS; 9. Ongoing participation in other clinical investigators; 10. Unstable condition, refusal to sign the informed consent, and unwillingness to cooperate with the examination and treatment.

Where this trial is running

Jinan, Shangdong

• a Head-mounted-display VR device — Jinan, Shangdong, China (RECRUITING)

Study contacts

• Study coordinator: jing Jing

Conditions: Stroke, stroke, rehabilitation, Task-oriented training, virtual reality, upper limb dysfunction