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.
