Cerebral PalsyHARMONY-CPNCT07596550
Comparative Study of Augmented Reality and Virtual Reality in Music Therapy Interventions for Individuals With Cerebral Palsy
A study testing Augmented Reality Music Therapy Using GenVirtual and Virtual Reality Music Therapy Using GenVirtual in people with Cerebral Palsy, run by Mackenzie Presbiterian University at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to compare the user experience of Augmented Reality (AR) and Virtual Reality (VR) applications during music therapy interventions in individuals with Cerebral Palsy aged 15 to 35 years with Gross Motor Function Classification System (GMFCS) level I-V. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Augmented Reality Music Therapy Using GenVirtual and Virtual Reality Music Therapy Using GenVirtual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2026to 30 Sep 2026
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals with a confirmed diagnosis of Cerebral Palsy
- Aged between 15 and 35 years
- Participants of any sex
- Cognitive ability compatible with participation in the study, determined by a minimum Intelligence Quotient (IQ) score established through the Wechsler Intelligence Scale for Children (WISC) or Wechsler Adult Intelligence Scale (WAIS)
- Ability to participate in immersive music therapy activities using hand-tracking interaction with the Meta Quest 3 headset
Who cannot join
- Failure to attend the second experimental session
- Withdrawal or interruption of participation in the study for any reason before completion of all study procedures
- Insufficient corrected visual acuity to adequately interact with the immersive system, verified through a simple visual screening assessment
- Failure to achieve the minimum Intelligence Quotient (IQ) score required for understanding the proposed tasks, as determined by the Wechsler Intelligence Scale for Children (WISC) or Wechsler Adult Intelligence Scale (WAIS) assessments
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to compare the user experience of Augmented Reality (AR) and Virtual Reality (VR) applications during music therapy interventions in individuals with Cerebral Palsy aged 15 to 35 years with Gross Motor Function Classification System (GMFCS) level I-V.
The main questions it aims to answer are:
Read more
Does AR or VR result in lower levels of cybersickness as measured by the Simulator Sickness Questionnaire (SSQ)? Does AR or VR provide better usability, preference, and perceived ease of interaction?
Researchers will compare AR and VR conditions to determine which technology results in lower cybersickness levels, higher usability scores, and greater user preference.
Participants will:
complete a pre-intervention SSQ assessment; engage in AR and VR sessions in a counterbalanced order using the Meta Quest 3 headset; explore each virtual environment for 5 minutes; perform motor tasks involving reaching and interacting with virtual musical objects (musical cubes representing musical notes: C-D-E-F-G-A-B); perform cognitive tasks involving identification and reproduction of musical note sequences guided by a therapist; perform percussion activities by following rhythmic patterns played by a therapist using virtual instruments; complete post-condition assessments after each session, including SSQ, System Usability Scale (SUS), preference, and reported difficulties.
Read the detailed description
This study investigates the use of immersive technologies in music therapy for individuals with Cerebral Palsy, focusing on the comparative effects of Augmented Reality (AR) and Virtual Reality (VR) on user experience and interaction.
Individuals classified at Gross Motor Function Classification System (GMFCS) level I-V often present severe motor impairments that limit their ability to engage in conventional therapeutic activities. Music therapy has been shown to support cognitive and emotional engagement; however, traditional approaches may require adaptations to accommodate motor limitations. Immersive technologies such as AR and VR offer alternative interaction modalities that may enhance accessibility, engagement, and autonomy.
The study adopts a within-subject crossover design in which all participants are exposed to both AR and VR conditions in a counterbalanced order to minimize sequence effects. The experimental sessions are conducted on separate days, with one condition (AR or VR) performed first and the alternate condition performed approximately one week later to minimize carryover effects.
The intervention is delivered using the Meta Quest 3 headset, which supports hand-tracking interaction. A custom application, named GenVirtual, was developed in the Unity 3D environment to provide accessible and adaptive interaction for individuals with severe motor impairments. The system leverages hand-tracking to enable interaction without the need for physical controllers, reducing barriers related to fine motor control.
