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NCT Number: NCT07086365

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

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

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Key information

Conditions

Stroke Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Alemana

Santiago, Santiago Metropolitan, 8340518, Chile

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

immersive virtual reality

Device

Virtual reality with hand tracking and immersive environment

Primary outcomes

  1. System Usability Scale [SUS]

    Time frame: The treatment providers fill out the questionnaire at the end of treatment. It depends of the group patient: 10 or 20-session treatment.

    Questionnaire completed by the handlers who administer the immersive virtual reality system

  2. User Satisfaction Evaluation Questionnaire [USEQ]

    Time frame: Administered within the first 7 days of using the immersive virtual reality device

    Questionnaire of 5 questions with 5 options based on likert rate. Is filled for the patient recruited

Secondary outcomes

  1. Fugl-Meyer Assessment for Upper Extremity

    Time frame: It is administered in three stages: Baseline or day 1 (pre treatment). In the week number 4 (post treatment). Up to 8 weeks (follow-up). Through study completion, an average of 6 months.

    Clinical assessment scale for upper extremity function. It evaluates various functional areas of the upper extremity: wrist, hand, coordination, and speed. This provides a total of 66 motor function points.

  2. Motor Activity Log

    Time frame: It is administered in three stages: Baseline or day 1 (pre treatment). In the week number 4 (post treatment). Up to 8 weeks (follow-up). Through study completion, an average of 6 months.

    Questionnaire of 30 questions for quality of functional movement and 30 questions of quantity of functional movement of upper extremity. The maximal score is 150 for both quantity and quality.

  3. Box and block test

    Time frame: It is administered in three stages: Baseline or day 1 (pre treatment). In the week number 4 (post treatment). Up to 8 weeks (follow-up). Through study completion, an average of 6 months.

    Patient must to pick up little boxes and carry on in a standarized box. Patient must perform the test with both hands, with paresis and without paresis in 1 minute per each upper extremity.

  4. Medical research council

    Time frame: It is administered in three stages: Baseline or day 1 (pre treatment). In the week number 4 (post treatment). Up to 8 weeks (follow-up). Through study completion, an average of 6 months.

    Manual test muscle that use oxford graduation. M0 total weakness to M5 is normal strenght

Sponsors and collaborators

Lead sponsor

Clinica Alemana de Santiago

Other

Registry information

Acronym: IMVR Stroke

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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