NCT06120192

Brief 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 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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
3

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

2.4 years

First QC Date

October 26, 2023

Last Update Submit

November 1, 2023

Conditions

Keywords

musicpianodexterity

Outcome Measures

Primary Outcomes (4)

  • Box and block test

    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 taken to insert 9 pegs into holes and then remove them

    First meeting, last meeting (after 6 weeks)

  • Synergy index

    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

    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 Outcomes (5)

  • Quantitative Digitography - Average strike duration

    First meeting, last meeting (after 6 weeks)

  • Quantitative Digitography - Coefficient of variation strike duration

    First meeting, last meeting (after 6 weeks)

  • Quantitative Digitography - Average interval between strikes (in seconds)

    First meeting, last meeting (after 6 weeks)

  • Quantitative Digitography - Coefficient of variation of interval between strikes

    First meeting, last meeting (after 6 weeks)

  • Quantitative assessment of piano performance progress

    First meeting, last meeting (after 6 weeks)

Study Arms (1)

Research group

EXPERIMENTAL

Receives the full piano training

Behavioral: Piano

Interventions

PianoBEHAVIORAL

Receives the piano training

Research group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv University

Tel Aviv, 6997801, Israel

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open label feasibility study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 26, 2023

First Posted

November 7, 2023

Study Start

August 22, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

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

Shared Documents
ICF
Time Frame
Upon publication
Access Criteria
Open to all

Available IPD Datasets

Informed Consent Form (10.6084/m9.figshare.23994768)Access
Individual Participant Data Set (10.6084/m9.figshare.23994768)Access

Locations