Cerebral PalsyNCT06209840
The Effect of Music Therapy on Upper Extremity Functions and Quality Of Life in Individuals With Cerebral Palsy
A study testing Study (Music) Group in people with Cerebral Palsy and Hemiplegic Cerebral Palsy, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The main purpose of this study is to investigate the effect of music therapy on the upper extremity functions and quality of life of individuals with Cerebral Palsy (CP). The secondary aim is to investigate the effect of music therapy on the sensory functions of the upper extremity in individuals with CP. Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Cerebral Palsy, Hemiplegic Cerebral Palsy, Music Therapy
- What is being tested?
- Study (Music) Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 20 Jun 2024
- 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 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between the ages of 6-21
- With upper extremity dysfunction
- MACS score between 2-4,
- According to MAS, spasticity severity ranges from (1+) to (3),
- Individuals diagnosed with hemiparetic Cerebral Palsy who are at a cognitive level that can follow simple instructions during applications and evaluations will be included.
Who cannot join
- Having another neurological disorder
- Having undergone upper extremity orthopedic surgery or Botulinum Toxin A (BTX-A) application in the last 6 months,
- Individuals currently receiving another rehabilitation program in addition to classical physiotherapy for upper extremity rehabilitation will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sena ÇARIKCI
Ankara
Sena ÇARIKCI, 05054284172, senacrkc@gmail.com
Nezehat Özgül ÜNLÜER, 05053009510, nunluer80@yahoo.com
About this study
The main purpose of this study is to investigate the effect of music therapy on the upper extremity functions and quality of life of individuals with Cerebral Palsy (CP). The secondary aim is to investigate the effect of music therapy on the sensory functions of the upper extremity in individuals with CP. Adolescent individuals with hemiparetic CP will participate in this study, and the participants will experience music therapy, which is a scientific intervention approach. If music therapy has a positive effect on upper extremity functions, they will be more active in daily life and their quality of life will increase. In the light of these data to be presented, a contribution will be made to the evidence level of music therapy in the literature and to the content of SP upper extremity rehabilitation.
- Conditions
- Cerebral Palsy, Hemiplegic Cerebral Palsy, Music Therapy
- Being tested
- Control Group, Study (Music) Group
- Keywords
- Cerebral Palsy, Music Therapy, Upper Extremity, Quality of Life
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
Also called Classical Physiotherapy
The session is 50 minutes long and consists of 20 minutes of classical physiotherapy for gross motor functions and 30 minutes of classical physiotherapy for the upper extremity. A total of 16 sessions will be applied 2 days a week for 8 weeks.
Study (Music) GroupOther
Also called Music Therapy
The session is 50 minutes long and consists of 20 minutes of classical physiotherapy for gross motor functions and 30 minutes of music therapy for the upper extremity. A total of 16 sessions will be applied 2 days a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Classical physiotherapy program will be applied for gross motor functions and upper extremity functions. Receives: Other: Control Group |
| Study (Music) Group | Experimental | In addition to the classical physiotherapy program for gross motor functions, will be applied in the Neuro-Creative Music Therapy (NCMT) program for upper extremity. Receives: Other: Study (Music) Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Hand-Use Experience Questionnaire (CHEQ)
Children's Hand-Use Experience Questionnaire (CHEQ) is a scale that evaluates unilateral hand disorders in children due to various reasons (such as hemiparetic CP, brachial plexus or upper extremity developmental deficiency for any reason). CHEQ consists of 27 sub-items and evaluates quality aspects of movement in three different subscales, including the grasping efficiency of hand functions, the time required to perform the activity, and the feeling of discomfort caused by the affected hand during the performance of the activity.
Measured: Change from baseline at 8 weeks
Abilhand-Kids
Abilhand-Kids scale evaluates hand functions in children with CP. It measures the use of the upper extremity during children's daily activities in 21 items. There are 3 points in the scoring: 0: cannot be done, 1: difficult, 2: easy.
Measured: Change from baseline at 8 weeks
Selective Control of the Upper Extremity Scale (SCUES)
Selective Control of the Upper Extremity Scale (SCUES) is a measurement tool specifically designed for this area, developed to evaluate selective motor control of the upper extremity. It is a useful evaluation measure that is video-based and implemented in less than 15 minutes. The degree of selective motor control is determined for each joint as "normal selective motor control: 3 points, mildly reduced selective motor control: 2 points, moderately reduced selective motor control: 1 point, no selective motor control: 0 points".
