Clinical trial NCT05846672: Turkish Cultural Adaptation, Validity and Reliability of the "Gait Outcomes Assessment List"
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rheumatologic Disease
Pediatric ALL
Children, Only
Lower Extremity Problem
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Have had lower extremity surgery in the past 6 months
* Have had lower extremity surgery in the past 6 months

Primary outcomes:
measure: Gait Outcomes Assessment List for Children with Lower-Limb Difference (GOAL-LD)
timeFrame: Change from baseline to 7 day
measure: 6 Minute Walk Test (6 MWT)
timeFrame: Baseline
measure: 10 Stair Climb Test (10SCT)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Medical Faculty Hospital
Study officials:
affiliation: Istanbul University-Cerrahpaşa, Faculty of Health Science
name: Nilay Arman, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fenerbahce University
name: Asena Yekdaneh, Pt. MSc.
role: STUDY_CHAIR
affiliation: Istanbul Kent University
name: Asya Albayrak, Pt. MSc.
role: STUDY_CHAIR
affiliation: Istanbul University Medical Faculty
name: Nuray Aktay Ayaz, Prof. Dr.
role: STUDY_CHAIR
affiliation: Aydın University
name: Ayşenur Namlı, Pt. MSc.
role: STUDY_CHAIR
affiliation: Istanbul University Medical Faculty
name: Fatma Gül Demirkan, MD
role: STUDY_CHAIR
affiliation: Istanbul University Medical Faculty
name: Özlem Akgün, MD
role: STUDY_CHAIR
References: