- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06378723
The Relationship Between Upper Extremity Functionality, Trunk Control and Balance in Children With Cerebral Palsy
Investigation of the Relationship Between Functionality, Trunk Control and Balance in Children With Cerebral Palsy
Study Overview
Status
Intervention / Treatment
Detailed Description
23 children with Cerebral Palsy and 30 healthy children will be included in the study, and the families of all children participating in the study will sign an informed consent form.After signing the consent form from the families of the children included in the study, their demographic information will be recorded and their Gross Motor Function Classification System levels will be determined.
Children's upper extremity functionality will be evaluated with the Quality of Upper Extremity Skills Test. To determine their functional balance, the Single-Leg Stance Test and the Four Step Square Test are measured. Additionally, balances will be determined by the Trunk Control Measurement Scale. Evaluations are made using tables and chairs. Evaluations take approximately 60 minutes, depending on the condition of the children, and all evaluations will be made one-on-one by the physiotherapist. In the study where power analysis was performed, 50 child evaluations were deemed appropriate. Statistical Package for the Social Sciences package program is used to analyze the data. Whether the data complies with normal distribution will be evaluated using the Shapiro Wilk Test and histogram graphs. Descriptive statistics are given as mean, standard deviation, median, number and percentage. Numerical data between groups are compared using Student's t test and Mann Whitney U test. Categorical data will be compared using the Chi Square test. Spearman's correlation test was used for correlation analysis, p value <0.05 will be considered statistically significant.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Famagusta, Cyprus, 99628
- Eastern Mediterranean University
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Çukurova
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Adana, Çukurova, Turkey (Türkiye), 01170
- Yeni Sihirli Eller Özel Eğitim ve Rehabilitasyon Merkezi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Between the ages of 8-18,
- Gross Motor Function Classification System level 1-2,
- Do not have severe visual or hearing impairment,
- Does not have any cooperation problems that would hinder communication,
- Children who have had Botulinum Toxin-A injection
Exclusion Criteria:
- Those with GMFC level 3-4-5,
- Children who had surgery within the last six months were not included in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Healthy Children
Healthy children between the ages of 8 and 18 will be included in the study.
Children with hearing and vision loss will be excluded from the study in order not to affect balance disorders.
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With the scales and tests the children trunk control, quality of upper extremity skills, single leg stance duration will be measured
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Cerebral Palsy Children
Cerebral Palsy children between the ages of 8 and 18 will be included in the study.
Children with hearing and vision loss will be excluded from the study in order not to affect balance disorders.
In order to standardize their mobility, those with Gross Motor Function Classification levels 1 and 2 will be included in the study.
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With the scales and tests the children trunk control, quality of upper extremity skills, single leg stance duration will be measured
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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trunk control
Time Frame: one month
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All the children will be measured with the Trunk Control Measurement Scale.
This test includes 15 items that measure static and dynamic sitting balance, two components of trunk control during functional activities.
All items are scored on 2, 3 or 4 points and are administered bilaterally.
The total score is between 0-58.
A high score indicates good performance.
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one month
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upper extremity functionality
Time Frame: one month
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All the children will be measured with the Quality of upper extremity skills test.
This test evaluates the quality of upper extremity movements; It evaluates in 4 different areas: independent movements, grasping, weight bearing and protective extension.
In protective extension, falling to the front, back and side using the arms is evaluated.
A "yes" or "no" score is given depending on the completion of each action or task.
Scores in these four areas are added together for a total score.
Additionally, hand function, spasticity and cooperation are also evaluated.
In hand function evaluation, 0 to 10 points are marked for the right hand, left hand and bilaterally.
In cooperation, children's cooperation statuses are marked as "not cooperative", "partially cooperative" and "fully cooperative".
During the evaluation, the child is not allowed to use any devices for the upper extremity.
Both the child's right and left upper extremities are scored separately.
Total score is between 0 and 100.
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one month
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balance
Time Frame: one month
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all the children will be measured with the Four Step Square Test and Single leg Stance test.
It is desirable to maintain this posture for as long as possible during the test.
The test and duration begin with the foot being lifted off the ground.
The test is repeated twice and the best time measured is noted in seconds (for single leg stance).
The test begins with one foot of the individual touching the ground in the 2nd square and ends with the last foot touching the ground in the 1st square.
The test is repeated twice for each individual and the test score completed in the shortest time is recorded in seconds (four step square test).
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one month
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Weight and Height
Time Frame: one month
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Weight and height will be combined to report BMI in kg/m2
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one month
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Emine Tuzun, Prof, Eastern Mediterranean University
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
- 2024/01/24
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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