Cerebral PalsyNCT05309096
Validity and Reliability of the WAL-K Test
An observational study of Cerebral Palsy and Gait Disorders in Children, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Gait Disorders in Children
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Validity and Reliability of the Walking Adaptability Ladder Test (WAL-K) for Children in Children With Cerebral Palsy
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.
Read the detailed 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.
- Conditions
- Cerebral Palsy, Gait Disorders in Children
- Keywords
- cerebral palsy, gait
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Apr 2022
- Primary completion1 Jun 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Taşvuran Horata, Afyonkarahisar Health Sciences University
- Investigators
- EMEL TAŞVURAN HORATA, PhD, Principal investigator, AFSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309096
- Sponsor's protocol ID
- 2022/141
- Status last verified
- Nov 2023
- First submitted
- 25 Mar 2022
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Validity and Reliability of the Walking Adaptability Ladder Test (WAL-K) for Children in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05309096
- Acronym / sponsor ID
- 2022/141
- Conditions
- Cerebral Palsy, Gait Disorders in Children
- Keywords
- cerebral palsy, gait
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
WAL-K test
Time frame: 15 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EMEL TAŞVURAN HORATA, PhD principal investigator
AFSU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Gait Disorders in Children, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WAL-K test (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023; AzTrials last refreshed its copy on 30 Oct 2026.