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

NCT05846672 | Unknown

• 1 other identifier: NAAAArman
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatologic Disease; Pediatric ALL; Children, Only; Lower Extremity Problem

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Volunteer
• Diagnosed with chronic rheumatological disease
• ages
• Have reading and writing skills
• Residing in Turkey
• To have the cognitive skills to understand and answer the questions in the questionnaires

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University Medical Faculty Hospital

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Collagen Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Nilay Arman, Assoc. Prof.

  Istanbul University-Cerrahpaşa, Faculty of Health Science

  PRINCIPAL INVESTIGATOR

• Asena Yekdaneh, Pt. MSc.

  Fenerbahce 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 CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 6, 2023
• Study Start: May 30, 2023
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2023
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)