Feasibility of Using Immersive Virtual Functional Rehabilitation for Recovery of Upper Extremity Function in Patients With Early-stage Stroke: a Pilot Study
NCT ID: NCT07086365
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2023-03-29
2025-03-18
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
SINGLE
Study Groups
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10 session
Participants receive 10 sessions of intervention with virtual inmersive reality.
Virtual reality with hand tracking and immersive environment
Immersive virtual reality
Virtual reality with hand tracking and immersive environment
Immersive Virtual Reality
Immersive virtual reality is a digital therapeutic approach to enhance neuroplasticity using virtual environment and hand tracking for functional motion in upper extremity
20 sessions
Participants receive 20 sessions of intervention with virtual inmersive reality. Virtual reality with hand tracking and immersive environment.
Immersive virtual reality
Virtual reality with hand tracking and immersive environment
Immersive Virtual Reality
Immersive virtual reality is a digital therapeutic approach to enhance neuroplasticity using virtual environment and hand tracking for functional motion in upper extremity
Interventions
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Immersive virtual reality
Virtual reality with hand tracking and immersive environment
Immersive Virtual Reality
Immersive virtual reality is a digital therapeutic approach to enhance neuroplasticity using virtual environment and hand tracking for functional motion in upper extremity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Clinica Alemana de Santiago
OTHER
Responsible Party
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Margarita Venegas
Ricardo Vasquez
Locations
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Clinica Alemana
Santiago, Santiago Metropolitan, Chile
Countries
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References
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Demeco A, Zola L, Frizziero A, Martini C, Palumbo A, Foresti R, Buccino G, Costantino C. Immersive Virtual Reality in Post-Stroke Rehabilitation: A Systematic Review. Sensors (Basel). 2023 Feb 3;23(3):1712. doi: 10.3390/s23031712.
Other Identifiers
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1134 UIEC
Identifier Type: -
Identifier Source: org_study_id
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