Measured: Change from baseline at 8 weeks
Pediatric Quality of Life Inventory (PedsQL) 3.0 Cerebral Palsy Module
Pediatric Quality of Life Inventory (PedsQL) 3.0 Cerebral Palsy (CP) Module was developed to evaluate CP-specific quality of life areas of children with CP between the ages of 2-18. The scale questions the degree of problems experienced by individuals in the last month. The 35-item module consists of seven subscales: daily activities (9 items), school activities (4 items), movement and balance (5 items), pain and suffering (4 items), fatigue (4 items), eating activities (5 items), speech and communication (4 items). Subscale scores are calculated by dividing the total score of the answered items by the number of answered items. A higher mean score on a subscale of a field indicates that there are fewer problems in that field and the quality of life is higher.
Measured: Change from baseline at 8 weeks
Secondary outcomes (3)
Semmes Weinstein Monofilament Test (SWMT)
Semmes Weinstein Monofilament Test (SWMT) is a tactile test battery recommended to evaluate tactile sensation in individuals with CP. The SWMT battery has five different thicknesses of monofilament ranging from 2.83 to 6.65. The evaluation starts with the thinnest (2.83) filament and continues until the monofilament that the individual begins to feel.
Measured: Change from baseline at 8 weeks
Two-Point Discrimination
Two-Point Discrimination is used to evaluate tactile perception in individuals with CP. It evaluates the ability to perceive and distinguish tactile stimuli applied from two different points at the same time. The evaluation starts from the widest gap (15 mm) and progresses to the narrowest gap (0 mm). The lowest distance range that the individual feels is recorded.
Measured: Change from baseline at 8 weeks
Modified Ashworth Scale (MAS)
Modified Ashworth Scale (MAS) is a test that evaluates the increase in muscle tone resulting from increased resistance during passive movement of the extremity. It is a 6-level spasticity measurement method scored in the range of 0-4. The higher the score, the greater the spasticity.
Measured: Change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Mar 2023
- Primary completion17 Mar 2024 (estimated)
- Study completion20 Jun 2024 (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.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezehat Özgül, Saglik Bilimleri Universitesi
- Investigators
- Sena ÇARIKCI, MSc, Principal investigator, Ankara Yıldırım Beyazıt University Health Sciences InstituteNezehat Özgül ÜNLÜER, PhD, Study chair, Saglik Bilimleri UniversitesiŞükrü TORUN, MD, Study chair, Anadolu University Health Sciences Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209840
- Sponsor's protocol ID
- AYBU-NOUNLER-001
- Status last verified
- Jan 2024
- First submitted
- 6 Jan 2024
- Last updated
- 18 Jan 2024
- 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 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy on Upper Extremity Functions and Quality Of Life in Individuals With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06209840
- Acronym / sponsor ID
- AYBU-NOUNLER-001
- Conditions
- Cerebral Palsy, Hemiplegic Cerebral Palsy, Music Therapy
- Keywords
- Cerebral Palsy, Music Therapy, Upper Extremity, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 17 Mar 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 18 Jan 2024 (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.
The main purpose of this study is to investigate the effect of music therapy on the upper extremity functions and quality of life of individuals with Cerebral Palsy (CP). The secondary aim is to investigate the effect of music therapy on the sensory functions of the upper extremity in individuals with CP. Adolescent individuals with hemiparetic CP will participate in this study, and the participants will experience music therapy, which is a scientific intervention approach. If music therapy has a positive effect on upper extremity functions, they will be more active in daily life and their quality of life will increase. In the light of these data to be presented, a contribution will be made to the evidence level of music therapy in the literature and to the content of SP upper extremity rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Control GroupClassical physiotherapy program will be applied for gross motor functions and upper extremity functions. |
| Study (Music) Group | Experimental | Other: Study (Music) GroupIn addition to the classical physiotherapy program for gross motor functions, will be applied in the Neuro-Creative Music Therapy (NCMT) program for upper extremity. |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Between the ages of 6-21
- With upper extremity dysfunction
- MACS score between 2-4,
- According to MAS, spasticity severity ranges from (1+) to (3),
- Individuals diagnosed with hemiparetic Cerebral Palsy who are at a cognitive level that can follow simple instructions during applications and evaluations will be included.
