- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05621135
Validity and Reliability of the Sitting Assessment Scale in Cerebral Palsy
Study Overview
Status
Conditions
Detailed Description
Cerebral Palsy will be participate the study between the ages of 2 and 18 years. Children's classified with GMFCS and MACS.
Evaluation will be applied to the volunteer participants after the translation steps of the Sitting Evaluation Assessment are completed. The validity of the scale will be examined in terms of construct validity and content validity. All evaluations will be performed in the clinic with the specialist physiotherapist.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Demet GÖZAÇAN KARABULUT, PhD
- Phone Number: 2417 +90342 909 75 00
- Email: dg.karabulut@gmail.com
Study Locations
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Gaziantep, Turkey, 27010
- Gaziantep
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of Cerebral Palsy voluntary participation,
- Age between 2-18 years
Exclusion Criteria:
- Not voluntary to participate in the research,
- Botox in the last 6 months,
- Hip or spine surgeries in the last 6 months
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gross Motor Function Classification System (GMFCS)
Time Frame: At Baseline
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Assessing functional level and motor functions of children with CP.
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At Baseline
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Manuel ability classification system (MACS)
Time Frame: At Baseline
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This is a classification system based on the grasping and releasing objects in daily life, and how they use their hands while holding objects.
It is classify the hand skills of children with CP between the ages of 4-18.Children with CP are classified in five levels with MACS.
The higher level indicates worse hand function.
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At Baseline
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Gross Motor Function Measure-88
Time Frame: At Baseline
|
It is used to show gross motor functions and changes in these functions.
It consists of five main sections.
Each section can be used by calculating separately within itself.
The total score ranges from 0 to 100, with a high score indicating better function.
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At Baseline
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Trunk Control Measurement Scale
Time Frame: At Baseline
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This scale consists of two main parts as dynamic and static sitting balance.
The scale consists of 15 questions.
The scoring of the items is 0, 1, 2 or 3.
The total score ranges from 0 to 58, with a high score indicating better trunk control.
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At Baseline
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Sitting Assessment Scale
Time Frame: At Baseline and 2 weeks after the baseline
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The Sitting Assessment Scale is a standard observation tool designed for the assessment of sitting in children with CP.
The scale consists of five items evaluating head, trunk and foot control and arm and hand functions.The lowest score that can be obtained from the scale is 5 and the highest score is 20.
It can be stated that higher scores better functions.
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At Baseline and 2 weeks after the baseline
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Collaborators and Investigators
Investigators
- Study Director: Demet Gözaçan Karabulut, Gaziantep Islam Science and Technology 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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIBTU-FTR-DGK-2
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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