Each experimental session is structured into three phases: (1) initial familiarization with the immersive environment, (2) interaction with musical cubes representing musical notes, and (3) rhythmic interaction using virtual percussion instruments. The musical cubes are visually differentiated by color and correspond to the seven musical notes (C-D-E-F-G-A-B), allowing participants to perform structured tasks involving sequencing and auditory discrimination. In the percussion phase, participants reproduce rhythmic patterns demonstrated by a therapist, promoting synchronization, attention, and sensorimotor coordination.
The applications were designed to support both motor and cognitive engagement by integrating multimodal feedback (visual and auditory cues) and minimizing the need for precise fine motor control. The therapist provides guidance throughout the session, ensuring task comprehension and adapting the pace as needed based on participant performance.
Data collection focuses on subjective measures of user experience, including perceived usability, cybersickness symptoms, and interaction-related difficulties. The crossover design allows for direct comparison between AR and VR conditions within the same participants, reducing inter-subject variability and increasing sensitivity to detect differences between technologies.
- Conditions
- Cerebral Palsy
- Being tested
- Augmented Reality Music Therapy Using GenVirtual, Virtual Reality Music Therapy Using GenVirtual
- Keywords
- Cerebral Palsy, Augmented Reality, Virtual Reality, Mixed Reality, Music Therapy, User Experience, Usability, Cybersickness, System Usability Scale, Meta Quest 3, Motor Rehabilitation, Assistive Technology, Accessibility, Human-Computer Interaction
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Reality Music Therapy Using GenVirtualDevice
Augmented reality-based music therapy activities delivered through the GenVirtual application, developed in Unity 3D and used with the Meta Quest 3 headset with hand-tracking interaction. Participants interact with virtual musical cubes and percussion instruments through reaching movements and hand-based interaction.
Virtual Reality Music Therapy Using GenVirtualDevice
Virtual reality-based music therapy activities delivered through the GenVirtual application, developed in Unity 3D and used with the Meta Quest 3 headset with hand-tracking interaction. Participants interact with virtual musical cubes and percussion instruments through reaching movements and hand-based interaction.
| Study group | Role | What they receive |
|---|---|---|
| Augmented Reality (AR) Music Therapy | Experimental | Participants engage in music therapy activities using an augmented reality environment (GenVirtual) and delivered through the Meta Quest 3 with hand tracking. Activities include interaction with musical cubes and virtual percussion tasks designed to reduce fine motor demands and promote engagement. Receives: Device: Augmented Reality Music Therapy Using GenVirtual |
| Virtual Reality (VR) Music Therapy | Experimental | Participants engage in music therapy activities using an virtual reality environment (GenVirtual) and delivered through the Meta Quest 3 with hand tracking. Activities include interaction with musical cubes and virtual percussion tasks designed to reduce fine motor demands and promote engagement. Receives: Device: Virtual Reality Music Therapy Using GenVirtual |
What is being measured
The primary outcome is the main question the study is designed to answer.
User experience and usability of AR and VR environments
User experience will be assessed through an adapted version of the System Usability Scale (SUS) and additional user-reported measures of interaction quality, ease of use, and confidence. The assessment captures perceived usability, learnability, need for assistance, and overall satisfaction with the system during interaction in both Augmented Reality (AR) and Virtual Reality (VR) conditions.
Measured: Immediately after AR session and immediately after VR session
Secondary outcomes (4)
Cybersickness symptoms (adapted symptom scale)
Symptoms of cybersickness will be assessed using a self-reported symptom scale adapted from the Simulator Sickness Questionnaire (SSQ), including dizziness, nausea, fatigue, blurred vision, sweating, anxiety, and discomfort. Each symptom is rated on a scale of 0 to 10 (0 = none, 10 = maximum). The measurements will be used to compare the variation in symptoms between AR and VR conditions.
Measured: Baseline, immediately after the AR session, and immediately after the VR session
Physical comfort and interaction quality (ISO 9241-400-based measures)
Physical comfort, effort, fatigue, precision, and interaction quality will be assessed using items adapted from ISO 9241-400 guidelines. The instrument evaluates posture comfort, physical effort during hand-tracking interaction, naturalness of movements, system responsiveness, and interaction consistency.
Measured: Immediately after AR session and immediately after VR session
User preference between AR and VR conditions
Participant preference will be assessed after exposure to both conditions. Participants will indicate which environment (AR or VR) they preferred based on overall experience.
