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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05621135
Other study ID # GIBTU-FTR-DGK-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 15, 2022
Est. completion date September 5, 2023

Study information

Verified date February 2024
Source Gaziantep Islam Science and Technology University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Sitting Assessment Scale is a valid and reliable scale that evaluates sitting balance in Cerebral Palsy (CP). The validity and reliability study of the scale has been done, but it has not been adapted to Turkish language. The aim of this study is to adapt the Sitting Evaluation Scale, which evaluates sitting balance in Cerebral Palsy, into Turkish and to examine the validity and reliability of the Turkish version of the scale.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date September 5, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 2 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Gaziantep Gaziantep

Sponsors (1)

Lead Sponsor Collaborator
Gaziantep Islam Science and Technology University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gross Motor Function Classification System (GMFCS) Assessing functional level and motor functions of children with CP. At Baseline
Primary Manuel ability classification system (MACS) 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. At Baseline
Primary Gross Motor Function Measure-88 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. At Baseline
Primary Trunk Control Measurement Scale 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. At Baseline
Primary Sitting Assessment Scale 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. At Baseline and 2 weeks after the baseline
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