NCT06806774

Brief Summary

Juvenile Idiopathic Arthritis (JIA) is children's most common inflammatory rheumatic disease. The International League of Associations for Rheumatology (ILAR) defines it as a chronic arthritis condition that begins before the age of 16 lasts for six weeks or more, and has an unknown cause. Despite the gains made in the management of the disease of individuals with JIA with modern medical treatment methods, the physical and psychosocial problems caused by chronic inflammation negatively affect the daily living activities of individuals with JIA. On the other hand, in the JIA Core Set created by Outcome Measures in Rheumatology (OMERACT) in 2018, activities of daily living were included as a "mandatory area that should be evaluated in all studies." Therefore, to ensure that individuals with JIA reach a state of complete well-being, multi-interdisciplinary health professionals are expected to address the activities of daily living, identify the factors that limit these activities, and create intervention plans for the factors to be determined. The literature shows that the daily living activities of patients with JIA are addressed with a limited number of subjective measurement tools. However, these methods have disadvantages due to their subjectivity. In this case, objective measurement methods are needed to quantify the physical performance of patients with JIA in terms of their daily living activities. The Glittre Activities of Daily Living Test, initially developed by selecting activities similar to daily living activities to evaluate functional capacity in pulmonary diseases, has the potential to address this gap. Since the activities in the test require using both the lower and upper extremities, it has the advantage of reflecting functional capacity and providing information about performance in daily life activities. Although it has potential, the Glittre Activities of Daily Living Test needs appropriate psychometric properties for clinical settings and research for JIA patients. To our knowledge, no studies have been conducted in the current literature on the validity and reliability of the Glittre Activities of Daily Living Test in JIA patients. Therefore, this study aimed to evaluate the test-retest reliability, construct validity, and minimum detectable change of the Glittre Activities of Daily Living Test in assessing activities of daily living in children and adolescents with JIA.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Apr 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Apr 2025Oct 2026

First Submitted

Initial submission to the registry

January 29, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 10, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

1.6 years

First QC Date

January 29, 2025

Last Update Submit

April 10, 2025

Conditions

Keywords

activities of daily livingreliabilityvalidityjuvenile idiopathic arthritisfunctional capacity

Outcome Measures

Primary Outcomes (1)

  • The Glittre Activities of Daily Living Test

    The Glittre Activities of Daily Living Test is widely used in the literature to evaluate activities of daily living based on performance. The test consists of a cycle of standardized activities such as walking, weight-bearing, climbing stairs, and moving objects on shelves. It is a test that takes place over a total distance of 10 m divided into two parts by a ladder. The person completes the test cycle in 5 laps at this distance range. The time it takes for individuals to complete the test and their pre-and post-test heart rate, blood pressure, respiratory frequency, SpO2, and modified Borg Scale, as well as their dyspnea and fatigue levels during exertion, are evaluated. In our study, the Pediatric Glittre Activities of Daily Living Test will be used for individuals diagnosed with JIA between the ages of 8 and 14, and the standard version of the test will be used for JIA patients between the ages of 15 and 18.

    Baseline (First Assessment)

Secondary Outcomes (5)

  • Functional Reach Test

    Baseline (First assessment)

  • Six Minute Walk Test (6MWT)

    Baseline (First Assessment)

  • Childhood Health Assessment Questionnaire (CHAQ)

    Baseline (First Assessment)

  • Juvenile Arthritis Biopsychosocial Questionnaire (JAB-Q)

    Baseline (First Assessment)

  • Juvenile Arthritis Quality of Life Questionnaire (JAQQ)

    Baseline (First Assessment)

Study Arms (1)

Juvenile Idiopathic Arthritis (JIA)

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

The study population will consist of individuals with JIA who meet the inclusion criteria at the Department of Pediatrics, Division of Rheumatology, Hacettepe University Faculty of Medicine.

You may qualify if:

  • Being diagnosed with Juvenile Idiopathic Arthritis (JIA) according to The International League of Associations for Rheumatology (ILAR) classification
  • Being between the ages of 8-18
  • Volunteering to participate in research

You may not qualify if:

  • Advanced heart/lung/liver/kidney disease, neurological disease and malignancies
  • Having undergone major orthopedic surgery
  • Not volunteering to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

NOT YET RECRUITING

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Sinan Buran, MSc

    Hacettepe University Faculty of Physical Therapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edibe Ünal, Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 29, 2025

First Posted

February 4, 2025

Study Start

April 10, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

April 15, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations