Effects of Different Doses of Virtual Reality Therapy in Chronic Stroke Patients

June 16, 2026 updated by: Başak Can, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Comparison of the Effects of Different Doses of Virtual Reality Therapy on Motor Functions in Chronic Stroke Patients - A Randomized Controlled Single-Blind Study

This study aimed to compare the effects of different doses of Wii Fit-based virtual reality (VR) therapy added to conventional rehabilitation in patients with chronic stroke. Forty-three patients were randomly assigned to three groups: a control group receiving conventional rehabilitation only (5 days/week, 45 min/session for 4 weeks), a VR3 group receiving conventional rehabilitation plus VR training three days per week (20 min/session, 12 sessions total), and a VR5 group receiving conventional rehabilitation plus VR training five days per week (20 min/session, 20 sessions total). Balance (Berg Balance Scale), functional independence (Functional Independence Measure), stroke-specific quality of life (SS-QOL), static postural alignment (Becure Posture Mobile), and center of pressure measurements (Becure Balance System) were assessed before treatment (T0), after treatment (T1), and at one-month follow-up (T2). This prospective, single-blind, randomized controlled trial was conducted at Istanbul Physical Medicine Rehabilitation Training and Research Hospital.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Design

This was a prospective, single-blind (assessor-blinded), randomized controlled trial conducted at Istanbul Physical Medicine Rehabilitation Training and Research Hospital. Ethical approval was obtained from the Istanbul University-Cerrahpasa Clinical Research Ethics Committee (Protocol No: 2025/28). Written informed consent was obtained from all participants prior to enrollment.

Participants

Patients with chronic stroke (onset >6 months) aged 20-75 years were screened for eligibility. Inclusion criteria: diagnosed with ischemic or hemorrhagic stroke, Mini-Mental State Examination (MMSE) score ≥18. Patients were excluded if they had an MMSE score below 18, a diagnosis of epilepsy, a diagnosis of intellectual disability, or visual and/or hearing impairment at a level that would affect participation in treatment.

Randomization

Eligible patients were randomized into three groups using a sealed envelope method: Control group (n=14), VR3 group (n=15), and VR5 group (n=14).

Interventions

All three groups received conventional physiotherapy and rehabilitation (45 min/session, 5 days/week, 4 weeks), including neurodevelopmental treatment, strengthening, and balance exercises. In addition to conventional therapy, the VR3 group received Wii Fit-based VR balance training 3 days/week (20 min/session, 12 sessions total) and the VR5 group received VR balance training 5 days/week (20 min/session, 20 sessions total). VR training was delivered using a Nintendo Wii Balance Board modified with four 16-bit pressure sensors (Becure Balance System). During the first two weeks, games were applied at beginner difficulty level with two repetitions per game; the final two weeks used advanced difficulty with the same repetition scheme. A physiatrist supervised all sessions for safety. Following the completion of the 4-week treatment period, all patients continued to receive conventional rehabilitation only during the 4-week follow-up interval between T1 and T2 assessments; no VR training was provided during this period.

Outcome Measures

Primary outcome: Berg Balance Scale (BBS; 0-56 points).

Secondary outcomes: Functional Independence Measure (FIM; 18-126 points), Stroke-Specific Quality of Life Scale (SS-QOL; 12 domains, 49 items), Becure Balance System center of pressure (COP) measurements under eyes-open and eyes-closed conditions (X, Y, D parameters), and static postural alignment via Becure Posture Mobile application (anterior, posterior, and lateral planes).

Assessment Timepoints

T0: Baseline (before treatment); T1: Post-treatment (immediately after 4 weeks); T2: Follow-up (4 weeks after treatment completion). All assessments were performed by an evaluator blinded to group allocation.

Statistical Analysis

Sample size was calculated based on the BBS with a medium effect size (partial eta squared=0.06), α=0.05, and power=0.85, yielding a minimum of 13 patients per group (39 total); accounting for 15% dropout, 45 patients were enrolled. Normality was assessed using the Shapiro-Wilk test. Between-group comparisons used One-Way ANOVA or Kruskal-Wallis test. Within-group changes over time were analyzed using repeated measures ANOVA or Friedman's test with Bonferroni correction. Group × time interactions were examined using two-way mixed ANOVA; when ANOVA assumptions were violated, the nparLD package (F1-LD-F1 design) in R was used. Effect sizes were reported as partial eta squared (η²p): small=0.01, medium=0.06, large=0.14. Baseline differences were controlled using ANCOVA. Statistical significance was set at p<0.05. Analyses were performed using IBM SPSS Statistics 26.0 and R/RStudio.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • BAHCELIEVLER
      • Istanbul, BAHCELIEVLER, Turkey (Türkiye), 34188
        • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of ischemic or hemorrhagic stroke confirmed by CT or MRI
  • Chronic stroke (onset ≥ 6 months prior to enrollment)
  • Age between 20 and 75 years
  • Mini-Mental State Examination (MMSE) score ≥ 18 (or MMSE-E for illiterate patients)
  • Willingness to participate and provide written informed consent

Exclusion Criteria:

