NCT03778398

Brief Summary

Purpose of the study;

  • To improve the upper extremity motor functions of patients with adolescent cerebral palsy,
  • Prevent treatment interruptions as age progresses,
  • Increase the hand functions of children with cerebral palsy and to increase their living standards. Hand functions will be assessed with MACS (Manual Ability Classification System), hand dynamometer, box-block test, 9 hole peg test, pressing velocity measured with Cubase MIDI (musical instrument data interface) program. Patients will receive 2 days of 40 minutes per week, total 3 months of customized piano training. Each session will be started with finger warming exercises, then with the right hand, left handed and with both hands, a simple pentatonic array will be played. In the following lessons, notes will be marked with colors and simple songs will be taught. At the end of 3 months, the tests will be repeated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

1.6 years

First QC Date

December 2, 2018

Last Update Submit

December 14, 2018

Conditions

Keywords

music therapycerebral palsypiano training

Outcome Measures

Primary Outcomes (4)

  • Improved hand function

    Improvement on MACS (Manual Ability Classification System)

    3 months

  • Improved hand strength

    Improvement on hand dynamometer and pressing velocities measured by Cubase MIDI (musical instrument data interface) program

    3 months

  • Improved fine motor skills

    Improvement on box-block test

    3 months

  • Improved fine motor skills

    Improvement on 9 hole peg test

    3 months

Secondary Outcomes (1)

  • Improved hand coordination

    3 months

Study Arms (1)

Neurologic music therapy

EXPERIMENTAL

Patients will receive 2 days of 40 minutes per week, total 3 months of customized piano training. Each session will be started with finger warming exercises, then with the right hand, left handed and with both hands, a simple pentatonic array will be played. In the following lessons, notes will be marked with colors and simple songs will be taught.

Other: Neurologic music therapy

Interventions

Customized piano training

Neurologic music therapy

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Being 11-18 years old
  • To be diagnosed with cerebral palsy
  • Not have been previously trained piano
  • To have enough cognitive function to perform commands
  • Accepted to participate in the study

You may not qualify if:

  • Having cognitive disorder
  • Advanced visual impairment, visual field defect
  • To be previously trained for piano
  • Another disease preventing upper extremity movements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department

Istanbul, 34732, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Bilinç Doğruöz Karatekin, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Research Assistant of PMR

Study Record Dates

First Submitted

December 2, 2018

First Posted

December 19, 2018

Study Start

June 20, 2018

Primary Completion

February 1, 2020

Study Completion

March 20, 2020

Last Updated

December 19, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations