Parkinson DiseaseNCT06120192
Examining the Effect of Piano Playing Training on Fine Motor Skills in Parkinson's Patients
A study testing Piano in people with Parkinson Disease, run by Tel Aviv University at 1 site in Israel.
Trial summary
Piano playing may provide an engaging and accessible setting for finger and wrist movement training. Moreover, it has been found effective for improving manual dexterity and upper-limb function in other neurologic disorders, such as stroke and additionally beneficial for cognitive and psychosocial support in… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Piano
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Aug 2022to 31 Dec 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's Disease patients
- Hoehn and Yahr stages I to III
- Self-reports of some dexterity difficulties
Who cannot join
- Participation in an ongoing clinical study or clinical study within 30 days prior to this study
- Atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease, or other degenerative disease), or other neurologic conditions influencing upper limb movement
- Significant psychiatric symptoms or history
- Significant or recent experience in piano playing (participants who are proficient piano players, or had studied piano for more than 3 years in the past, or for shorter periods in the last 5 years)
- Other significant fine motor skills (e.g., high proficiency in playing another musical instrument, video games, etc.)
- Mini Mental status examination (MMSE) score below 25
Show all 9Show fewer
- Significant sensory deficits, e.g., hearing or sight impairment
- Unstable medical disorder
- Significant postural or action tremor, moderate dyskinesia
Trial locations and contacts
1 site in 1 country.
About this study
Piano playing may provide an engaging and accessible setting for finger and wrist movement training. Moreover, it has been found effective for improving manual dexterity and upper-limb function in other neurologic disorders, such as stroke and additionally beneficial for cognitive and psychosocial support in Parkinson's disease. However, no study has examined the effect of piano playing on dexterity in Parkinson's disease. The aim of this study is to test the efficacy of a novel piano-based training program on fine motor function in patients with PD. Participants with Parkinson's disease will take part in an individually tailored 6-week piano training program, combining weekly supervised training sessions (6x60 min altogether), with three independent at-home weekly 30 minutes practice sessions (18x30 altogether). Participants will receive a piano MIDI keyboard for home use during the study.
- Conditions
- Parkinson Disease
- Being tested
- Piano
- Keywords
- music, piano, dexterity
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PianoBehavioural
Receives the piano training
| Study group | Role | What they receive |
|---|---|---|
| Research group | Experimental | Receives the full piano training Receives: Behavioral: Piano |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and block test
Number of blocks that can be moved over a barrier using the hand / arm in one minute
Measured: First meeting, last meeting (after 6 weeks)
9 Hole peg test
Time taken to insert 9 pegs into holes and then remove them
Measured: First meeting, last meeting (after 6 weeks)
Synergy index
Calculated from a force ramp production task using the fingers with force sensors
Measured: First meeting, last meeting (after 6 weeks)
Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor parts II (patient questionnaire) - parts 2.4 to 2.7 and III (motor examination) - parts 3.3 and 3.4
Standard questionnaire used in Parkinson's disease. Higher scores indicate more impairment. Maximum score for each part is 4, so overall for the 6 parts the maximum score is 24.
Measured: First meeting, last meeting (after 6 weeks)
Secondary outcomes (5)
Quantitative Digitography - Average strike duration
Measure of speed and variability of key presses on a piano - mean of the time the key is pressed
Measured: First meeting, last meeting (after 6 weeks)
Quantitative Digitography - Coefficient of variation strike duration
Measure of speed and variability of key presses on a piano - coefficient of variation of the time the key is pressed
Measured: First meeting, last meeting (after 6 weeks)
Quantitative Digitography - Average interval between strikes (in seconds)
Measure of speed and variability of key presses on a piano - average time between subsequent key presses
Measured: First meeting, last meeting (after 6 weeks)
Quantitative Digitography - Coefficient of variation of interval between strikes
Measure of speed and variability of key presses on a piano - coefficient of variation of the time between subsequent key presses
Measured: First meeting, last meeting (after 6 weeks)
Quantitative assessment of piano performance progress
Measurement of improvement in playing the piano - the teacher (rater) will give a score (between 0 and 5) for the level of piano playing of the participant, where 0 is no ability to play and 5 is the ability to play the pieces from the workbook (a beginner's level piano book) perfectly.
