Effects of Music Therapy in Children With Cerebral Palsy

NCT ID: NCT03640585

Last Updated: 2018-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-03
• Study Completion Date: 2018-09-23

Brief Summary

Purpose:To observe the effects of music therapy on gross motor functions, pain and functional independence measurement in children with cerebral palsy(CP).

Methods:Forty children with CP between 5-11years of age,were randomly divided into a music therapy(MT)+Neurodevelopmental techniques(NDT)group and only NDT group.Children listened to Classical music disc for 45 minutes.Children treated by NDT while listening to this music.Children were evaluated with Gross Motor Function Measurement(GMFM-88),WeeFIM for functional independence measurement,Wong-Baker faces pain rating scale (FACES) for pain intensity before,at the end of treatment and after 3 months of treatment.The treatments were given 3 times in every week,and totally 15 treatments were applied for 5 weeks.

Detailed Description

Participants Forty children with spastic CP between the ages of 5 and 11 years were enrolled in this study. Children were classified according to the Gross Motor Function Classification System. The patients were randomized and divided into 2 groups of 20 people. A randomized list is prepared in a computer environment by a statistician for randomization. In this list, the odd numbers for the control group and the MT group were given double numbers. The group identification is printed on sequentially numbered cards placed in sealed envelopes. After enrollment, the numbered envelope was opened by the patient and the blind investigator. The researcher started the session by placing the proper disc CD player before the beginning of the work. Children from 5 to 11 years of age, who had a spastic type CP diagnosis and were able to understand the commands as co-operative, with no hearing problems between GMFCS levels I and III were included in the study. Acute and chronic infectious diseases, coagulation diseases, progressive cerebral diseases such as neoplasms, inherited diseases such as trisomy 21 syndrome, hearing loss, surgery from the upper and lower extremity in the last 1 year, psychiatric problems, weak cooperatives were excluded from the study.

Study design Neurodevelopmental therapy was applied in the first group music accompaniment and only the neurodevelopmental therapy was applied in the second group without music. A total of 15 treatments were administered for 5 weeks, 3 sessions per week for all patients. The sessions were 45 minutes. Classical music is preferred as a musical style. The exercises performed in the musical accompaniment are made according to the rhythms in the music. The treatment schedule is planned so that the commands given to the illness and the movements required to be removed are made in the presence of rhythms. The age and body mass index (BMI) of all patients were recorded. Children were evaluated with Gross Motor Function Measurement (GMFM-88), WeeFIM for functional independence measurement, Wong-Baker faces pain rating scale (FACES) for pain intensity before, at the end of treatment and after 3 months of treatment. Outcome measures are described in more detail below. According to the power analysis results, when the number of enough participants was reached, the study was stopped. Ethics committee approval for the study was obtained from the Istanbul Science University Ethics Committee for Clinical Researches.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Music therapy

Children listened to Classical music disc for 45 minutes.Children treated by neurodevelopmental therapy while listening to this music.A total of 15 treatments were administered for 5 weeks, 3 sessions per week for all patients.

Group Type: EXPERIMENTAL

Music therapy

Intervention Type: OTHER

Only the neurodevelopmental therapy was applied in the second group without music. A total of 15 treatments were administered for 5 weeks, 3 sessions per week for all patients. The sessions were 45 minutes.

Control

Only the neurodevelopmental therapy was applied in the control group without music. A total of 15 treatments were administered for 5 weeks, 3 sessions per week for all patients. The sessions were 45 minutes.

Group Type: PLACEBO_COMPARATOR

Music therapy

Intervention Type: OTHER

Only the neurodevelopmental therapy was applied in the second group without music. A total of 15 treatments were administered for 5 weeks, 3 sessions per week for all patients. The sessions were 45 minutes.

Interventions

Music therapy

Only the neurodevelopmental therapy was applied in the second group without music. A total of 15 treatments were administered for 5 weeks, 3 sessions per week for all patients. The sessions were 45 minutes.

Intervention Type: OTHER

Other Intervention Names

Control

Eligibility Criteria

Inclusion Criteria

• Children from 5 to 11 years of age
• Who had a spastic type CP diagnosis
• able to understand the commands as co-operative
• no hearing problems
• between GMFCS levels I and III

Exclusion Criteria

• Acute and chronic infectious diseases
• Coagulation diseases
• Progressive cerebral diseases such as neoplasms
• Inherited diseases such as trisomy 21 syndrome
• Hearing loss
• Surgery from the upper and lower extremity in the last 1 year
• Psychiatric problems
• Weak cooperatives

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Bilgi University

OTHER

Sponsor Role: lead

Responsible Party

TOMRIS DUYMAZ

Asst. Prof. Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

TOMRIS DUYMAZ

Role: PRINCIPAL_INVESTIGATOR

Istanbul Bilgi University

Locations

Tomris Duymaz

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IBU2015

Identifier Type: -

Identifier Source: org_study_id