search
Back to results

Effects of Music Therapy in Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Music therapy
Sponsored by
Istanbul Bilgi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral palsy, Music therapy, Gross motor function

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tomris Duymaz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Music therapy

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Gross Motor Function Measurement
The gross motor functions of children with CP have been evaluated with the Gross Motor Function Measurement (GMFM-88), which has been widely used in recent years. There are 5 main divisions. It consists of a total of 88 items consisting of 17 in the supine, prone position and turning section, 20 in the sitting section, 14 in the crawling-laptops section, 13 in the standing section and 24 in the walking-running-stair climbing section. Score 0- The movement can not start. 1- Actively initiates a certain amount of movement (<10%) 2- Completely completes the movement but can not finish (10% - 90%). 3- Completes the movement independently. Each section score is calculated within itself as a percentage, then the five percent score is summed, divided by 5, and the total percentile score is found

Secondary Outcome Measures

Functional independence measurement (WeeFIM)
It is a useful, short, comprehensive method of measuring functional, educational, and socially functional limitations of children with CP and other developmental disabilities. The WeeFIM includes 6 items in total, 18 items including self care, sphincter control, transfers, locomotion, communication, social and cognitive. In performing the functions of each item in these areas, the score is scored from 1 to 7, depending on whether or not they get help, whether they do it on time, or whether an auxiliary device is needed. When the task is done with help completely 1; 7 is considered to be totally independent, at the appropriate time and in a safe manner. 1-7 points are awarded depending on the amount of the help. Accordingly, scores of at least 18 (fully dependent) and 126 (fully independent) can be taken
Pain of extremities
FACES is a pain severity scale that scales from 0 to 10, which can be determined by the child's face expressions without the need for communication that will force them to express the pain they feel when they are 3 years old and older. 0 points means no pain at all, 10 points means severe pain at irresistible levels

Full Information

First Posted
August 18, 2018
Last Updated
September 6, 2018
Sponsor
Istanbul Bilgi University
search

1. Study Identification

Unique Protocol Identification Number
NCT03640585
Brief Title
Effects of Music Therapy in Children With Cerebral Palsy
Official Title
The Effects of Music Therapy on Gross Motor Functions, Pain and Level of Functional Independence in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 3, 2017 (Actual)
Primary Completion Date
May 2, 2018 (Actual)
Study Completion Date
September 23, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Bilgi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral palsy, Music therapy, Gross motor function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Music therapy
Other Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gross Motor Function Measurement
Description
The gross motor functions of children with CP have been evaluated with the Gross Motor Function Measurement (GMFM-88), which has been widely used in recent years. There are 5 main divisions. It consists of a total of 88 items consisting of 17 in the supine, prone position and turning section, 20 in the sitting section, 14 in the crawling-laptops section, 13 in the standing section and 24 in the walking-running-stair climbing section. Score 0- The movement can not start. 1- Actively initiates a certain amount of movement (<10%) 2- Completely completes the movement but can not finish (10% - 90%). 3- Completes the movement independently. Each section score is calculated within itself as a percentage, then the five percent score is summed, divided by 5, and the total percentile score is found
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Functional independence measurement (WeeFIM)
Description
It is a useful, short, comprehensive method of measuring functional, educational, and socially functional limitations of children with CP and other developmental disabilities. The WeeFIM includes 6 items in total, 18 items including self care, sphincter control, transfers, locomotion, communication, social and cognitive. In performing the functions of each item in these areas, the score is scored from 1 to 7, depending on whether or not they get help, whether they do it on time, or whether an auxiliary device is needed. When the task is done with help completely 1; 7 is considered to be totally independent, at the appropriate time and in a safe manner. 1-7 points are awarded depending on the amount of the help. Accordingly, scores of at least 18 (fully dependent) and 126 (fully independent) can be taken
Time Frame
5 minutes
Title
Pain of extremities
Description
FACES is a pain severity scale that scales from 0 to 10, which can be determined by the child's face expressions without the need for communication that will force them to express the pain they feel when they are 3 years old and older. 0 points means no pain at all, 10 points means severe pain at irresistible levels
Time Frame
1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TOMRIS DUYMAZ
Organizational Affiliation
Istanbul Bilgi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tomris Duymaz
City
Istanbul
ZIP/Postal Code
34440
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effects of Music Therapy in Children With Cerebral Palsy

We'll reach out to this number within 24 hrs