Effects of Music Therapy in Children With Cerebral Palsy

NCT03640585 | Unknown DMC

• 1 other identifier: IBU2015
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Cerebral palsy; Music therapy; Gross motor function

Outcome Measures

Primary Outcomes (1)

• 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

  15 minutes

Secondary Outcomes (2)

• Functional independence measurement (WeeFIM)

  5 minutes

• Pain of extremities

  1 minute

Study Arms (2)

Music therapy

EXPERIMENTAL

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.

Other: Music therapy

Control

PLACEBO COMPARATOR

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.

Other: Music therapy

Interventions

Music therapy 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.

Also known as: Control

Control; Music therapy

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Bilgi University: lead

Study Sites (1)

Tomris Duymaz

Istanbul, 34440, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• TOMRIS DUYMAZ

  Istanbul Bilgi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Ph.D.

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2018
• First Posted: August 21, 2018
• Study Start: December 3, 2017
• Primary Completion: May 2, 2018
• Study Completion: September 23, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

TU (1)