Measured: Immediately after completion of both intervention sessions
Reported difficulties and qualitative feedback
Participants will report perceived difficulties, frustration points, and positive aspects of interaction through structured questions and brief interviews. Additional observational notes from therapists may be recorded to identify usability barriers and interaction challenges.
Measured: Immediately after completion of both intervention sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Jun 2026
- Primary completion30 Aug 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will complete both intervention conditions, Augmented Reality (AR) and Virtual Reality (VR), in a counterbalanced crossover design. The order of exposure will be alternated across participants to minimize sequence effects. The two experimental sessions will be conducted on separate days, approximately one week apart, with each participant serving as their own control for comparison of user experience, usability, cybersickness, preference, and reported difficulties.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackenzie Presbiterian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Grasielle Dionísio Corrêa, Mackenzie Presbiterian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596550
- Sponsor's protocol ID
- 91871425.2.0000.0084
- Acronym
- HARMONY-CP
- Status last verified
- Oct 2026
- First submitted
- 6 May 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Augmented Reality and Virtual Reality in Music Therapy Interventions for Individuals With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07596550
- Acronym / sponsor ID
- HARMONY-CP / 91871425.2.0000.0084
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Augmented Reality, Virtual Reality, Mixed Reality, Music Therapy, User Experience, Usability, Cybersickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mackenzie Presbiterian UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the user experience of Augmented Reality (AR) and Virtual Reality (VR) applications during music therapy interventions in individuals with Cerebral Palsy aged 15 to 35 years with Gross Motor Function Classification System (GMFCS) level I-V.
The main questions it aims to answer are:
Does AR or VR result in lower levels of cybersickness as measured by the Simulator Sickness Questionnaire (SSQ)? Does AR or VR provide better usability, preference, and perceived ease of interaction?
Researchers will compare AR and VR conditions to determine which technology results in lower cybersickness levels, higher usability scores, and greater user preference.
Participants will:
complete a pre-intervention SSQ assessment; engage in AR and VR sessions in a counterbalanced order using the Meta Quest 3 headset; explore each virtual environment for 5 minutes; perform motor tasks involving reaching and interacting with virtual musical objects (musical cubes representing musical notes: C-D-E-F-G-A-B); perform cognitive tasks involving identification and reproduction of musical note sequences guided by a therapist; perform percussion activities by following rhythmic patterns played by a therapist using virtual instruments; complete post-condition assessments after each session, including SSQ, System Usability Scale (SUS), preference, and reported difficulties.
Detailed description
This study investigates the use of immersive technologies in music therapy for individuals with Cerebral Palsy, focusing on the comparative effects of Augmented Reality (AR) and Virtual Reality (VR) on user experience and interaction.
Individuals classified at Gross Motor Function Classification System (GMFCS) level I-V often present severe motor impairments that limit their ability to engage in conventional therapeutic activities. Music therapy has been shown to support cognitive and emotional engagement; however, traditional approaches may require adaptations to accommodate motor limitations. Immersive technologies such as AR and VR offer alternative interaction modalities that may enhance accessibility, engagement, and autonomy.
The study adopts a within-subject crossover design in which all participants are exposed to both AR and VR conditions in a counterbalanced order to minimize sequence effects. The experimental sessions are conducted on separate days, with one condition (AR or VR) performed first and the alternate condition performed approximately one week later to minimize carryover effects.
The intervention is delivered using the Meta Quest 3 headset, which supports hand-tracking interaction. A custom application, named GenVirtual, was developed in the Unity 3D environment to provide accessible and adaptive interaction for individuals with severe motor impairments. The system leverages hand-tracking to enable interaction without the need for physical controllers, reducing barriers related to fine motor control.
Each experimental session is structured into three phases: (1) initial familiarization with the immersive environment, (2) interaction with musical cubes representing musical notes, and (3) rhythmic interaction using virtual percussion instruments. The musical cubes are visually differentiated by color and correspond to the seven musical notes (C-D-E-F-G-A-B), allowing participants to perform structured tasks involving sequencing and auditory discrimination. In the percussion phase, participants reproduce rhythmic patterns demonstrated by a therapist, promoting synchronization, attention, and sensorimotor coordination.
The applications were designed to support both motor and cognitive engagement by integrating multimodal feedback (visual and auditory cues) and minimizing the need for precise fine motor control. The therapist provides guidance throughout the session, ensuring task comprehension and adapting the pace as needed based on participant performance.
