The Effect of Music Therapy on Upper Extremity Functions and Quality Of Life in Individuals With Cerebral Palsy

January 6, 2024 updated by: Nezehat Özgül, Ankara Yildirim Beyazıt University
The main purpose of this study is to investigate the effect of music therapy on the upper extremity functions and quality of life of individuals with Cerebral Palsy (CP). The secondary aim is to investigate the effect of music therapy on the sensory functions of the upper extremity in individuals with CP. Adolescent individuals with hemiparetic CP will participate in this study, and the participants will experience music therapy, which is a scientific intervention approach. If music therapy has a positive effect on upper extremity functions, they will be more active in daily life and their quality of life will increase. In the light of these data to be presented, a contribution will be made to the evidence level of music therapy in the literature and to the content of SP upper extremity rehabilitation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • 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 Contact

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Sena ÇARIKCI
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sena ÇARIKCI, MSc

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

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Between the ages of 6-21
  • With upper extremity dysfunction
  • MACS score between 2-4,
  • According to MAS, spasticity severity ranges from (1+) to (3),
  • Individuals diagnosed with hemiparetic Cerebral Palsy who are at a cognitive level that can follow simple instructions during applications and evaluations will be included.

Exclusion Criteria:

  • Having another neurological disorder
  • Having undergone upper extremity orthopedic surgery or Botulinum Toxin A (BTX-A) application in the last 6 months,
  • Individuals currently receiving another rehabilitation program in addition to classical physiotherapy for upper extremity rehabilitation will be excluded from the study.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Classical physiotherapy program will be applied for gross motor functions and upper extremity functions.
Other: Control Group
The session is 50 minutes long and consists of 20 minutes of classical physiotherapy for gross motor functions and 30 minutes of classical physiotherapy for the upper extremity. A total of 16 sessions will be applied 2 days a week for 8 weeks.
Other Names:
  • Classical Physiotherapy
Experimental: Study (Music) Group
In addition to the classical physiotherapy program for gross motor functions, will be applied in the Neuro-Creative Music Therapy (NCMT) program for upper extremity.
Other: Study (Music) Group
The session is 50 minutes long and consists of 20 minutes of classical physiotherapy for gross motor functions and 30 minutes of music therapy for the upper extremity. A total of 16 sessions will be applied 2 days a week for 8 weeks.
Other Names:
  • Music Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Hand-Use Experience Questionnaire (CHEQ)
Time Frame: Change from baseline at 8 weeks
Children's Hand-Use Experience Questionnaire (CHEQ) is a scale that evaluates unilateral hand disorders in children due to various reasons (such as hemiparetic CP, brachial plexus or upper extremity developmental deficiency for any reason). CHEQ consists of 27 sub-items and evaluates quality aspects of movement in three different subscales, including the grasping efficiency of hand functions, the time required to perform the activity, and the feeling of discomfort caused by the affected hand during the performance of the activity.
Change from baseline at 8 weeks
Abilhand-Kids
Time Frame: Change from baseline at 8 weeks
Abilhand-Kids scale evaluates hand functions in children with CP. It measures the use of the upper extremity during children's daily activities in 21 items. There are 3 points in the scoring: 0: cannot be done, 1: difficult, 2: easy.
Change from baseline at 8 weeks
Selective Control of the Upper Extremity Scale (SCUES)
Time Frame: Change from baseline at 8 weeks
Selective Control of the Upper Extremity Scale (SCUES) is a measurement tool specifically designed for this area, developed to evaluate selective motor control of the upper extremity. It is a useful evaluation measure that is video-based and implemented in less than 15 minutes. The degree of selective motor control is determined for each joint as "normal selective motor control: 3 points, mildly reduced selective motor control: 2 points, moderately reduced selective motor control: 1 point, no selective motor control: 0 points".
Change from baseline at 8 weeks
Pediatric Quality of Life Inventory (PedsQL) 3.0 Cerebral Palsy Module
Time Frame: Change from baseline at 8 weeks
Pediatric Quality of Life Inventory (PedsQL) 3.0 Cerebral Palsy (CP) Module was developed to evaluate CP-specific quality of life areas of children with CP between the ages of 2-18. The scale questions the degree of problems experienced by individuals in the last month. The 35-item module consists of seven subscales: daily activities (9 items), school activities (4 items), movement and balance (5 items), pain and suffering (4 items), fatigue (4 items), eating activities (5 items), speech and communication (4 items). Subscale scores are calculated by dividing the total score of the answered items by the number of answered items. A higher mean score on a subscale of a field indicates that there are fewer problems in that field and the quality of life is higher.
Change from baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Semmes Weinstein Monofilament Test (SWMT)
Time Frame: Change from baseline at 8 weeks
Semmes Weinstein Monofilament Test (SWMT) is a tactile test battery recommended to evaluate tactile sensation in individuals with CP. The SWMT battery has five different thicknesses of monofilament ranging from 2.83 to 6.65. The evaluation starts with the thinnest (2.83) filament and continues until the monofilament that the individual begins to feel.
Change from baseline at 8 weeks
Two-Point Discrimination
Time Frame: Change from baseline at 8 weeks
Two-Point Discrimination is used to evaluate tactile perception in individuals with CP. It evaluates the ability to perceive and distinguish tactile stimuli applied from two different points at the same time. The evaluation starts from the widest gap (15 mm) and progresses to the narrowest gap (0 mm). The lowest distance range that the individual feels is recorded.
Change from baseline at 8 weeks
Modified Ashworth Scale (MAS)
Time Frame: Change from baseline at 8 weeks
Modified Ashworth Scale (MAS) is a test that evaluates the increase in muscle tone resulting from increased resistance during passive movement of the extremity. It is a 6-level spasticity measurement method scored in the range of 0-4. The higher the score, the greater the spasticity.
Change from baseline at 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Gross Motor Function Classification System (GMFCS)
Time Frame: Before the start of treatment
The Gross Motor Function Classification System (GMFCS) determines the level most appropriate to an individual's limitations and skills in gross motor functions. This classification measures the individual's self-initiated movements based on displacement, sitting and mobility, regardless of the individual's motor disorder type. As a result of the findings, individuals are divided into 5 levels according to their motor function levels. Individuals at Level 1 have minimal motor limitations.
Before the start of treatment
The Manual Ability Classification System (MACS)
Time Frame: Before the start of treatment
The Manual Ability Classification System (MACS) classifies how individuals with CP use their hands when holding objects in their daily activities in five levels. The individual at level 1 can hold and use objects easily and successfully, while the individual at level 5 cannot hold and use objects and has extremely limited skills to perform even simple activities. When determining levels, the ability of individuals to hold objects by themselves and the need for assistance in performing manual activities in daily life are taken into account.
Before the start of treatment

Collaborators and Investigators

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

Sponsor

Ankara Yildirim Beyazıt University

Investigators

  • Principal Investigator: Sena ÇARIKCI, MSc, Ankara Yıldırım Beyazıt University Health Sciences Institute
  • Study Chair: Nezehat Özgül ÜNLÜER, PhD, Saglik Bilimleri Universitesi
  • Study Chair: Şükrü TORUN, MD, Anadolu University Health Sciences Institute

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)

March 1, 2023

Primary Completion (Estimated)

March 17, 2024

Study Completion (Estimated)

June 20, 2024

Study Registration Dates

First Submitted

January 6, 2024

First Submitted That Met QC Criteria

January 6, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 6, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AYBU-NOUNLER-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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