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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05184244
Other study ID # IKC444
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date November 1, 2021

Study information

Verified date December 2021
Source Izmir Katip Celebi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aimed to make the Turkish adaptation of ACTIVLIM-CP and to examine its psychometric properties. Eighty-nine individuals with CP, aged between 2-18 years were included in the study. PEDÄ°, ABILOCO-Kids, and ABILHAND-Kids scores and Wee-FIM questionnaires were used for validity analysis. Test re-test method was used for reliability.


Description:

Cerebral Palsy (CP) is a clinical picture with permanent disorders of the development of movement and posture whether assessing activity limitations matters. This study aimed to make the Turkish adaptation of ACTIVLIM-CP and to examine its psychometric properties. The internal consistency of the scale was evaluated using Cronbach's alpha value and the inter-measurement reliability using the intraclass correlation coefficient (ICC). In construct validity analysis; ACTIVLIM-CP score; was correlated with PEDÄ°, ABILOCO-Kids, and ABILHAND-Kids scores and Wee-FIM total scores. A known group comparison was made according to ambulation and epilepsy existence with the Principal Components Explanatory Factor Analysis.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date November 1, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers
Gender All
Age group 2 Years to 18 Years
Eligibility Inclusion Criteria: - children with CP who were diagnosed by a child neurologist - having physical therapy sessions at special education and rehabilitation center - age between 2 and 18 Exclusion Criteria: - whose parent was illiterate or doesn't speak Turkish - whose parent wasn't complete the questionnaires

Study Design


Intervention

Other:
Activity Limitation Assessment
The ACTIVLIM-CP scale evaluates the global activity performance and combined movements of the body.

Locations

Country Name City State
Turkey Ilknur Naz Gürsan Izmir

Sponsors (1)

Lead Sponsor Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Global Activity Performance assessment ACTIVLIM-CP: Caregiver rates the difficulty degree of 43 activities easy/difficult/impossible/unknown). Questionnaire scores between 0 and 86 points. A higher score shows better activity performance 15 minutes
Secondary Gunctional capabilities and limitations Gross Motor Function Classification System: It classifies the motor function of a child from level 1 (slightly affected) to level 5 (severely affected) 5 minutes
Secondary Functional independence measurement Functional Independence Measure for Children: The scale includes 18 measurement items and every item scores between 1 -7. A higher score shows more independence 15 minutes
Secondary Child's ability to walk assessment Abiloco-Kids: It consists of 10 questions for evaluating the walking performance from the viewpoint of the caregiver. Questionnaire scores between 0 and 20 points. A higher score shows better activity performance 10 minutes
Secondary child's manual ability assessment Abilhand-Kids: It consists of 21 questions to measure the manual ability from the viewpoint of the family. Questionnaire scores between 0 and 42 points. A higher score shows better activity performance. 15 minutes
Secondary Functional assessment Pediatric Evaluation of Disability Inventory (PEDI): It consists of three Functional Skills Scales, three Caregiver Assistance Scales, and three Modification Scales in the content areas of self-care, mobility, and social function. Functional Skills has 197 items and each item scores as 1(able) and 2(unable), Caregiver Assistance scores between 0(dependent) -5(independent) and Modifications assessing with frequencies . 20 minutes
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