Health PeopleNCT06378411
Development and Application of a Musical Game for Motor Rehabilitation
A study testing Music Game Intervention in people with Health People and Survivors of Stroke, run by Universidade da Madeira at 1 site in Portugal.
Trial summary
The aim of this study is to develop, adapt a musical game for residents of RAM, and evaluated the usability and correlation between this game with the improvement of motor coordination in short time. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health People, Survivors of Stroke
- What is being tested?
- Music Game Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePortugal
- Study dates
- 4 Apr 2024to Oct 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Health people
- Survivors of Stroke
Who cannot join
- Dementia
- Visual Defict
- People who already knows how to play piano
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Universidade da Madeira
Funchal
Yasmim Moniz, Master, +351 968412551, yasmimfernandes08@hotmail.com
yasmimfernandes08@hotmail.com
About this study
The aim of this study is to develop, adapt a musical game for residents of RAM, and evaluated the usability and correlation between this game with the improvement of motor coordination in short time.
- Conditions
- Health People, Survivors of Stroke
- Being tested
- Music Game Intervention
- Keywords
- music intervention, rehabilitation, stroke, motor coordination, adults
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Game InterventionDevice
Also called Music Based Intervention
Use of music to induce improvements in cognitive and motor outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Music Game Group | Experimental | Use of Moniz Game with digital interface Receives: Device: Music Game Intervention |
| Music Game Controller Group | Experimental | Use of Moniz Game with piano controller Receives: Device: Music Game Intervention |
| Music Practice Group | Active comparator | Use of music trainning as intervention Receives: Device: Music Game Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Coordination
Motor Performance by time
Measured: 1 month
Usability
Evaluated the quality with the facility to use the system
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start4 Apr 2024
- Primary completionJul 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health PeopleStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade da Madeira
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmim Fernandes Moniz, Universidade da Madeira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378411
- Sponsor's protocol ID
- P109
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of a Musical Game for Motor Rehabilitation
- ClinicalTrials.gov ID
- NCT06378411
- Acronym / sponsor ID
- P109
- Conditions
- Health People, Survivors of Stroke
- Keywords
- music intervention, rehabilitation, stroke, motor coordination, adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universidade da MadeiraUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 22 Apr 2024 (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 aim of this study is to develop, adapt a musical game for residents of RAM, and evaluated the usability and correlation between this game with the improvement of motor coordination in short time.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Music Game Group | Experimental | Device: Music Game InterventionUse of Moniz Game with digital interface |
| Music Game Controller Group | Experimental | Device: Music Game InterventionUse of Moniz Game with piano controller |
| Music Practice Group | Active comparator | Device: Music Game InterventionUse of music trainning as intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Health people
- Survivors of Stroke
Key exclusion criteria (3 listed)
- Dementia
- Visual Defict
- People who already knows how to play piano
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 |
|---|---|---|
| Music Game InterventionAlso: Music Based InterventionUse of music to induce improvements in cognitive and motor outcomes. | Device | Music Game Controller Group, Music Game Group, Music Practice Group |
Primary outcome
Motor Coordination
Time frame: 1 month
Motor Performance by time
Usability
Time frame: 20 minutes
Evaluated the quality with the facility to use the system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Game Intervention in people with Health People and Survivors of Stroke, run by Universidade da Madeira at 1 site in Portugal.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Apr 2024. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Coordination (time frame: 1 month). The study lists 2 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 22 Apr 2024.