Virtual Reality-Based Rehabilitation After Stroke: A Randomized Controlled Trial

NCT07409116 | Completed

• 1 other identifier: B4062023000218
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the added value of integrating virtual reality therapy (VRT) based balance training into conventional therapy (CT) for improving balance and gait in subacute stroke patients, and to evaluate the usability and patient satisfaction associated with the VRT based intervention, stroke patients will be recruited in the Neurorehabilitation Department of Erasme University Hospital. Patients will be randomized to a group performing only CT (CT group) and a group in which 20% of the daily CT was replaced by VRT involving standing balance exercises performed with an immersive headset (VRT group). Functional ambulation classification (FAC), gait speed and step length on 10 meters walking test (10MWT), walking distance on 2 minutes walking test (2MWT) and Berg Balance Scale (BBS) will be assessed at baseline (T0) and post-intervention (T1). Sensory reweighting in the VRT group will also be evaluated through the Sensory Organization Test (SOT) at T0 and T1. Usability of the VR system and patient satisfaction associated with virtual reality will be assessed at T1 in the VRT group through a questionary.

Conditions

Stroke Patients

Keywords

stroke; rehabilitation; balance; gait; virtual reality

Outcome Measures

Primary Outcomes (1)

• Change in Balance Performance from Baseline to Post-Intervention

  To address this objective, the Berg Balance Scale (0-56 points; higher scores indicate better balance) will be used to assess changes in functional balance performance from baseline to post-intervention.

  From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (1)

• Change in Sensory Contributions to Postural Control measured by the Sensory Organization Test (SOT).

  From enrollment to the end of treatment at 2 weeks

Other Outcomes (4)

• Patient-Reported Satisfaction and Acceptability of Virtual Reality Training at Post-Intervention

  1 questionnaire at the end of treatment at 2 weeks

• Change in Functional Ambulation Classification (FAC) Score

  From enrollment to the end of treatment at 2 weeks

• Change in Walking Endurance Measured by the 2-Minute Walk Test (2MWT)

  From enrollment to the end of treatment at 2 weeks

Study Arms (2)

Conventional Therapy (CT)

ACTIVE COMPARATOR

conventional therapy will focus on motor rehabilitation, individualized according to their specific functional needs (exercises for individual deficits and mainly comprised sit-to-stand transfers, balance exercises, walking independence exercises, ergocycle endurance exercises, and dual-task exercises)

Other: Standard Conventional Rehabilitation

Virtual Reality Therapy-Based Rehabilitation (VRT)

EXPERIMENTAL

This group will benefit from integrating virtual reality therapy (VRT) based balance training into conventional therapy (CT). Conventional therapy will be partially replaced by VRT (20% of the total weekly rehabilitation time over a 2-week period corresponding in five 20-minute segments each week, resulting in a total of 10 VRT sessions) in such a way that the overall daily duration of motor rehabilitation will be equivalent between the VRT and CT groups.

Other: Virtual Reality Rehabilitation Program

Interventions

Standard Conventional Rehabilitation OTHER

Conventional Therapy will focus on motor rehabilitation, individualized according to their specific functional needs (exercises for individual deficits and mainly comprised sit-to-stand transfers, balance exercises, walking independence exercises, ergocycle endurance exercises, and dual-task exercises)

Conventional Therapy (CT)

Virtual Reality Rehabilitation Program OTHER

The virtual reality system will consist of a fixed computer running Virtualis software (Virtualis, France) an HMD (HTC Vive, HTC, Taiwan) with a resolution of 2,160 × 1,200 pixels (Full HD), a horizontal field of view of 110◦ and a frame rate of 90 Hz, two portable controllers (Vive Controller, HTC, Taiwan) and two static force platforms designed to measure center of pressure (CoP) data synchronized with the immersive virtual environments. Each session will last 20 minutes and will be performed under therapist supervision The VR training will consist of different types of exercises: 1/ weight transfer exercises (e.g. skiing) 2/ scrolling exercises (e.g. scrolling in a tunnel); 3/ dual-task exercises (balance + fun upper limb exercises) and 4/ stability limit exercises.

Virtual Reality Therapy-Based Rehabilitation (VRT)

Eligibility Criteria

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

You may qualify if:

• Hemorrhagic or ischemic stroke within the past 6 months,
• Minimum age of 18 years old,
• Ability to stand and walk with or without assistance
• Mini-Mental State Examination score of more than 15/30
• Ability to understand instructions,
• No visual deficits hindering VR training and vi) a health status allowing for rehabilitation

You may not qualify if:

• other orthopedic or neurological disease altering the function of the paretic lower limb, balance or gait.

Sponsors & Collaborators

• Erasme University Hospital: lead
• Fonds Erasme pour la Recherche Médicale: collaborator

Study Sites (1)

Erasme University Hospital (Hôpital Universitaire de Bruxelles - H.U.B.)

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Chloé Sauvage, PhD

  Université Libre de Bruxelles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be a pragmatic, randomized controlled trial conducted in routine clinical settings

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 13, 2026
• Study Start: January 8, 2024
• Primary Completion: March 30, 2025
• Study Completion: May 10, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)