Feasibility of Using Immersive Virtual Functional Rehabilitation for Recovery of Upper Extremity Function in Patients With Early-stage Stroke: a Pilot Study (IMVR Stroke)

Clinica Alemana de Santiago

Status: Completed

Conditions: Stroke Acute

Treatments: Device: Immersive Virtual Reality; Device: Immersive virtual reality

Study type: Interventional

Funder types: Other

Identifiers

NCT07086365

1134 UIEC

Details and patient eligibility

About

Feasibility of using immersive virtual functional rehabilitation for recovery of upper extremity function in patients with early-stage stroke: a pilot study

Full description

Background: Immersive virtual reality (IVR)-based rehabilitation provides high-intensity, engaging, task-oriented training and motor exploration for upper limb (UL) recovery post-stroke. However, its feasibility and dose-response effects remain unclear.

Objective: To evaluate the feasibility and dose-response effects of IVR-based rehabilitation for UL recovery in early stroke patients.

Methods: A pilot trial included 12 early-stage stroke patients randomized into two groups: Group A (10 IVR sessions + conventional rehabilitation [CR]) and Group B (20 IVR sessions + CR). Feasibility outcomes included adherence, usability (User Satisfaction Evaluation Questionnaire [USEQ], System Usability Scale [SUS]), system operability, and adverse effects. Motor outcomes, categorized by the International Classification of Functioning, Disability, and Health (ICF), assessed UL impairment (Fugl-Meyer Assessment, Medical Research Council scale), activity (Box and Block Test), and participation (Motor Activity Log 30). Blinded therapists conducted assessments at baseline, post-intervention, and 4-week follow-up. Dose-response was analyzed using Probability of Superiority (PS).

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age > 18 years old
• first episode of stroke (ischemic or hemorrhagic)
• time since stroke onset between 0 to 6 months
• upper limb motor impairment with the National Institutes of Health Stroke Scale arm motor sub-item score between 1 and 4
• medically stable parameters for rehabilitation initiation.

Exclusion criteria

• Delirium diagnosed using the Confusion Assessment Method
• Montreal Cognitive Assessment Scale <18
• Severe visual/perceptual deficits (spatial neglect affecting >70% of trials or visual acuity <20/200)
• previous participation in virtual reality-based rehabilitation
• inability to provide informed consent.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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11 participants in 2 patient groups

10 session

Other group

Description:

Participants receive 10 sessions of intervention with virtual inmersive reality. Virtual reality with hand tracking and immersive environment

Treatment:

Device: Immersive virtual reality

20 sessions

Other group

Description:

Participants receive 20 sessions of intervention with virtual inmersive reality. Virtual reality with hand tracking and immersive environment.

Treatment:

Device: Immersive virtual reality