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StrokeNCT07010536

Effect of Virtual Reality-Based Music Therapy on Cognitive and Motor Skills in Subacute Stroke Patients

A study testing VR-Based Music Therapy and Conventional Physiotherapy and Rehabilitation in people with Stroke and Subacute Stroke, run by Suzan Aydın at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Stroke, Subacute Stroke, Virtual Reality
What is being tested?
VR-Based Music Therapy and Conventional Physiotherapy and Rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2025to 20 Aug 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 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Epilepsy
  • Migraine with aura
  • History of motion sickness

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Aydin University VM Medical Park Hospital

    Istanbul, Istanbul, 34149

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Immersive Virtual Reality-Based Music Therapy on Cognitive and Motor Skills in Subacute Stroke Patients

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.

Read the 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.

Being tested
VR-Based Music Therapy, Conventional Physiotherapy and Rehabilitation
Keywords
Stroke, Music Therapy, Virtual Reality, Cognition Disorders, Motor Skills Disorders, Postural Balance
Medical subject headings
Stroke, Cognitive Dysfunction, Cognition Disorders, Motor Skills Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VR-Based Music TherapyBehavioural

    VR-Based Music Therapy Protocol:

    Participants undergo immersive VR sessions twice weekly for 6 weeks, each lasting 30 minutes, supervised by a physiotherapist. Each session includes three 10-minute activities with 2-minute breaks:

    Rhythm Exercises: Participants follow tempo by clapping on a table while watching Brooklyn Music Factory YouTube videos played within the VR headset (levels 1-4), progressing weekly.

    Ocean Rift: Exploration of calming underwater environments with marine life to enhance relaxation, attention, and cognition.

    PianoVision: Virtual piano exercises using hand tracking with the unaffected hand; difficulty increases from levels 0 to 4.

  • Conventional Physiotherapy and RehabilitationBehavioural

    Participants will receive conventional physiotherapy and rehabilitation exercises as follows:

    Upper and lower extremity strengthening exercises

    Resistance training exercises

    Aerobic exercises

    Basic and assisted parallel bar walking

    Skill courses on various surfaces

    Training on stable and unstable surfaces

    Static and dynamic balance exercises

    Fine motor skill exercises

    Weight transfer exercises to improve postural stability

    Exercises will be performed according to the patient's condition in standing, sitting, four-point kneeling, supine, and prone positions.

    Exercise difficulty will be adjusted based on the patient's performance and functional level.

    Sessions will be 60 minutes long, 5 days per week, for 6 weeks.

Study groups in NCT07010536
Study groupRoleWhat they receive
Conventional Physiotherapy and Rehabilitation GroupActive comparatorParticipants in the control arm will receive conventional physiotherapy and rehabilitation exercises five days per week for six weeks, with sessions lasting approximately 60 minutes. The program includes: Strengthening exercises for upper and lower extremities Resistance training Aerobic exercises Basic and assisted parallel bar walking Skill courses on different surfaces Balance exercises on stable and unstable surfaces Static and dynamic balance training Fine motor skill exercises Weight transfer exercises aimed at improving postural stability Exercises will be tailored to individual patient capabilities and performed in various positions including standing, sitting, four-point kneeling, supine, and prone. The difficulty level will be adjusted based on patient performance and functional status.
Receives: Behavioral: Conventional Physiotherapy and Rehabilitation
VR-Based Music Therapy GroupExperimentalParticipants in the experimental arm will receive conventional physiotherapy and rehabilitation exercises five days per week for six weeks, each session lasting approximately 60 minutes. In addition to this, they will undergo immersive virtual reality (VR)-based music therapy sessions twice a week for 30 minutes per session over the same six-week period. The VR therapy is administered under the supervision of a licensed physiotherapist using the Oculus Quest 2 headset. The intervention includes three main components: Rhythm Exercises: Participants will engage in rhythm training by following clapping patterns streamed from the Brooklyn Music Factory YouTube channel, progressing from levels 1 to 4. During these exercises, participants clap their hands on a table to maintain the rhythm, which aims to improve motor coordination and timing. PianoVision Application: A virtual piano that utilizes hand-tracking technology to allow participants to play without physical controllers. The pian
Receives: Behavioral: VR-Based Music Therapy; Behavioral: Conventional Physiotherapy and Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Global Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA) at 6 Weeks

    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.

