Stroke PatientsNCT07409116
Virtual Reality-Based Rehabilitation After Stroke: A Randomized Controlled Trial
A study testing Standard Conventional Rehabilitation and Virtual Reality Rehabilitation Program in people with Stroke Patients, run by Erasme University Hospital at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Patients
- What is being tested?
- Standard Conventional Rehabilitation and Virtual Reality Rehabilitation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Jan 2024to 10 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- other orthopedic or neurological disease altering the function of the paretic lower limb, balance or gait.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Erasme University Hospital (Hôpital Universitaire de Bruxelles - H.U.B.)
Brussels, 1070
About this study
Official title: Study of the Effects of a Virtual Reality Balance Training Programme on the Balance and Walking Ability of Stroke Patients
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.
Read the detailed description
Outcomes :
Analyse the effects of a virtual reality balance rehabilitation programme added to conventional therapy on the balance and walking ability of stroke patients.
Analyse feedback from patients who have experienced virtual reality in terms of the usability of the system and patient satisfaction associated with virtual reality.
Participants :
Stroke patients will be recruited in the Neurorehabilitation Department of Erasme University Hospital. Inclusion criteria will be
- Hemorrhagic or ischemic stroke within the past 6 months,
- Age of more than 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 Exclusion criteria will be another orthopedic or neurological disease altering the function of the paretic lower limb, balance or gait.
Study design This study will be a pragmatic, randomized controlled trial conducted in routine clinical settings. Participants will be enrolled during their inpatient stay in the neurorehabilitation unit. Following enrolment, they will be randomly allocated to either the CT group (conventional therapy alone) or VRT group (CT + VRT program) using a computer-generated randomization procedure.
- Control group : conventional therapy alone 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)
- VRT group : Conventional therapy + virtual reality therapy. 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.
Virtual reality therapy 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.
Assessment Patients will be evaluated at two time points: at baseline (T0) and post-intervention (T1, after the two weeks intervention) using validated outcome measures. Functional Ambulation Classification (FAC) will be used to quantify the level of human assistance required for ambulation. Walking capacity will be assessed through the Two-Minute Walk Test (2MWT). Walking speed and stride length will be measured using the 10-meter walk test (10MWT). Postural stability will be evaluated using the Berg Balance Scale (BBS). In addition, participants assigned to the VRT group will undergo a virtual reality-based Sensory Organization Test (VR-SOT) to objectively assess postural control at T0 and T1, and they will be asked to complete a structured satisfaction questionnaire on VR at T1.
Statistical analysis Normality will be verified using the Shapiro-Wilk. For the the primary outcome analyses, a two-way repeated-measures ANOVA will be conducted to examine the group (CT vs. VRT), time (T0-T1) and group x time interaction.
Within the VRT group, changes in VR-SOT scores between T0 and T1 will be analyzed using the Wilcoxon signed-rank test with Holm-adjusted p values. Spearman correlation coefficients will be calculated to assess the relationships between changes in SOT scores and changes in functional outcomes.
- Conditions
- Stroke Patients
- Being tested
- Standard Conventional Rehabilitation, Virtual Reality Rehabilitation Program
- Keywords
- stroke, rehabilitation, balance, gait, virtual reality
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Conventional RehabilitationOther
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)
Virtual Reality Rehabilitation ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Other: Virtual Reality Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
In the VRT group, the Sensory Organization Test will be used to characterize potential changes in sensory integration for balance (score from 0 to 100%, higher scores indicate better postural control), from baseline to post-intervention. This test
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start8 Jan 2024
- Primary completion30 Mar 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a pragmatic, randomized controlled trial conducted in routine clinical settings
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds Erasme pour la Recherche Médicale
- Responsible party
- Sponsor
- Investigators
- Chloé Sauvage, PhD, Principal investigator, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409116
- Sponsor's protocol ID
- B4062023000218
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of a Virtual Reality Balance Training Programme on the Balance and Walking Ability of Stroke Patients
- ClinicalTrials.gov ID
- NCT07409116
- Acronym / sponsor ID
- B4062023000218
- Conditions
- Stroke Patients
- Keywords
- stroke, rehabilitation, balance, gait, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Fonds Erasme pour la Recherche Médicale
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Outcomes :
Analyse the effects of a virtual reality balance rehabilitation programme added to conventional therapy on the balance and walking ability of stroke patients.
Analyse feedback from patients who have experienced virtual reality in terms of the usability of the system and patient satisfaction associated with virtual reality.
Participants :
Stroke patients will be recruited in the Neurorehabilitation Department of Erasme University Hospital. Inclusion criteria will be
- Hemorrhagic or ischemic stroke within the past 6 months,
- Age of more than 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 Exclusion criteria will be another orthopedic or neurological disease altering the function of the paretic lower limb, balance or gait.
Study design This study will be a pragmatic, randomized controlled trial conducted in routine clinical settings. Participants will be enrolled during their inpatient stay in the neurorehabilitation unit. Following enrolment, they will be randomly allocated to either the CT group (conventional therapy alone) or VRT group (CT + VRT program) using a computer-generated randomization procedure.
- Control group : conventional therapy alone 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)
- VRT group : Conventional therapy + virtual reality therapy. 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.
Virtual reality therapy 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.
Assessment Patients will be evaluated at two time points: at baseline (T0) and post-intervention (T1, after the two weeks intervention) using validated outcome measures. Functional Ambulation Classification (FAC) will be used to quantify the level of human assistance required for ambulation. Walking capacity will be assessed through the Two-Minute Walk Test (2MWT). Walking speed and stride length will be measured using the 10-meter walk test (10MWT). Postural stability will be evaluated using the Berg Balance Scale (BBS). In addition, participants assigned to the VRT group will undergo a virtual reality-based Sensory Organization Test (VR-SOT) to objectively assess postural control at T0 and T1, and they will be asked to complete a structured satisfaction questionnaire on VR at T1.
Statistical analysis Normality will be verified using the Shapiro-Wilk. For the the primary outcome analyses, a two-way repeated-measures ANOVA will be conducted to examine the group (CT vs. VRT), time (T0-T1) and group x time interaction.
Within the VRT group, changes in VR-SOT scores between T0 and T1 will be analyzed using the Wilcoxon signed-rank test with Holm-adjusted p values. Spearman correlation coefficients will be calculated to assess the relationships between changes in SOT scores and changes in functional outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will be a pragmatic, randomized controlled trial conducted in routine clinical settings
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy (CT) | Active comparator | Other: Standard Conventional Rehabilitationconventional 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) |
| Virtual Reality Therapy-Based Rehabilitation (VRT) | Experimental | Other: Virtual Reality Rehabilitation ProgramThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (1 listed)
- other orthopedic or neurological disease altering the function of the paretic lower limb, balance or gait.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Conventional RehabilitationConventional 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 | Conventional Therapy (CT) |
| Virtual Reality Rehabilitation ProgramThe 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. | Other | Virtual Reality Therapy-Based Rehabilitation (VRT) |
Primary outcome
Change in Balance Performance from Baseline to Post-Intervention
Time frame: From enrollment to the end of treatment at 2 weeks
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.
1 secondary outcome
Change in Sensory Contributions to Postural Control measured by the Sensory Organization Test (SOT).
Time frame: From enrollment to the end of treatment at 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chloé Sauvage, PhD principal investigator
Université Libre de Bruxelles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Conventional Rehabilitation and Virtual Reality Rehabilitation Program in people with Stroke Patients, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Balance Performance from Baseline to Post-Intervention (time frame: From enrollment to the end of treatment at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.