- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04884724
Adaptive Dance Exercise Program on Trunk Control, Balance and Functional Mobility in Cerebral Palsy
Effects of Adaptive Dance Exercise Program on Trunk Control, Balance and Functional Mobility in Children and Adolescents With Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Istanbul University-Cerrahpasa
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Istanbul, Turkey
- Işıl Özel Eğitim ve Rehabilitasyon Merkezi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Adaptive Dance Exercise Group
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. |
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.
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No Intervention: Control Group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trunk Control Measurement Scale (TCMS). Change is being assessed.
Time Frame: Change from Baseline TCMS Score at 8 weeks
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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.
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Change from Baseline TCMS Score at 8 weeks
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Pediatric Balance Scale (PBS). Change is being assessed.
Time Frame: Change from Baseline PBS Score at 8 weeks
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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.
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Change from Baseline PBS Score at 8 weeks
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Time Up and Go (TUG). Change is being assessed.
Time Frame: Change from Baseline TUG Score at 8 weeks
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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.
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Change from Baseline TUG Score at 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pediatric Outcomes Data Collection Instrument (PODCI). Change is being assessed.
Time Frame: Change from Baseline PODCI Score at 8 weeks
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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.
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Change from Baseline PODCI Score at 8 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Ayşe Asena Yekdaneh, Pt.,MSc., Istanbul University - Cerrahpasa (IUC)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAGulnergiz
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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