Cerebral PalsyNCT04884724
Adaptive Dance Exercise Program on Trunk Control, Balance and Functional Mobility in Cerebral Palsy
A study testing Adaptive Dance Exercise Program in people with Cerebral Palsy, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
Trial summary
The human body needs a system to control and coordinate its action plan in order to perform an effective action. This system works irregularly or inappropriately in people with Cerebral Palsy (CP). An alternative to controlling these disorders is automatic movement modulation such as dance. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Adaptive Dance Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 May 2021to 5 Oct 2021
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with Cerebral Palsy
- Volunteer
- Ages between of 6-18 years
- Gross Motor Function Classification System (GMFCS) Level 1 and Level 2
- To have cognitive skills to understand and apply adaptive dance exercises to be given.
Who cannot join
- Participants diagnosed with Cerebral Palsy having cognitive disorders
- Participants diagnosed with Cerebral Palsy having vision or hearing problems
- Participants diagnosed with Cerebral Palsy have a history of trauma such as botox or muscle relaxation operation and / or fracture at least 6 months before participating in the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul University-Cerrahpasa
Istanbul
Işıl Özel Eğitim ve Rehabilitasyon Merkezi
Istanbul
About this study
Official title: Effects of Adaptive Dance Exercise Program on Trunk Control, Balance and Functional Mobility in Children and Adolescents with Cerebral Palsy
The human body needs a system to control and coordinate its action plan in order to perform an effective action. This system works irregularly or inappropriately in people with Cerebral Palsy (CP). An alternative to controlling these disorders is automatic movement modulation such as dance. Dance, whose main purpose is to achieve a satisfying motor performance, increases motor learning with sensory, perceptual and emotional components. Although the effects of dance therapy on functionality, balance and participation in people with CP have been previously examined in the literature, it has been reported that the evidence is insufficient and more studies are needed. The aim of this study is to examine the effects of adaptive dance exercise program on trunk control, balance and functional mobility in children and adolescents with Cerebral Palsy.
- Conditions
- Cerebral Palsy
- Being tested
- Adaptive Dance Exercise Program
- Keywords
- Cerebral Palsy, Trunk Control, Mobility, Adaptive Dance, Balance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Dance Exercise ProgramOther
It is planned to include balance, stabilization, mobility, speed and rhythm activities for the exercises applied in Cerebral Palsy rehabilitation and based on the principles of motor learning, and to apply the dance steps and figures to be applied with visual and auditory stimuli.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Dance Exercise Group | Experimental | In addition to the routine physiotherapy programs received in the rehabilitation center for children and adolescents with cerebral palsy, an adaptive dance exercise program will be applied 2 days a week in the rehabilitation center for 5 weeks and online for 3 weeks in the presence of a physiotherapist. The duration of each session of the adaptive dance exercises to be applied is planned to be 45-60 minutes. It is planned that the adaptive dance exercises to be applied will be accompanied by the selected song.
Before and after the 8-week exercise program, the participants' trunk stabilization, balance, functional mobility and quality of life will be questioned with determined questionnaires and tests. Receives: Other: Adaptive Dance Exercise Program |
| Control Group | No intervention | Children and adolescents diagnosed with Cerebral Palsy will continue their routine physiotherapy and rehabilitation programs in the rehabilitation center. At the beginning of the study and after 8 weeks, the participants' trunk stabilization, balance, functional mobility and quality of life will be questioned with determined questionnaires and tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Control Measurement Scale (TCMS). Change is being assessed.
TCMS consists of static sitting balance, dynamic sitting control (Selective motor control and dynamic reaching) sections. The scale consists of 15 items in total and is divided into five, seven and three items. All items are evaluated bilaterally and scored on a 2, 3 or 4 point rank scale. TCMS total score is between 0-58 and the higher the score, the better the performance. Participants' trunk stabilization will be evaluated with TCMS.
Measured: Change from Baseline TCMS Score at 8 weeks
Pediatric Balance Scale (PBS). Change is being assessed.
The five-level consists of 14 elements such as sitting balance, standing balance, standing up from sitting, moving from standing to sitting, transfers, stepping, reaching, turning and jumping. Each item is scored between 0-4 points. High scores indicate better performance. Participants' balance will be evaluated with PBS.
Measured: Change from Baseline PBS Score at 8 weeks
Time Up and Go (TUG). Change is being assessed.
The participant sitting on the floor without arm support, hip and knee flexed at 90 degrees and feet on the ground are asked to stand up, walk 3 meters, turn around and sit on the chair. The test is applied 3 times, the time is recorded and the average of 3 trials is taken. Participants' functional mobility will be evaluated with TUG.
Measured: Change from Baseline TUG Score at 8 weeks
Secondary outcomes (1)
Pediatric Outcomes Data Collection Instrument (PODCI). Change is being assessed.
PODCI has 2 parent forms (child and adolescent) and adolescent forms consisting of the same questions. The test is a Likert-type scale and consists of 5 parts: Upper Extremity Functions-UEF, Physical Function and Sport-FFS, Transfer and Basic Mobility-TM, Pain-RA and Happiness / Satisfaction-MM, as well as Expectations-TB section where expectations from treatment are questioned. Each section is calculated between 0-100. Participants' quality of life will be evaluated with PODCI.
