- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05640622
Turkish Validity and Reliability of Gait Outcomes Assessment List (GOAL)
December 28, 2023 updated by: Umut Apaydin, Gazi University
Reliability and Validity of the Turkish Version of the Gait Outcomes Assessment List (GOAL) for Children With Cerebral Palsy
The aim of this study is to investigate the reliability and validity of the Turkish Gait Outcomes Assessment List (GOAL) Questionnaire, in children with cerebral palsy (CP) with GMFCS level1, 2, and 3.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Most children with cerebral palsy (CP) can walk.
Musculoskeletal disorders of these children cause deterioration in gait functions.
Disruptions in gait limit children's participation.
To minimize these impairments, various interventions are usually applied to children with CP who can walk.
The ultimate goal of these interventions is to help these children achieve the best possible participation in activities of daily living.
In addition, goal determination by children and families in treatment planning is important in terms of treatment success.
The Gait Outcomes Assessment List (GOAL) is a scale developed to contribute to the determination of these goals.
This questionnaire includes the priorities, expectations, and goals of children with CP who can walk and reveals their walking characteristics.
The questionnaire is used in two languages, English and German, and there is no Turkish version of the questionnaire.
Therefore, the aim of this study is to create the Turkish version of the 'Gait Outcomes Assessment List (GOAL)' family and child questionnaires and to examine its validity and reliability.
Study Type
Observational
Enrollment (Actual)
81
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey
- Gazi University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Children with Cerebral Palsy with GMFCS level 1,2, and 3
Description
Inclusion Criteria:
- Diagnosed with Cerebral Palsy
- Being able to read and write Turkish
Exclusion Criteria:
- Children who have had botox or orthopedic surgery in the last 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait Outcomes Assessment List (GOAL)
Time Frame: 2 weeks
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The GOAL consists of 49 items grouped into seven domains: domain A, activities of daily living and independence; domain B, gait function and mobility; domain C, pain, discomfort, and fatigue; domain D, physical activities, sports, and recreation; domain E, gait pattern and appearance; domain F, use of braces and mobility aids; and domain G, body image and self-esteem.
Domains A, B, D, and E consist of 6-point Likert scales changing from extremely difficult to no problem at all.
Domain C consists of 5-point Likert scales changing from everyday to none of the time.
Domains F and G, consist of 5-point Likert scales changing from very unhappy to very happy.
Domain and total GOAL scores were calculated for each child and ranged from 0 (worst) to 100 (best).
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2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Mobility Scale (FMS)
Time Frame: 2 weeks
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The FMS is a performance measure, classifying mobility on the basis of the use of mobility devices across three distances, 5m, 50m, and 500m, which represent home, school, and community distances.
Assessment is by the clinician on the basis of questions asked of the parent or child.
The mobility of the child is scored from 1 to 6 for each distance, with 1 representing the use of a wheelchair and 6 representing independence on all surfaces.
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2 weeks
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Gillette Functional Assessment Questionnaire (FAQ)
Time Frame: 2 weeks
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The Gillette Functional Assessment Questionnaire (FAQ) is a self or proxy-report measure that includes a ten-level classification of ambulatory function (FAQ Walking Scale), and 22 functional locomotor activities rated on a five-level Likert difficulty scale (FAQ 22-item skill set).
The FAQ 22-item skill set includes common functional mobility activities that further characterize the individual's locomotor abilities.
The five-level Likert response scale used for the 22 skill items was 'easy', 'a little hard', 'very hard', 'can't do at all', and 'too young for activity'.
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2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Thomason P, Tan A, Donnan A, Rodda J, Graham HK, Narayanan U. The Gait Outcomes Assessment List (GOAL): validation of a new assessment of gait function for children with cerebral palsy. Dev Med Child Neurol. 2018 Jun;60(6):618-623. doi: 10.1111/dmcn.13722. Epub 2018 Mar 24.
- Bonfert MV, Jelesch E, Hartmann J, Koenig H, Warken B, Meuche A, Jung NH, Bernius P, Weinberger R, Sorg AL, von Kries R, Narayanan UG, Hoesl M, Berweck S, Schroeder AS. Test-Retest Reliability and Construct Validity of the German Translation of the Gait Outcome Assessment List (GOAL) Questionnaire for Children with Ambulatory Cerebral Palsy. Neuropediatrics. 2022 Apr;53(2):96-101. doi: 10.1055/s-0040-1722688. Epub 2021 Dec 21.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2022
Primary Completion (Actual)
May 15, 2023
Study Completion (Actual)
August 1, 2023
Study Registration Dates
First Submitted
November 28, 2022
First Submitted That Met QC Criteria
November 28, 2022
First Posted (Actual)
December 7, 2022
Study Record Updates
Last Update Posted (Actual)
December 29, 2023
Last Update Submitted That Met QC Criteria
December 28, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-77082166-604.01.02-487509
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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