Turkish Cultural Adaptation, Validity and Reliability of the "Gait Outcomes Assessment List"

December 10, 2023 updated by: Nilay Arman, Istanbul University - Cerrahpasa (IUC)

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34093
        • Istanbul University Medical Faculty Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to 7 day
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nilay Arman, Assoc. Prof., Istanbul University-Cerrahpaşa, Faculty of Health Science
  • Study Chair: Asena Yekdaneh, Pt. MSc., Fenerbahçe University
  • Study Chair: Asya Albayrak, Pt. MSc., Istanbul Kent University
  • Study Chair: Nuray Aktay Ayaz, Prof. Dr., Istanbul University Medical Faculty
  • Study Chair: Ayşenur Namlı, Pt. MSc., Aydın University
  • Study Chair: Fatma Gül Demirkan, MD, Istanbul University Medical Faculty
  • Study Chair: Özlem Akgün, MD, Istanbul University Medical Faculty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2023

Primary Completion (Actual)

October 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

April 27, 2023

First Submitted That Met QC Criteria

April 27, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 10, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • NAAAArman

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pediatric ALL

Subscribe