Measured: Change from Baseline PODCI Score 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 posted13 May 2021
- Study start20 May 2021
- Primary completion20 Sep 2021
- Study completion5 Oct 2021
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
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Asena Yekdaneh, Istanbul University - Cerrahpasa
- Investigators
- Ayşe Asena Yekdaneh, Pt.,MSc., Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884724
- Sponsor's protocol ID
- AAGulnergiz
- Status last verified
- Dec 2023
- First submitted
- 8 May 2021
- Last updated
- 14 Jan 2025
- 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 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adaptive Dance Exercise Program on Trunk Control, Balance and Functional Mobility in Children and Adolescents with Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04884724
- Acronym / sponsor ID
- AAGulnergiz
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Trunk Control, Mobility, Adaptive Dance, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 13 May 2021 (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 human body needs a system to control and coordinate its action plan in order to perform an effective action. This system works irregularly or inappropriately in people with Cerebral Palsy (CP). An alternative to controlling these disorders is automatic movement modulation such as dance. Dance, whose main purpose is to achieve a satisfying motor performance, increases motor learning with sensory, perceptual and emotional components. Although the effects of dance therapy on functionality, balance and participation in people with CP have been previously examined in the literature, it has been reported that the evidence is insufficient and more studies are needed. The aim of this study is to examine the effects of adaptive dance exercise program on trunk control, balance and functional mobility in children and adolescents with Cerebral Palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive Dance Exercise Group | Experimental | Other: Adaptive Dance Exercise ProgramIn addition to the routine physiotherapy programs received in the rehabilitation center for children and adolescents with cerebral palsy, an adaptive dance exercise program will be applied 2 days a week in the rehabilitation center for 5 weeks and online for 3 weeks in the presence of a physiotherapist. The duration of each session of the adaptive dance exercises to be applied is planned to be 45-60 minutes. It is planned that the adaptive dance exercises to be applied will be accompanied by the selected song. Before and after the 8-week exercise program, the participants' trunk stabilization, balance, functional mobility and quality of life will be questioned with determined questionnaires and tests. |
| Control Group | No intervention | –Children and adolescents diagnosed with Cerebral Palsy will continue their routine physiotherapy and rehabilitation programs in the rehabilitation center. At the beginning of the study and after 8 weeks, the participants' trunk stabilization, balance, functional mobility and quality of life will be questioned with determined questionnaires and tests. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosed with Cerebral Palsy
- Volunteer
- Ages between of 6-18 years
- Gross Motor Function Classification System (GMFCS) Level 1 and Level 2
- To have cognitive skills to understand and apply adaptive dance exercises to be given.
Key exclusion criteria (3 listed)
- Participants diagnosed with Cerebral Palsy having cognitive disorders
- Participants diagnosed with Cerebral Palsy having vision or hearing problems
- Participants diagnosed with Cerebral Palsy have a history of trauma such as botox or muscle relaxation operation and / or fracture at least 6 months before participating in 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 |
|---|---|---|
| Adaptive Dance Exercise ProgramIt is planned to include balance, stabilization, mobility, speed and rhythm activities for the exercises applied in Cerebral Palsy rehabilitation and based on the principles of motor learning, and to apply the dance steps and figures to be applied with visual and auditory stimuli. | Other | Adaptive Dance Exercise Group |
Primary outcome
Trunk Control Measurement Scale (TCMS). Change is being assessed.
Time frame: Change from Baseline TCMS Score at 8 weeks
TCMS consists of static sitting balance, dynamic sitting control (Selective motor control and dynamic reaching) sections. The scale consists of 15 items in total and is divided into five, seven and three items. All items are evaluated bilaterally and scored on a 2, 3 or 4 point rank scale. TCMS total score is between 0-58 and the higher the score, the better the performance. Participants' trunk stabilization will be evaluated with TCMS.
Pediatric Balance Scale (PBS). Change is being assessed.
Time frame: Change from Baseline PBS Score at 8 weeks
The five-level consists of 14 elements such as sitting balance, standing balance, standing up from sitting, moving from standing to sitting, transfers, stepping, reaching, turning and jumping. Each item is scored between 0-4 points. High scores indicate better performance. Participants' balance will be evaluated with PBS.
Time Up and Go (TUG). Change is being assessed.
Time frame: Change from Baseline TUG Score at 8 weeks
The participant sitting on the floor without arm support, hip and knee flexed at 90 degrees and feet on the ground are asked to stand up, walk 3 meters, turn around and sit on the chair. The test is applied 3 times, the time is recorded and the average of 3 trials is taken. Participants' functional mobility will be evaluated with TUG.
1 secondary outcome
Pediatric Outcomes Data Collection Instrument (PODCI). Change is being assessed.
Time frame: Change from Baseline PODCI Score at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- 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.
Ayşe Asena Yekdaneh, Pt.,MSc. principal investigator
Istanbul University - Cerrahpasa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Dance Exercise Program in people with Cerebral Palsy, run by Istanbul University - Cerrahpasa at 2 sites 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: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Trunk Control Measurement Scale (TCMS). Change is being assessed. (time frame: Change from Baseline TCMS Score at 8 weeks). The study lists 3 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 14 Jan 2025.