Rheumatologic DiseaseNCT05846672
Turkish Cultural Adaptation, Validity and Reliability of the "Gait Outcomes Assessment List"
An observational study of Rheumatologic Disease and Pediatric ALL, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The ultimate goal of treating children with lower extremity differences is to improve quality of life, optimize function, and maximize participation by addressing the physical, social, and psychological effects of lower extremity differences. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Rheumatologic Disease, Pediatric ALL, Children, Only
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2023to 30 Dec 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
- No healthy volunteers
- Child, Adult
Study population: Diagnosed with pediatric rheumatological disease aged 6-18 years, treated in the pediatric rheumatology clinic of Istanbul University Medical Faculty Hospital and who meet the inclusion criteria will be included in our study.
Who may be able to join
- Volunteer
- Diagnosed with chronic rheumatological disease
- 6-18 ages
- Have reading and writing skills
- Residing in Turkey
- To have the cognitive skills to understand and answer the questions in the questionnaires
Who cannot join
- Have had lower extremity surgery in the past 6 months
- Have had lower extremity surgery in the past 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Medical Faculty Hospital
Istanbul, 34093
About this study
Official title: Turkish Cultural Adaptation, Validity, and Reliability of the "Gait Outcomes Assessment List for Children With Lower-Limb Difference Parent Version/ Child Version" in Pediatric Rheumatologic Diseases
The ultimate goal of treating children with lower extremity differences is to improve quality of life, optimize function, and maximize participation by addressing the physical, social, and psychological effects of lower extremity differences. In the pediatric field, research has focused on the Body Functions and Structures area of the ICF framework, such as radiographic measurements of limb alignment and length, postoperative complications, and recovery time. Priority targets for children/parents are better captured in the Activity and Participation areas of the ICF framework.
Developed in Canada, the Gait Outcomes Assessment List (GOAL)was created to evaluate outcomes for gait-related interventions for children with cerebral palsy based on a wide range of children's and parents' goals. It was also developed for other childhood conditions associated with lower extremity disorders. The present study aimed to determine the Turkish cultural adaptation, validity, and reliability of the "Gait Outcomes Assessment List for Children With Lower-Limb Difference Parent Version/ Child Version" in Pediatric Rheumatologic Diseases.
Read the detailed description
The International Classification of Functioning, Disability, and Health (ICF) is a useful framework for assessing and categorizing lower extremity problems. The ultimate goal of treating children with lower extremity differences is to improve quality of life, optimize function, and maximize participation by addressing the physical, social, and psychological effects of lower extremity differences. Research on this topic in the pediatric field has focused on the Body Functions and Structures area of the ICF framework, such as radiographic measurements of limb alignment and length, postoperative complications, and recovery time. While this area is an important predictor of the technical success of an intervention, it cannot be assumed that these are priority targets for children/parents. It also does not correspond to the most important factor in quality of life outcomes. Priority targets are better captured in the Activity and Participation areas of the ICF framework.
Gait Outcomes Assessment List (GOAL) is a multidimensional, self-administered child and parent report developed using the Priority Framework as its conceptual framework.
Developed in Canada, the GOAL was created to evaluate outcomes for gait-related interventions for children with cerebral palsy based on a wide range of children's and parents' goals. It was also developed for other childhood conditions associated with lower extremity disorders. Lower extremity and walking functions change due to joint swelling, effusion, tenderness, and painful restriction in joint movement, which are common, especially in load-bearing joints in pediatric rheumatological diseases. These changes affect kinematic and kinetic parameters and cause functional limitations. Evaluation of functional limitations within the framework of ICF, especially within the scope of participation, forms the basis of "treat-to-target" conception.
The present study was designed to determine the Turkish cultural adaptation, validity, and reliability of the "Gait Outcomes Assessment List for Children With Lower-Limb Difference Parent Version/ Child Version" in Pediatric Rheumatologic Diseases. To evaluate the validity, Childhood Health Assessment Questionnaire (CHAQ), Six Minute Walk Test (6MWT), and 10 Stair Climb Test (10SCT) will be applied. The Turkish form of GOAL will be applied again after 7 days to evaluate reliability. All forms will be applied by a physiotherapist.