Key exclusion criteria (3 listed)
- Having another neurological disorder
- Having undergone upper extremity orthopedic surgery or Botulinum Toxin A (BTX-A) application in the last 6 months,
- Individuals currently receiving another rehabilitation program in addition to classical physiotherapy for upper extremity rehabilitation will be excluded from the study.
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 |
|---|---|---|
| Control GroupAlso: Classical PhysiotherapyThe session is 50 minutes long and consists of 20 minutes of classical physiotherapy for gross motor functions and 30 minutes of classical physiotherapy for the upper extremity. A total of 16 sessions will be applied 2 days a week for 8 weeks. | Other | Control Group |
| Study (Music) GroupAlso: Music TherapyThe session is 50 minutes long and consists of 20 minutes of classical physiotherapy for gross motor functions and 30 minutes of music therapy for the upper extremity. A total of 16 sessions will be applied 2 days a week for 8 weeks. | Other | Study (Music) Group |
Primary outcome
Children's Hand-Use Experience Questionnaire (CHEQ)
Time frame: Change from baseline at 8 weeks
Children's Hand-Use Experience Questionnaire (CHEQ) is a scale that evaluates unilateral hand disorders in children due to various reasons (such as hemiparetic CP, brachial plexus or upper extremity developmental deficiency for any reason). CHEQ consists of 27 sub-items and evaluates quality aspects of movement in three different subscales, including the grasping efficiency of hand functions, the time required to perform the activity, and the feeling of discomfort caused by the affected hand during the performance of the activity.
Abilhand-Kids
Time frame: Change from baseline at 8 weeks
Abilhand-Kids scale evaluates hand functions in children with CP. It measures the use of the upper extremity during children's daily activities in 21 items. There are 3 points in the scoring: 0: cannot be done, 1: difficult, 2: easy.
Selective Control of the Upper Extremity Scale (SCUES)
Time frame: Change from baseline at 8 weeks
Selective Control of the Upper Extremity Scale (SCUES) is a measurement tool specifically designed for this area, developed to evaluate selective motor control of the upper extremity. It is a useful evaluation measure that is video-based and implemented in less than 15 minutes. The degree of selective motor control is determined for each joint as "normal selective motor control: 3 points, mildly reduced selective motor control: 2 points, moderately reduced selective motor control: 1 point, no selective motor control: 0 points".
Pediatric Quality of Life Inventory (PedsQL) 3.0 Cerebral Palsy Module
Time frame: Change from baseline at 8 weeks
Pediatric Quality of Life Inventory (PedsQL) 3.0 Cerebral Palsy (CP) Module was developed to evaluate CP-specific quality of life areas of children with CP between the ages of 2-18. The scale questions the degree of problems experienced by individuals in the last month. The 35-item module consists of seven subscales: daily activities (9 items), school activities (4 items), movement and balance (5 items), pain and suffering (4 items), fatigue (4 items), eating activities (5 items), speech and communication (4 items). Subscale scores are calculated by dividing the total score of the answered items by the number of answered items. A higher mean score on a subscale of a field indicates that there are fewer problems in that field and the quality of life is higher.
3 secondary outcomes
Semmes Weinstein Monofilament Test (SWMT)
Time frame: Change from baseline at 8 weeks
Two-Point Discrimination
Time frame: Change from baseline at 8 weeks
Modified Ashworth Scale (MAS)
Time frame: Change from baseline at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- 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.
Sena ÇARIKCI, MSc principal investigator
Ankara Yıldırım Beyazıt University Health Sciences Institute
Nezehat Özgül ÜNLÜER, PhD study chair
Saglik Bilimleri Universitesi
Şükrü TORUN, MD study chair
Anadolu University Health Sciences Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study (Music) Group in people with Cerebral Palsy and Hemiplegic Cerebral Palsy, run by Ankara Yildirim Beyazıt 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 3 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 18 Jan 2024. 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 Sena ÇARIKCI, MSc (05054284172, senacrkc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Hand-Use Experience Questionnaire (CHEQ) (time frame: Change from baseline at 8 weeks). 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 18 Jan 2024.