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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-29

Study Completion Date

2025-03-18

Brief Summary

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

Detailed Description

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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).

Conditions

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Stroke Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Pilot study evaluating the feasibility of using an immersive virtual reality device in patients with stroke in the acute and sub-acute stages. Preliminary functional outcomes about upper extremity function are also assessed.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

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

Group Type OTHER

Immersive virtual reality

Intervention Type DEVICE

Virtual reality with hand tracking and immersive environment

Immersive Virtual Reality

Intervention Type DEVICE

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.

Group Type OTHER

Immersive virtual reality

Intervention Type DEVICE

Virtual reality with hand tracking and immersive environment

Immersive Virtual Reality

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

Other Intervention Names

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Extended reality. Digital therapeutics.

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinica Alemana de Santiago

OTHER

Sponsor Role lead

Responsible Party

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Margarita Venegas

Ricardo Vasquez

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinica Alemana

Santiago, Santiago Metropolitan, Chile

Site Status

Countries

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Chile

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.

Reference Type BACKGROUND
PMID: 36772757 (View on PubMed)

Other Identifiers

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1134 UIEC

Identifier Type: -

Identifier Source: org_study_id

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