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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05309096
Other study ID # 2022/141
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date November 1, 2023

Study information

Verified date November 2023
Source Afyonkarahisar Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Adapting the environment in which a child with Cerebral Palsy lives or adapting himself according to the environment facilitates independence in daily life activities. There is a need for practical performance tests to evaluate the gait adaptation of children with cerebral palsy in the clinic. However, no study has been found to evaluate gait adaptation in children with cerebral palsy. Therefore, the aim of the study is to evaluate the validity and reliability of the WALK test, which was previously developed for children with special learning disabilities, in individuals with cerebral palsy.


Description:

According to the International Classification of Functioning, Disability, and Health, physical, social, and behavioral environmental factors; can affect a child's disability, activity limitations, and participation. Adapting the environment in which a child with Cerebral Palsy lives or adapting himself according to the environment facilitates independence in daily life activities. There is a need for practical performance tests to evaluate the gait adaptation of children with cerebral palsy in the clinic. However, no study has been found to evaluate gait adaptation in children with cerebral palsy. Therefore, the aim of the study is to evaluate the validity and reliability of the WALK test, which was previously developed for children with special learning disabilities, in individuals with cerebral palsy. The study will be conducted by Afyonkarahisar University Faculty of Health Sciences.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date November 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria: - 6-18 years of age; - Diagnosed with Diparetic, Hemiparetic or Quadriparetic cerebral palsy; - GMFCS value being =3. - Communication Function Classification System (CFCS) for individuals with Cerebral Palsy =3. - Children with a Modified Ashworth Scale (MASH) = 3 for lower extremity muscles - Ability to follow verbal commands - Ability to recognize colors or numbers - Able to walk =10 meters independently with or without an assistive device (orthotics or walking aid) Exclusion Criteria: - Presence of serious hearing, vision or cognitive problems, - Nerve block injection or orthopedic surgery in the last 6 months (such as Botox injection or muscle lengthening surgery) - Joint contracture

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Emel Tasvuran Horata Afyonkarahisar

Sponsors (1)

Lead Sponsor Collaborator
Afyonkarahisar Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary WAL-K test The WAL-K test evaluates gait adaptation ability in children. A 10 meter long ladder is used for the test. The test is performed in two different conditions: taking only one step or taking two steps towards a target. The individual is video-recorded for the scoring of the test. Scoring records the total time (in seconds) and the total number of errors (tapping a stick, taking the wrong number of steps on a target, or missing a target) to complete the ladder back and forth. A combination score of time and errors is determined (0.5 s penalty is added to the elapsed time for each error). For the test, 1 trial and two formal tests are applied. The highest of the combination scores of the 2 formal tests is determined as the test result. 15 minutes
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