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

NCT06209840 | Unknown

• 1 other identifier: AYBU-NOUNLER-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy; Hemiplegic Cerebral Palsy; Music Therapy

Keywords

Cerebral Palsy; Music Therapy; Upper Extremity; Quality of Life

Outcome Measures

Primary Outcomes (4)

• Children's Hand-Use Experience Questionnaire (CHEQ)

  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

  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)

  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

  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 Outcomes (3)

• Semmes Weinstein Monofilament Test (SWMT)

  Change from baseline at 8 weeks

• Two-Point Discrimination

  Change from baseline at 8 weeks

• Modified Ashworth Scale (MAS)

  Change from baseline at 8 weeks

Other Outcomes (2)

• The Gross Motor Function Classification System (GMFCS)

  Before the start of treatment

• The Manual Ability Classification System (MACS)

  Before the start of treatment

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Classical physiotherapy program will be applied for gross motor functions and upper extremity functions.

Other: Control Group

Study (Music) Group

EXPERIMENTAL

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

Interventions

Control Group OTHER

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.

Also known as: Classical Physiotherapy

Control Group

Study (Music) Group OTHER

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.

Also known as: Music Therapy

Study (Music) Group

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Sena ÇARIKCI

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Control Groups; Population Groups; Music Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Demography; Population Characteristics; Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sena ÇARIKCI, MSc

  Ankara Yıldırım Beyazıt University Health Sciences Institute

  PRINCIPAL INVESTIGATOR

• Nezehat Özgül ÜNLÜER, PhD

  Saglik Bilimleri Universitesi

  STUDY CHAIR

• Şükrü TORUN, MD

  Anadolu University Health Sciences Institute

  STUDY CHAIR

Central Study Contacts

Sena ÇARIKCI, MSc

CONTACT

05054284172; senacrkc@gmail.com

Nezehat Özgül ÜNLÜER, PhD

CONTACT

05053009510; nunluer80@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: January 18, 2024
• Study Start: March 1, 2023
• Primary Completion: March 17, 2024
• Study Completion: June 20, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)