This study plans to include 200 children with chronic rheumatological disease. Factor analysis methods will be used in the analysis of the factor structure of the scale, and correlation analyses (Pearson and Spearman coefficients) will be used in the analysis of validity and test-retest reliability. Cronbach's alpha analysis will be used in the reliability analysis.
- Medical subject headings
- Collagen Diseases, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Outcomes Assessment List for Children with Lower-Limb Difference (GOAL-LD)
It was developed by Dermott et al. The original version of the parent- and child-reported GOAL questionnaire used in this study, consists of 44 items across seven domains: (A) Walking and getting around, (B) Pain/Discomfort/Fatigue, (C) Physical Activities, Games \& Recreation, (D) Gait Appearance, (E) Use of Braces \& Assistive Devices, and (F) Body Image \& Self-Esteem.
Measured: Change from baseline to 7 day
6 Minute Walk Test (6 MWT)
The 6-minute walk test is a well-tolerated, easy-to-apply and simple test that shows the submaximal level of functional capacity. This test measures the distance that participants can walk quickly on a hard and flat surface in 6 minutes. Participants rest in a chair near the starting position for at least 10 minutes before the start of the test. Before and after the test, heart rate, blood pressure, saturation are measured, and fatigue level is determined with the Modified Borg scale. Participants are told how to perform the test. At the end of the test, the distance walked by the participants in 6 minutes will be recorded in meters.
Measured: Baseline
10 Stair Climb Test (10SCT)
10 Stair Climb Test is a measure of ability to ascend and descend a flight of stairs. We will ask the patient to go walk as quickly as patients feel safe and comfortable to the top of the 10 stairs, and than turn around, and come back down. Physiotherapist will stop the clock when the patients second foot touches the landing. Seconds will recorded.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start30 May 2023
- Primary completion30 Oct 2023
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatologic DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Arman, Istanbul University - Cerrahpasa
- Investigators
- Nilay Arman, Assoc. Prof., Principal investigator, Istanbul University-Cerrahpaşa, Faculty of Health ScienceAsena Yekdaneh, Pt. MSc., Study chair, Fenerbahce UniversityAsya Albayrak, Pt. MSc., Study chair, Istanbul Kent UniversityNuray Aktay Ayaz, Prof. Dr., Study chair, Istanbul University Medical FacultyAyşenur Namlı, Pt. MSc., Study chair, Aydın UniversityFatma Gül Demirkan, MD, Study chair, Istanbul University Medical FacultyÖzlem Akgün, MD, Study chair, Istanbul University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846672
- Sponsor's protocol ID
- NAAAArman
- Status last verified
- Dec 2023
- First submitted
- 27 Apr 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Cultural Adaptation, Validity, and Reliability of the "Gait Outcomes Assessment List for Children With Lower-Limb Difference Parent Version/ Child Version" in Pediatric Rheumatologic Diseases
- ClinicalTrials.gov ID
- NCT05846672
- Acronym / sponsor ID
- NAAAArman
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 6 May 2023 (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 ultimate goal of treating children with lower extremity differences is to improve quality of life, optimize function, and maximize participation by addressing the physical, social, and psychological effects of lower extremity differences. In the pediatric field, research has focused on the Body Functions and Structures area of the ICF framework, such as radiographic measurements of limb alignment and length, postoperative complications, and recovery time. Priority targets for children/parents are better captured in the Activity and Participation areas of the ICF framework.
Developed in Canada, the Gait Outcomes Assessment List (GOAL)was created to evaluate outcomes for gait-related interventions for children with cerebral palsy based on a wide range of children's and parents' goals. It was also developed for other childhood conditions associated with lower extremity disorders. The present study aimed to determine the Turkish cultural adaptation, validity, and reliability of the "Gait Outcomes Assessment List for Children With Lower-Limb Difference Parent Version/ Child Version" in Pediatric Rheumatologic Diseases.
Detailed description
The International Classification of Functioning, Disability, and Health (ICF) is a useful framework for assessing and categorizing lower extremity problems. The ultimate goal of treating children with lower extremity differences is to improve quality of life, optimize function, and maximize participation by addressing the physical, social, and psychological effects of lower extremity differences. Research on this topic in the pediatric field has focused on the Body Functions and Structures area of the ICF framework, such as radiographic measurements of limb alignment and length, postoperative complications, and recovery time. While this area is an important predictor of the technical success of an intervention, it cannot be assumed that these are priority targets for children/parents. It also does not correspond to the most important factor in quality of life outcomes. Priority targets are better captured in the Activity and Participation areas of the ICF framework.
