NCT05309096

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

March 25, 2022

Last Update Submit

November 13, 2023

Conditions

Keywords

cerebral palsygait

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants will consist of children diagnosed with diparetic, hemiparetic, quadriparetic cerebral palsy with a functional level of 1, 2, or 3 according to Gross Motor Function Classification System (GMFCS) in Afyonkarahisar Special Education and Rehabilitation Center in Afyonkarahisar province.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emel Taşvuran Horata

Afyonkarahisar, 03030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • EMEL TAŞVURAN HORATA, PhD

    AFSU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD; Assistant Professor

Study Record Dates

First Submitted

March 25, 2022

First Posted

April 4, 2022

Study Start

April 1, 2022

Primary Completion

June 1, 2023

Study Completion

November 1, 2023

Last Updated

November 15, 2023

Record last verified: 2023-11

Locations