Cerebral PalsyNCT03778398
Music Therapy In Adolescents With Cerebral Palsy
A study testing Neurologic music therapy in people with Cerebral Palsy, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
Purpose of the study; To improve the upper extremity motor functions of patients with adolescent cerebral palsy, Prevent treatment interruptions as age progresses, Increase the hand functions of children with cerebral palsy and to increase their living standards. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Neurologic music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2018to 20 Mar 2020
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being 11-18 years old
- To be diagnosed with cerebral palsy
- Not have been previously trained piano
- To have enough cognitive function to perform commands
- Accepted to participate in the study
Who cannot join
- Having cognitive disorder
- Advanced visual impairment, visual field defect
- To be previously trained for piano
- Another disease preventing upper extremity movements
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department
Istanbul, 34732
Bilinç Doğruöz Karatekin, +905368308709, bilincdogruoz@hotmail.com
Bilinç Doğruöz Karatekin, MD
About this study
Official title: The Effect Of Music Therapy On Upper Extremity Functions In Adolescents With Cerebral Palsy
Purpose of the study;
- To improve the upper extremity motor functions of patients with adolescent cerebral palsy,
- Prevent treatment interruptions as age progresses,
- Increase the hand functions of children with cerebral palsy and to increase their living standards.
Hand functions will be assessed with MACS (Manual Ability Classification System), hand dynamometer, box-block test, 9 hole peg test, pressing velocity measured with Cubase MIDI (musical instrument data interface) program. Patients will receive 2 days of 40 minutes per week, total 3 months of customized piano training. Each session will be started with finger warming exercises, then with the right hand, left handed and with both hands, a simple pentatonic array will be played. In the following lessons, notes will be marked with colors and simple songs will be taught. At the end of 3 months, the tests will be repeated.
Read the detailed description
Cerebral palsy is the development, movement and posture disorder that causes the limitation of activity which is thought to be caused by non-progressive disorders in the fetal or infant brain. Intensive rehabilitation program begins in early childhood; However, adults with cerebral palsy are less likely to receive rehabilitative interventions. There is a great need for effective upper extremity rehabilitation studies that motivate the patient in CP (cerebral palsy) rehabilitation after childhood. Therapeutic Instrumental Music Performance (TIMP) is one of the three techniques of neurological music therapy techniques for motor rehabilitation. This technique uses instruments to strengthen functional motor patterns. There are very few studies on TIMP in individuals with cerebral palsy and these studies have not been performed on patients with adolescent cerebral palsy.
Purpose of the study;
- To improve the upper extremity motor functions of patients with adolescent cerebral palsy,
- Prevent treatment interruptions as age progresses,
- Increase the hand functions of children with cerebral palsy and to increase their living standards.
Inclusion Criteria:
- Being 11-18 years old
- To be diagnosed with cerebral palsy
- Not have been previously trained piano
- To have enough cognitive function to perform commands
- Accepted to participate in the study
Criteria for not being included in research:
- Having cognitive disorder
- Advanced visual impairment, visual field defect
- To be previously trained for piano
- Another disease preventing upper extremity movements
Hand functions will be assessed with MACS (Manual Ability Classification System), hand dynamometer, box-block test, 9 hole peg test, pressing velocity measured with Cubase MIDI (musical instrument data interface) program. Patients will receive 2 days of 40 minutes per week, total 3 months of customized piano training. Each session will be started with finger warming exercises, then with the right hand, left handed and with both hands, a simple pentatonic array will be played. In the following lessons, notes will be marked with colors and simple songs will be taught. At the end of 3 months, the tests will be repeated.
- Conditions
- Cerebral Palsy
- Being tested
- Neurologic music therapy
- Keywords
- music therapy, cerebral palsy, piano training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurologic music therapyOther
Customized piano training
| Study group | Role | What they receive |
|---|---|---|
| Neurologic music therapy | Experimental | Patients will receive 2 days of 40 minutes per week, total 3 months of customized piano training. Each session will be started with finger warming exercises, then with the right hand, left handed and with both hands, a simple pentatonic array will be played. In the following lessons, notes will be marked with colors and simple songs will be taught. Receives: Other: Neurologic music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved hand function
Improvement on MACS (Manual Ability Classification System)
Measured: 3 months
Improved hand strength
Improvement on hand dynamometer and pressing velocities measured by Cubase MIDI (musical instrument data interface) program
Measured: 3 months
Improved fine motor skills
Improvement on box-block test
Measured: 3 months
Improved fine motor skills
Improvement on 9 hole peg test
Measured: 3 months
Secondary outcomes (1)
Improved hand coordination
observational, development of the ability to play the piano with two hands
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start20 Jun 2018
- Primary completion1 Feb 2020 (estimated)
- Study completion20 Mar 2020 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778398
- Sponsor's protocol ID
- IMU FTR
- Status last verified
- Dec 2018
- First submitted
- 2 Dec 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Music Therapy On Upper Extremity Functions In Adolescents With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03778398
- Acronym / sponsor ID
- IMU FTR
- Conditions
- Cerebral Palsy
- Keywords
- music therapy, cerebral palsy, piano training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 20 Mar 2020 (estimated)
- First posted
- 19 Dec 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 of the study;
- To improve the upper extremity motor functions of patients with adolescent cerebral palsy,
- Prevent treatment interruptions as age progresses,
- Increase the hand functions of children with cerebral palsy and to increase their living standards.
