Cerebral PalsyNCT03640585
Effects of Music Therapy in Children With Cerebral Palsy
A study testing Music therapy in people with Cerebral Palsy, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Music therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Dec 2017to 23 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Music Therapy on Gross Motor Functions, Pain and Level of Functional Independence in Children With Cerebral Palsy
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.
Read the 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
- Being tested
- Music therapy
- Keywords
- Cerebral palsy, Music therapy, Gross motor function
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
Also called Control
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 minutes
Secondary outcomes (2)
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
Measured: 5 minutes
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
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start3 Dec 2017
- Primary completion2 May 2018
- Study completion23 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TOMRIS DUYMAZ, Istanbul Bilgi University
- Investigators
- TOMRIS DUYMAZ, Principal investigator, Istanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640585
- Sponsor's protocol ID
- IBU2015
- Status last verified
- Sep 2018
- First submitted
- 18 Aug 2018
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Music Therapy on Gross Motor Functions, Pain and Level of Functional Independence in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03640585
- Acronym / sponsor ID
- IBU2015
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Music therapy, Gross motor function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Study start
- 3 Dec 2017 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 23 Sep 2018 (estimated)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Music therapy | Experimental | Other: Music therapyChildren 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. |
| Control | Placebo comparator | Other: Music therapyOnly 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. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Acute and chronic infectious diseases
- Coagulation diseases
- Progressive cerebral diseases such as neoplasms
- Inherited diseases such as trisomy 21 syndrome
- Hearing loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapyAlso: ControlOnly 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. | Other | Control, Music therapy |
Primary outcome
Gross Motor Function Measurement
Time frame: 15 minutes
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
2 secondary outcomes
Functional independence measurement (WeeFIM)
Time frame: 5 minutes
Pain of extremities
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TOMRIS DUYMAZ principal investigator
Istanbul Bilgi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy in people with Cerebral Palsy, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Measurement (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.