Measured: First meeting, last meeting (after 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start22 Aug 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: Lack of staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label feasibility study
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Sheba Medical Center
- Responsible party
- Principal investigator, Jason Friedman, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120192
- Sponsor's protocol ID
- 8407-21-SMC
- Status last verified
- Nov 2023
- First submitted
- 26 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous raw data from the tests will be made available on figshare
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Piano Playing Training on Fine Motor Skills in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT06120192
- Acronym / sponsor ID
- 8407-21-SMC
- Conditions
- Parkinson Disease
- Keywords
- music, piano, dexterity
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Lack of staff
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Sheba Medical Center
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Nov 2023 (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.
Piano playing may provide an engaging and accessible setting for finger and wrist movement training. Moreover, it has been found effective for improving manual dexterity and upper-limb function in other neurologic disorders, such as stroke and additionally beneficial for cognitive and psychosocial support in Parkinson's disease. However, no study has examined the effect of piano playing on dexterity in Parkinson's disease. The aim of this study is to test the efficacy of a novel piano-based training program on fine motor function in patients with PD. Participants with Parkinson's disease will take part in an individually tailored 6-week piano training program, combining weekly supervised training sessions (6x60 min altogether), with three independent at-home weekly 30 minutes practice sessions (18x30 altogether). Participants will receive a piano MIDI keyboard for home use during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label feasibility study
| Arm | Type | Receives |
|---|---|---|
| Research group | Experimental | Behavioral: PianoReceives the full piano training |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic Parkinson's Disease patients
- Hoehn and Yahr stages I to III
- Self-reports of some dexterity difficulties
Key exclusion criteria (9 listed)
- Participation in an ongoing clinical study or clinical study within 30 days prior to this study
- Atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease, or other degenerative disease), or other neurologic conditions influencing upper limb movement
- Significant psychiatric symptoms or history
- Significant or recent experience in piano playing (participants who are proficient piano players, or had studied piano for more than 3 years in the past, or for shorter periods in the last 5 years)
- Other significant fine motor skills (e.g., high proficiency in playing another musical instrument, video games, etc.)
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 |
|---|---|---|
| PianoReceives the piano training | Behavioural | Research group |
Primary outcome
Box and block test
Time frame: First meeting, last meeting (after 6 weeks)
Number of blocks that can be moved over a barrier using the hand / arm in one minute
9 Hole peg test
Time frame: First meeting, last meeting (after 6 weeks)
Time taken to insert 9 pegs into holes and then remove them
Synergy index
Time frame: First meeting, last meeting (after 6 weeks)
Calculated from a force ramp production task using the fingers with force sensors
Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor parts II (patient questionnaire) - parts 2.4 to 2.7 and III (motor examination) - parts 3.3 and 3.4
Time frame: First meeting, last meeting (after 6 weeks)
Standard questionnaire used in Parkinson's disease. Higher scores indicate more impairment. Maximum score for each part is 4, so overall for the 6 parts the maximum score is 24.
5 secondary outcomes
Quantitative Digitography - Average strike duration
Time frame: First meeting, last meeting (after 6 weeks)
Quantitative Digitography - Coefficient of variation strike duration
Time frame: First meeting, last meeting (after 6 weeks)
Quantitative Digitography - Average interval between strikes (in seconds)
Time frame: First meeting, last meeting (after 6 weeks)
Quantitative Digitography - Coefficient of variation of interval between strikes
Time frame: First meeting, last meeting (after 6 weeks)
Quantitative assessment of piano performance progress
Time frame: First meeting, last meeting (after 6 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Yes. Anonymous raw data from the tests will be made available on figshare
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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 Piano in people with Parkinson Disease, run by Tel Aviv University at 1 site in Israel.
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 3 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: paused, as of the sponsor's last update on 7 Nov 2023. 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 Israel. 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?
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?
Box and block test (time frame: First meeting, last meeting (after 6 weeks)). The study lists 4 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 7 Nov 2023.