    Measured: Baseline and 6 weeks after the start of intervention

  2. Change from Baseline in Visual Memory as Assessed by the Benton Visual Retention Test - Form F at 6 Weeks

    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.

    Measured: Baseline and 6 weeks after the intervention

  3. Change from Baseline in Working Memory Performance as Assessed by the Digit Span Test at 6 Weeks

    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.

    Measured: Baseline and 6 weeks after the intervention

  4. Change from Baseline in Executive Function as Assessed by the Wisconsin Card Sorting Test (WCST) at 6 Weeks

    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.

    Measured: Baseline and 6 weeks after the intervention

  5. Change from Baseline in Upper Extremity Motor Function as Assessed by the Fugl-Meyer Assessment of Upper Extremity (FMA-UE) at 6 Weeks

    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.

    Measured: Baseline and 6 weeks after the start of intervention

Secondary outcomes (3)
  1. Change from Baseline in Balance Performance as Assessed by the Berg Balance Scale (BBS) at 6 Weeks

    Balance performance will be assessed using the Berg Balance Scale (BBS), a validated tool to evaluate static and dynamic balance in individuals with stroke. The BBS consists of 14 tasks related to postural control and risk of falling. Each task is scored on a 5-point scale from 0 to 4, with a total score ranging from 0 to 56. Higher scores indicate better balance and lower risk of falls. Assessments will be conducted at baseline and 6 weeks post-intervention to evaluate changes in balance following immersive virtual reality-based music therapy.

    Measured: Baseline and 6 weeks after the start of intervention

  2. Change from Baseline in Motor Recovery Assessed by Brunnstrom Staging at 6 Weeks

    Brunnstrom Staging is used to evaluate motor recovery stages in stroke patients, assessing movement patterns and motor control progression. This measure will assess motor function improvements following immersive virtual reality-based music therapy. Assessments will be conducted at baseline and 6 weeks post-intervention.

    Measured: Baseline and 6 weeks after the start of intervention

  3. Change from Baseline in Spatial Neglect Severity as Assessed by the Star Cancellation Test at 6 Weeks

    Spatial neglect will be screened using the Star Cancellation Test (SCT), a validated subtest of the Behavioral Inattention Test (BIT). Participants are asked to cancel 54 small stars among distractor stimuli on a printed page. The total score is based on the number of correctly cancelled small stars. Scores range from 0 to 54, with scores of 43 or below indicating the presence of spatial neglect. Lower scores indicate more severe neglect. The test will be administered to all participants at baseline. Participants who score ≤43 will be considered to have spatial neglect, and for these individuals the test will be repeated at 6 weeks to evaluate change. Participants who do not meet the cutoff at baseline will not be retested.

    Measured: Baseline and 6 weeks (only for participants with spatial neglect at baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2025
  2. Study start1 May 2025
  3. Primary completion20 Jul 2025
  4. Study completion20 Aug 2025

Resources

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
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07010536
Sponsor's protocol ID
61351342/020-1000
Status last verified
Oct 2026
First submitted
21 May 2025
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We plan to share all individual participant data (IPD) collected throughout the trial, including baseline characteristics, intervention details, outcome measures, and adverse events. The data will be de-identified to protect participant privacy and made available upon reasonable request to qualified researchers following publication of the main results.

Questions about this trial

What is this clinical trial studying?

A study testing VR-Based Music Therapy and Conventional Physiotherapy and Rehabilitation in people with Stroke and Subacute Stroke, run by Suzan Aydın at 1 site in Turkey (Türkiye).

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 5 inclusion and 9 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 8 Oct 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 Turkey (Türkiye). 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 from Baseline in Global Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA) at 6 Weeks (time frame: Baseline and 6 weeks after the start of intervention). The study lists 5 primary outcomes in all. 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 8 Oct 2026.

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