Hand functions will be assessed with MACS (Manual Ability Classification System), hand dynamometer, box-block test, 9 hole peg test, pressing velocity measured with Cubase MIDI (musical instrument data interface) program. Patients will receive 2 days of 40 minutes per week, total 3 months of customized piano training. Each session will be started with finger warming exercises, then with the right hand, left handed and with both hands, a simple pentatonic array will be played. In the following lessons, notes will be marked with colors and simple songs will be taught. At the end of 3 months, the tests will be repeated.
Detailed description
Cerebral palsy is the development, movement and posture disorder that causes the limitation of activity which is thought to be caused by non-progressive disorders in the fetal or infant brain. Intensive rehabilitation program begins in early childhood; However, adults with cerebral palsy are less likely to receive rehabilitative interventions. There is a great need for effective upper extremity rehabilitation studies that motivate the patient in CP (cerebral palsy) rehabilitation after childhood. Therapeutic Instrumental Music Performance (TIMP) is one of the three techniques of neurological music therapy techniques for motor rehabilitation. This technique uses instruments to strengthen functional motor patterns. There are very few studies on TIMP in individuals with cerebral palsy and these studies have not been performed on patients with adolescent cerebral palsy.
Purpose of the study;
- To improve the upper extremity motor functions of patients with adolescent cerebral palsy,
- Prevent treatment interruptions as age progresses,
- Increase the hand functions of children with cerebral palsy and to increase their living standards.
Inclusion Criteria:
- Being 11-18 years old
- To be diagnosed with cerebral palsy
- Not have been previously trained piano
- To have enough cognitive function to perform commands
- Accepted to participate in the study
Criteria for not being included in research:
- Having cognitive disorder
- Advanced visual impairment, visual field defect
- To be previously trained for piano
- Another disease preventing upper extremity movements
Hand functions will be assessed with MACS (Manual Ability Classification System), hand dynamometer, box-block test, 9 hole peg test, pressing velocity measured with Cubase MIDI (musical instrument data interface) program. Patients will receive 2 days of 40 minutes per week, total 3 months of customized piano training. Each session will be started with finger warming exercises, then with the right hand, left handed and with both hands, a simple pentatonic array will be played. In the following lessons, notes will be marked with colors and simple songs will be taught. At the end of 3 months, the tests will be repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurologic music therapy | Experimental | Other: Neurologic music therapyPatients will receive 2 days of 40 minutes per week, total 3 months of customized piano training. Each session will be started with finger warming exercises, then with the right hand, left handed and with both hands, a simple pentatonic array will be played. In the following lessons, notes will be marked with colors and simple songs will be taught. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Being 11-18 years old
- To be diagnosed with cerebral palsy
- Not have been previously trained piano
- To have enough cognitive function to perform commands
- Accepted to participate in the study
Key exclusion criteria (4 listed)
- Having cognitive disorder
- Advanced visual impairment, visual field defect
- To be previously trained for piano
- Another disease preventing upper extremity movements
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 |
|---|---|---|
| Neurologic music therapyCustomized piano training | Other | Neurologic music therapy |
Primary outcome
Improved hand function
Time frame: 3 months
Improvement on MACS (Manual Ability Classification System)
Improved hand strength
Time frame: 3 months
Improvement on hand dynamometer and pressing velocities measured by Cubase MIDI (musical instrument data interface) program
Improved fine motor skills
Time frame: 3 months
Improvement on box-block test
Improved fine motor skills
Time frame: 3 months
Improvement on 9 hole peg test
1 secondary outcome
Improved hand coordination
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurologic music therapy in people with Cerebral Palsy, run by Istanbul Medeniyet 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 4 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 19 Dec 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. 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?
Contact Bilinç Doğruöz Karatekin, MD (+905368308709, bilincdogruoz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved hand function (time frame: 3 months). The study lists 4 primary outcomes in all. 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 19 Dec 2018.