Effect of Immersive Virtual Reality-Based Music Therapy on Cognitive and Motor Skills in Subacute Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from Baseline in Global Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA) at 6 Weeks
研究概览
简要总结
This clinical trial aims to investigate the effects of immersive virtual reality-based music therapy on cognitive and motor functions in individuals aged 50 to 75 years with subacute stroke (between 2 weeks and 6 months post-stroke). Participants will be randomly assigned to either a control group receiving conventional physiotherapy or an experimental group receiving conventional physiotherapy plus virtual reality-based music therapy.
The study will assess cognitive performance, upper extremity motor skills, stroke impact, balance, and spatial neglect before and after a 6-week intervention. All participants will be treated at Istanbul Aydın University VM Medical Park Hospital. The study has been approved by the ethics committee, and written informed consent will be obtained from all participants.
详细描述
This is a single-center, single bilind, randomized, controlled, prospective clinical trial designed to evaluate the effects of immersive virtual reality (VR)-based music therapy on cognitive functions, upper extremity motor skills, stroke impact, balance, and spatial neglect in patients with subacute stroke. The study targets individuals aged between 50 and 75 years who have experienced a stroke within the previous 2 weeks to 6 months. All participants will be recruited from Istanbul Aydın University VM Medical Park Hospital.
Participants will be stratified based on the side of hemispheric damage (right or left) and randomized into two equal groups (n=15 per group). The control group will receive conventional physiotherapy and rehabilitation 5 days per week for 6 weeks. The experimental group will receive the same conventional physiotherapy program along with additional immersive VR-based music therapy sessions twice a week. These VR sessions involve rhythm-based and music-supported tasks delivered through Oculus Quest 2 applications, including Ocean Rift and PianoVision.
Assessments will be performed at baseline and after the 6-week intervention period. Cognitive function will be assessed using standardized neuropsychological tools, and motor function will be evaluated through established stroke motor recovery scales. The Virtual Reality Sickness Questionnaire (VRSQ) will be administered after the first VR session to monitor adverse effects such as dizziness or nausea.
This trial adopts a stratified randomization method to enhance internal validity by balancing brain hemisphere involvement across groups. A power analysis conducted using G*Power (version 3.1) determined a sample size of 30 participants based on an effect size reported by Fan et al. (2024), with 95% power and α=0.05. The study protocol has been approved by the Non-Interventional Research Ethics Committee of Üsküdar University (Approval No: 61351342/020-1000, Date: March 27, 2025). Written informed consent will be obtained from all participants before enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors are blinded to group allocation. Participants and care providers are not blinded due to the nature of the interventions.
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation
- •Age between 50 and 75 years
- •Stroke onset more than 2 weeks and less than 6 months prior
- •Diagnosis of unilateral hemiplegic stroke
- •Preserved understanding, hearing, and speech abilities sufficient to engage with virtual reality games
排除标准
- •Medically unstable condition
- •Wheelchair use or inability to sit in a chair
- •Cognitive impairment preventing comprehension of study procedures
- •Hearing loss
- •Severe visual impairment
- •Refusal to participate in the study
- •Migraine with aura
- •History of motion sickness
结局指标
主要结局
Change from Baseline in Global Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA) at 6 Weeks
时间窗: Baseline and 6 weeks after the start of intervention
Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA), a standardized screening tool for global cognitive functioning. The assessment was conducted face-to-face by a trained evaluator. The MoCA consists of tasks evaluating memory, attention, executive functions, language, visuospatial skills, abstraction, calculation, and orientation. Scores range from 0 to 30. Higher scores indicate better cognitive performance. A score of 26 or higher is generally considered normal.
Change from Baseline in Visual Memory as Assessed by the Benton Visual Retention Test - Form F at 6 Weeks
时间窗: Baseline and 6 weeks after the intervention
Visual memory was evaluated using the Benton Visual Retention Test (BVRT), Form F, a standardized neuropsychological test that assesses short-term visual memory, visual perception, and visuoconstructive skills. In this version, participants were shown 15 geometric designs, each for 10 seconds, and were instructed to reproduce each design from memory immediately after viewing. Each figure was scored based on established accuracy criteria. The outcome measure was the total number of correctly reproduced designs, with scores ranging from 0 to 15. Higher scores indicate better visual memory performance. Increased errors may reflect difficulties in memory, attention, or visual-spatial processing.
Change from Baseline in Working Memory Performance as Assessed by the Digit Span Test at 6 Weeks
时间窗: Baseline and 6 weeks after the intervention
Working memory was measured using the Digit Span subtest from the Wechsler Adult Intelligence Scale. The test consists of forward and backward repetition of digit sequences. Participants were asked to repeat sequences in the same order (forward) and reverse order (backward). Each correct sequence was scored, and the total score was recorded. Scores typically range from 0 to 30. Higher scores reflect greater working memory capacity.
Change from Baseline in Executive Function as Assessed by the Wisconsin Card Sorting Test (WCST) at 6 Weeks
时间窗: Baseline and 6 weeks after the intervention
Executive function was assessed using the Wisconsin Card Sorting Test (WCST), which evaluates cognitive flexibility and problem-solving. Participants were required to match cards based on undisclosed rules and adapt as the rules changed. The outcome measure is the number of correct categories completed. The maximum number of categories is 6. Higher scores reflect better executive functioning.
Change from Baseline in Upper Extremity Motor Function as Assessed by the Fugl-Meyer Assessment of Upper Extremity (FMA-UE) at 6 Weeks
时间窗: Baseline and 6 weeks after the start of intervention
Motor function of the upper limb will be assessed using the Fugl-Meyer Assessment of Upper Extremity (FMA-UE), a validated and widely used scale in stroke rehabilitation. The FMA-UE evaluates reflex activity, volitional movement within and out of synergy, grasp, coordination, and speed. Scores range from 0 to 66, with higher scores indicating better motor function.
次要结局
- Change from Baseline in Balance Performance as Assessed by the Berg Balance Scale (BBS) at 6 Weeks(Baseline and 6 weeks after the start of intervention)
- Change from Baseline in Motor Recovery Assessed by Brunnstrom Staging at 6 Weeks(Baseline and 6 weeks after the start of intervention)
- Change from Baseline in Spatial Neglect Severity as Assessed by the Star Cancellation Test at 6 Weeks(Baseline and 6 weeks (only for participants with spatial neglect at baseline))
研究者
Suzan Aydın
Principal Investigator, Physiotherapist, Lecturer and Ph.D. Candidate in Physical Therapy and Rehabilitation
Bahçeşehir University