Clinical trial NCT07010536: Effect of Virtual Reality-Based Music Therapy on Cognitive and Motor Skills in Subacute Stroke Patients
Official title: Effect of Immersive Virtual Reality-Based Music Therapy on Cognitive and Motor Skills in Subacute Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Subacute Stroke
Virtual Reality
Immersive Virtual Reality
Cognitive Dysfunction
Motor Impairment
Keywords: Stroke
Music Therapy
Virtual Reality
Cognition Disorders
Motor Skills Disorders
Postural Balance
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to two parallel groups: a control group receiving only conventional physiotherapy, and an experimental group receiving conventional physiotherapy combined with immersive virtual reality-based music therapy. Both groups will receive interventions for 6 weeks, and outcomes will be compared between groups.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Epilepsy
* Migraine with aura
* History of motion sickness

Primary outcomes:
measure: Change from Baseline in Global Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA) at 6 Weeks
timeFrame: Baseline and 6 weeks after the start of intervention
measure: Change from Baseline in Visual Memory as Assessed by the Benton Visual Retention Test - Form F at 6 Weeks
timeFrame: Baseline and 6 weeks after the intervention
measure: Change from Baseline in Working Memory Performance as Assessed by the Digit Span Test at 6 Weeks
timeFrame: Baseline and 6 weeks after the intervention
measure: Change from Baseline in Executive Function as Assessed by the Wisconsin Card Sorting Test (WCST) at 6 Weeks
timeFrame: Baseline and 6 weeks after the intervention
measure: Change from Baseline in Upper Extremity Motor Function as Assessed by the Fugl-Meyer Assessment of Upper Extremity (FMA-UE) at 6 Weeks
timeFrame: Baseline and 6 weeks after the start of intervention
Secondary outcomes:
measure: Change from Baseline in Balance Performance as Assessed by the Berg Balance Scale (BBS) at 6 Weeks
timeFrame: Baseline and 6 weeks after the start of intervention
measure: Change from Baseline in Motor Recovery Assessed by Brunnstrom Staging at 6 Weeks
timeFrame: Baseline and 6 weeks after the start of intervention
measure: Change from Baseline in Spatial Neglect Severity as Assessed by the Star Cancellation Test at 6 Weeks
timeFrame: Baseline and 6 weeks (only for participants with spatial neglect at baseline)
Other outcomes:
measure: Virtual Reality Sickness Score After First Session as Assessed by the Virtual Reality Sickness Questionnaire (VRSQ)
timeFrame: After first VR session (Week 1)
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Aydin University VM Medical Park Hospital
Study officials:
affiliation: Bahçeşehir University
name: Selen GÜR ÖZMEN, Associate Professor
role: STUDY_DIRECTOR
References: