Clinical trial NCT03640585: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
Music therapy
Gross motor function
Lead sponsor: Istanbul Bilgi University
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Gross Motor Function Measurement
timeFrame: 15 minutes
Secondary outcomes:
measure: Functional independence measurement (WeeFIM)
timeFrame: 5 minutes
measure: Pain of extremities
timeFrame: 1 minute
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Tomris Duymaz
Study officials:
affiliation: Istanbul Bilgi University
name: TOMRIS DUYMAZ
role: PRINCIPAL_INVESTIGATOR
References: