Chronic Stroke, Stroke
Conditions
Keywords
Virtual Reality, Wii Fit, Balance, Postural Control, Functional Independence, Quality of Life, Dose-Response, Neurological Rehabilitation
Brief summary
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.
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.
Interventions
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.
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Scale (BBS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Independence Measure (FIM) | 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. |
| Stroke-Specific Quality of Life Scale (SS-QOL) | 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. |
| Static Balance Assessment - Center of Pressure (Becure Balance System) | 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. |
| Static Postural Alignment (Becure Posture Mobile) | 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. |
Countries
Turkey (Türkiye)
Contacts
Istanbul Physical Medicine Rehabilitation Training and Research Hospital