Gait Outcomes Assessment List (GOAL) is a multidimensional, self-administered child and parent report developed using the Priority Framework as its conceptual framework.
Developed in Canada, the GOAL was created to evaluate outcomes for gait-related interventions for children with cerebral palsy based on a wide range of children's and parents' goals. It was also developed for other childhood conditions associated with lower extremity disorders. Lower extremity and walking functions change due to joint swelling, effusion, tenderness, and painful restriction in joint movement, which are common, especially in load-bearing joints in pediatric rheumatological diseases. These changes affect kinematic and kinetic parameters and cause functional limitations. Evaluation of functional limitations within the framework of ICF, especially within the scope of participation, forms the basis of "treat-to-target" conception.
The present study was designed to determine the Turkish cultural adaptation, validity, and reliability of the "Gait Outcomes Assessment List for Children With Lower-Limb Difference Parent Version/ Child Version" in Pediatric Rheumatologic Diseases. To evaluate the validity, Childhood Health Assessment Questionnaire (CHAQ), Six Minute Walk Test (6MWT), and 10 Stair Climb Test (10SCT) will be applied. The Turkish form of GOAL will be applied again after 7 days to evaluate reliability. All forms will be applied by a physiotherapist.
This study plans to include 200 children with chronic rheumatological disease. Factor analysis methods will be used in the analysis of the factor structure of the scale, and correlation analyses (Pearson and Spearman coefficients) will be used in the analysis of validity and test-retest reliability. Cronbach's alpha analysis will be used in the reliability analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Diagnosed with pediatric rheumatological disease aged 6-18 years, treated in the pediatric rheumatology clinic of Istanbul University Medical Faculty Hospital and who meet the inclusion criteria will be included in our study.
Key inclusion criteria (6 listed)
- Volunteer
- Diagnosed with chronic rheumatological disease
- 6-18 ages
- Have reading and writing skills
- Residing in Turkey
Key exclusion criteria (2 listed)
- Have had lower extremity surgery in the past 6 months
- Have had lower extremity surgery in the past 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.
Primary outcome
Gait Outcomes Assessment List for Children with Lower-Limb Difference (GOAL-LD)
Time frame: Change from baseline to 7 day
It was developed by Dermott et al. The original version of the parent- and child-reported GOAL questionnaire used in this study, consists of 44 items across seven domains: (A) Walking and getting around, (B) Pain/Discomfort/Fatigue, (C) Physical Activities, Games \& Recreation, (D) Gait Appearance, (E) Use of Braces \& Assistive Devices, and (F) Body Image \& Self-Esteem.
6 Minute Walk Test (6 MWT)
Time frame: Baseline
The 6-minute walk test is a well-tolerated, easy-to-apply and simple test that shows the submaximal level of functional capacity. This test measures the distance that participants can walk quickly on a hard and flat surface in 6 minutes. Participants rest in a chair near the starting position for at least 10 minutes before the start of the test. Before and after the test, heart rate, blood pressure, saturation are measured, and fatigue level is determined with the Modified Borg scale. Participants are told how to perform the test. At the end of the test, the distance walked by the participants in 6 minutes will be recorded in meters.
10 Stair Climb Test (10SCT)
Time frame: Baseline
10 Stair Climb Test is a measure of ability to ascend and descend a flight of stairs. We will ask the patient to go walk as quickly as patients feel safe and comfortable to the top of the 10 stairs, and than turn around, and come back down. Physiotherapist will stop the clock when the patients second foot touches the landing. Seconds will recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- 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.
Nilay Arman, Assoc. Prof. principal investigator
Istanbul University-Cerrahpaşa, Faculty of Health Science
Asena Yekdaneh, Pt. MSc. study chair
Fenerbahce University
Asya Albayrak, Pt. MSc. study chair
Istanbul Kent University
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 Rheumatologic Disease and Pediatric ALL, run by Istanbul University - Cerrahpasa 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 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?
Results are not available in the source record.
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 for Children with Lower-Limb Difference (GOAL-LD) (time frame: Change from baseline to 7 day). The study lists 3 primary outcomes in all. 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 12 Dec 2023.