  • Mini-Mental State Examination (MMSE) score < 18
  • Diagnosis of epilepsy
  • Diagnosis of intellectual disability
  • Visual and/or hearing impairment at a level that would affect participation in treatment methods

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Group
Participants received conventional physiotherapy and rehabilitation only (45 min/session, 5 days/week, 4 weeks), including neurodevelopmental treatment, strengthening, and balance exercises. No virtual reality training was applied. (n=14)
Behavioral: Conventional Physiotherapy and Rehabilitation
Conventional physiotherapy program including neurodevelopmental treatment, strengthening, and balance exercises. Applied to all three groups for 45 min/session, 5 days/week, over 4 weeks. Supervised by a physiotherapist.
Experimental: VR3 Group
Participants received conventional physiotherapy (45 min/session, 5 days/week, 4 weeks) plus Wii Fit-based virtual reality balance training 3 days/week (20 min/session, 12 sessions total). (n=15)
Behavioral: Conventional Physiotherapy and Rehabilitation
Conventional physiotherapy program including neurodevelopmental treatment, strengthening, and balance exercises. Applied to all three groups for 45 min/session, 5 days/week, over 4 weeks. Supervised by a physiotherapist.
Behavioral: Wii Fit-Based Virtual Reality Balance Training
Nintendo Wii Balance Board-based virtual reality balance training delivered using the Becure Balance System (modified with four 16-bit pressure sensors). Sessions lasted 20 minutes. VR3 group received 3 sessions/week (12 total); VR5 group received 5 sessions/week (20 total) over 4 weeks. Games were applied at beginner difficulty for the first 2 weeks and advanced difficulty for the final 2 weeks, with 2 repetitions per game. All sessions were supervised by a physiotherapist.
Other Names:
  • Exergaming
Experimental: VR5 Group
Participants received conventional physiotherapy (45 min/session, 5 days/week, 4 weeks) plus Wii Fit-based virtual reality balance training 5 days/week (20 min/session, 20 sessions total). (n=14)
Behavioral: Conventional Physiotherapy and Rehabilitation
Conventional physiotherapy program including neurodevelopmental treatment, strengthening, and balance exercises. Applied to all three groups for 45 min/session, 5 days/week, over 4 weeks. Supervised by a physiotherapist.
Behavioral: Wii Fit-Based Virtual Reality Balance Training
Nintendo Wii Balance Board-based virtual reality balance training delivered using the Becure Balance System (modified with four 16-bit pressure sensors). Sessions lasted 20 minutes. VR3 group received 3 sessions/week (12 total); VR5 group received 5 sessions/week (20 total) over 4 weeks. Games were applied at beginner difficulty for the first 2 weeks and advanced difficulty for the final 2 weeks, with 2 repetitions per game. All sessions were supervised by a physiotherapist.
Other Names:
  • Exergaming

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Berg Balance Scale (BBS)
Time Frame: Baseline (T0), post-treatment at 4 weeks (T1), and one-month follow-up (T2)
A 14-item clinical assessment tool measuring static and dynamic balance. Each item is scored 0-4; total score ranges from 0 to 56, with higher scores indicating better balance performance. The minimal clinically important difference (MCID) is 6 points for stroke patients.
Baseline (T0), post-treatment at 4 weeks (T1), and one-month follow-up (T2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Independence Measure (FIM)
Time Frame: Baseline (T0), post-treatment at 4 weeks (T1), and one-month follow-up (T2)
An 18-item scale assessing functional independence in activities of daily living across motor and cognitive domains. Total score ranges from 18 (complete dependence) to 126 (complete independence). Higher scores indicate greater functional independence.
Baseline (T0), post-treatment at 4 weeks (T1), and one-month follow-up (T2)
Stroke-Specific Quality of Life Scale (SS-QOL)
Time Frame: Baseline (T0), post-treatment at 4 weeks (T1), and one-month follow-up (T2)
A 49-item, 12-domain self-report scale assessing stroke-specific health-related quality of life. Domains include energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision, and work. Higher scores indicate better quality of life.
Baseline (T0), post-treatment at 4 weeks (T1), and one-month follow-up (T2)
Static Balance Assessment - Center of Pressure (Becure Balance System)
Time Frame: Baseline (T0), post-treatment at 4 weeks (T1), and one-month follow-up (T2)
Static balance assessed using the Becure Balance System (Nintendo Wii Balance Board modified with four 16-bit pressure sensors). Center of pressure (COP) displacement measured in X (mediolateral) and Y (anteroposterior) axes and total displacement distance (D) under eyes-open and eyes-closed conditions. Assessed bilaterally in double-leg stance for 15 seconds.
Baseline (T0), post-treatment at 4 weeks (T1), and one-month follow-up (T2)
Static Postural Alignment (Becure Posture Mobile)
Time Frame: Baseline (T0), post-treatment at 4 weeks (T1), and one-month follow-up (T2)
Postural alignment assessed using the Becure Posture Mobile application in anterior, posterior, and lateral planes. Parameters include shoulder, knee, and pelvic alignment angles. Higher deviations from neutral alignment indicate greater postural impairment.
Baseline (T0), post-treatment at 4 weeks (T1), and one-month follow-up (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Fatma Nur Kesiktaş, MD, PhD, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025/28

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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