Data collection focuses on subjective measures of user experience, including perceived usability, cybersickness symptoms, and interaction-related difficulties. The crossover design allows for direct comparison between AR and VR conditions within the same participants, reducing inter-subject variability and increasing sensitivity to detect differences between technologies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will complete both intervention conditions, Augmented Reality (AR) and Virtual Reality (VR), in a counterbalanced crossover design. The order of exposure will be alternated across participants to minimize sequence effects. The two experimental sessions will be conducted on separate days, approximately one week apart, with each participant serving as their own control for comparison of user experience, usability, cybersickness, preference, and reported difficulties.
| Arm | Type | Receives |
|---|---|---|
| Augmented Reality (AR) Music Therapy | Experimental | Device: Augmented Reality Music Therapy Using GenVirtualParticipants engage in music therapy activities using an augmented reality environment (GenVirtual) and delivered through the Meta Quest 3 with hand tracking. Activities include interaction with musical cubes and virtual percussion tasks designed to reduce fine motor demands and promote engagement. |
| Virtual Reality (VR) Music Therapy | Experimental | Device: Virtual Reality Music Therapy Using GenVirtualParticipants engage in music therapy activities using an virtual reality environment (GenVirtual) and delivered through the Meta Quest 3 with hand tracking. Activities include interaction with musical cubes and virtual percussion tasks designed to reduce fine motor demands and promote engagement. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals with a confirmed diagnosis of Cerebral Palsy
- Aged between 15 and 35 years
- Participants of any sex
- Cognitive ability compatible with participation in the study, determined by a minimum Intelligence Quotient (IQ) score established through the Wechsler Intelligence Scale for Children (WISC) or Wechsler Adult Intelligence Scale (WAIS)
- Ability to participate in immersive music therapy activities using hand-tracking interaction with the Meta Quest 3 headset
Key exclusion criteria (4 listed)
- Failure to attend the second experimental session
- Withdrawal or interruption of participation in the study for any reason before completion of all study procedures
- Insufficient corrected visual acuity to adequately interact with the immersive system, verified through a simple visual screening assessment
- Failure to achieve the minimum Intelligence Quotient (IQ) score required for understanding the proposed tasks, as determined by the Wechsler Intelligence Scale for Children (WISC) or Wechsler Adult Intelligence Scale (WAIS) assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented Reality Music Therapy Using GenVirtualAugmented reality-based music therapy activities delivered through the GenVirtual application, developed in Unity 3D and used with the Meta Quest 3 headset with hand-tracking interaction. Participants interact with virtual musical cubes and percussion instruments through reaching movements and hand-based interaction. | Device | Augmented Reality (AR) Music Therapy |
| Virtual Reality Music Therapy Using GenVirtualVirtual reality-based music therapy activities delivered through the GenVirtual application, developed in Unity 3D and used with the Meta Quest 3 headset with hand-tracking interaction. Participants interact with virtual musical cubes and percussion instruments through reaching movements and hand-based interaction. | Device | Virtual Reality (VR) Music Therapy |
Primary outcome
User experience and usability of AR and VR environments
Time frame: Immediately after AR session and immediately after VR session
User experience will be assessed through an adapted version of the System Usability Scale (SUS) and additional user-reported measures of interaction quality, ease of use, and confidence. The assessment captures perceived usability, learnability, need for assistance, and overall satisfaction with the system during interaction in both Augmented Reality (AR) and Virtual Reality (VR) conditions.
4 secondary outcomes
Cybersickness symptoms (adapted symptom scale)
Time frame: Baseline, immediately after the AR session, and immediately after the VR session
Physical comfort and interaction quality (ISO 9241-400-based measures)
Time frame: Immediately after AR session and immediately after VR session
User preference between AR and VR conditions
Time frame: Immediately after completion of both intervention sessions
Reported difficulties and qualitative feedback
Time frame: Immediately after completion of both intervention sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality Music Therapy Using GenVirtual and Virtual Reality Music Therapy Using GenVirtual in people with Cerebral Palsy, run by Mackenzie Presbiterian University at 1 site in Brazil.
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 4 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 Brazil. 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?
User experience and usability of AR and VR environments (time frame: Immediately after AR session and immediately after VR session). 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.