Examining the Effect of Piano Playing Training on Fine Motor Skills in Parkinson's Patients

November 1, 2023 updated by: Jason Friedman, Tel Aviv University
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel, 6997801
        • Tel Aviv University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Idiopathic Parkinson's Disease patients
  • Hoehn and Yahr stages I to III
  • Self-reports of some dexterity difficulties

Exclusion Criteria:

  • 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
  • Significant sensory deficits, e.g., hearing or sight impairment
  • Unstable medical disorder
  • Significant postural or action tremor, moderate dyskinesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Research group
Receives the full piano training
Behavioral: Piano
Receives the piano training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
First meeting, last meeting (after 6 weeks)
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
First meeting, last meeting (after 6 weeks)
Synergy index
Time Frame: First meeting, last meeting (after 6 weeks)
Calculated from a force ramp production task using the fingers with force sensors
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
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.
First meeting, last meeting (after 6 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quantitative Digitography - Average strike duration
Time Frame: First meeting, last meeting (after 6 weeks)
Measure of speed and variability of key presses on a piano - mean of the time the key is pressed
First meeting, last meeting (after 6 weeks)
Quantitative Digitography - Coefficient of variation strike duration
Time Frame: First meeting, last meeting (after 6 weeks)
Measure of speed and variability of key presses on a piano - coefficient of variation of the time the key is pressed
First meeting, last meeting (after 6 weeks)
Quantitative Digitography - Average interval between strikes (in seconds)
Time Frame: First meeting, last meeting (after 6 weeks)
Measure of speed and variability of key presses on a piano - average time between subsequent key presses
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)
Measure of speed and variability of key presses on a piano - coefficient of variation of the time between subsequent key presses
First meeting, last meeting (after 6 weeks)
Quantitative assessment of piano performance progress
Time Frame: First meeting, last meeting (after 6 weeks)
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.
First meeting, last meeting (after 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tel Aviv University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 22, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 8407-21-SMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymous raw data from the tests will be made available on figshare

IPD Sharing Time Frame

Upon publication

IPD Sharing Access Criteria

Open to all

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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