Cerebral PalsyNCT05640622
Turkish Validity and Reliability of Gait Outcomes Assessment List (GOAL)
An observational study of Cerebral Palsy, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Gait Outcomes Assessment List (GOAL)
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 1 Aug 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with Cerebral Palsy with GMFCS level 1,2, and 3
Who may be able to join
- Diagnosed with Cerebral Palsy
- Being able to read and write Turkish
Who cannot join
- Children who have had botox or orthopedic surgery in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Gait Outcomes Assessment List (GOAL)
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait Outcomes Assessment List (GOAL)Other
Gait Outcomes Assessment List (GOAL) is a scale developed to contribute to the determination of treatment goals. This questionnaire includes the priorities, expectations, and goals of children with CP who can walk and reveals their walking characteristics.
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Outcomes Assessment List (GOAL)
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).
Measured: 2 weeks
Secondary outcomes (2)
Functional Mobility Scale (FMS)
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.
Measured: 2 weeks
Gillette Functional Assessment Questionnaire (FAQ)
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'.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start15 Nov 2022
- Primary completion15 May 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umut Apaydin, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640622
- Sponsor's protocol ID
- E-77082166-604.01.02-487509
- Status last verified
- Aug 2023
- First submitted
- 28 Nov 2022
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29573409Bonfert 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.
PubMed 34933378
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Version of the Gait Outcomes Assessment List (GOAL) for Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05640622
- Acronym / sponsor ID
- E-77082166-604.01.02-487509
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 7 Dec 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with Cerebral Palsy with GMFCS level 1,2, and 3
Key inclusion criteria (2 listed)
- Diagnosed with Cerebral Palsy
- Being able to read and write Turkish
Key exclusion criteria (1 listed)
- Children who have had botox or orthopedic surgery in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait Outcomes Assessment List (GOAL)Gait Outcomes Assessment List (GOAL) is a scale developed to contribute to the determination of treatment goals. This questionnaire includes the priorities, expectations, and goals of children with CP who can walk and reveals their walking characteristics. | Other | – |
Primary outcome
Gait Outcomes Assessment List (GOAL)
Time frame: 2 weeks
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).
2 secondary outcomes
Functional Mobility Scale (FMS)
Time frame: 2 weeks
Gillette Functional Assessment Questionnaire (FAQ)
Time frame: 2 weeks
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 29 Dec 2023.
- Results publication: PubMed 29573409Thomason 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.
- Results publication: PubMed 34933378Bonfert 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Gazi 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 2 inclusion and 1 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 29 Dec 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?
Gait Outcomes Assessment List (GOAL) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05640622, which also lists 2 linked publications.
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 29 Dec 2023.