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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06209840
• Other study ID #: AYBU-NOUNLER-001
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: June 20, 2024

Study information

• Verified date: January 2024
• Source: Ankara Yildirim Beyazit University
• Contact: Sena ÇARIKCI, MSc
• Phone: 05054284172
• Email: senacrkc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 20, 2024
• Est. primary completion date: March 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegic Cerebral Palsy
• Music Therapy
• Paralysis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Sena ÇARIKCI	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Gross Motor Function Classification System (GMFCS)	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
Other	The Manual Ability Classification System (MACS)	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
Primary	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
Primary	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
Primary	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
Primary	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	Semmes Weinstein Monofilament Test (SWMT)	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
Secondary	Two-Point Discrimination	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
Secondary	Modified Ashworth Scale (MAS)	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