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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05846672
Other study ID # NAAAArman
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 30, 2023
Est. completion date December 30, 2023

Study information

Verified date December 2023
Source Istanbul University - Cerrahpasa (IUC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date December 30, 2023
Est. primary completion date October 30, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility 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

Study Design


Locations

Country Name City State
Turkey Istanbul University Medical Faculty Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from baseline to 7 day
Primary 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. Baseline
Primary 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. Baseline
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