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

NCT07086365 | Completed

• 1 other identifier: 1134 UIEC
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke Acute

Keywords

stroke; rehabilitation; neurorehabilitation

Outcome Measures

Primary Outcomes (2)

• System Usability Scale [SUS]

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

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

• User Satisfaction Evaluation Questionnaire [USEQ]

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

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

Secondary Outcomes (4)

• Fugl-Meyer Assessment for Upper Extremity

  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.

• Motor Activity Log

  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.

• Box and block test

  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.

• Medical research council

  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.

Study Arms (2)

10 session

OTHER

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

Device: Immersive virtual reality

20 sessions

OTHER

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

Device: Immersive virtual reality

Interventions

Immersive Virtual Reality DEVICE

Virtual reality with hand tracking and immersive environment

10 session; 20 sessions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Alemana de Santiago: lead

Study Sites (1)

Clinica Alemana

Santiago, Santiago Metropolitan, 8340518, Chile

Location

Related Publications (2)

• 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.

  PMID: 36772757 BACKGROUND

• Peralta-Wieland B, Vasquez-Torres R, Maldonado-Diaz M, Yoma M. Immersive Virtual Reality-Based Rehabilitation for Upper Limb Recovery in Acute and Subacute Stroke Patients: A Feasibility Study. Physiother Res Int. 2026 Jan;31(1):e70151. doi: 10.1002/pri.70151.

  PMID: 41416487 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ricardo Vasquez

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: July 25, 2025
• Study Start: March 29, 2023
• Primary Completion: December 30, 2024
• Study Completion: March 18, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)