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Clinical Trials in Turkey / NCT06588959
Starting soon Observational

6-minute Pegboard Ring Test in Patients With Scleroderma

NCT06588959 · tracked via the Priya Life Science Turkey tracker
Sponsor
Yasemin GEDIKLI
Phase
Observational
Started
2024-10-15
Last updated
2024-09-19

Condition(s) studied

Systemic Sclerosis (SSc)Scleroderma

Investigational drug(s) / intervention(s)

validity and reliability study

validity and reliability study: Determination of strength, endurance and exercise capacity of the upper extremities is an important issue in scleroderma management. 6PBRT, which is one of the tests serving this purpose, has been found to be valid and reliable in patients with chronic obstructive pulmonary disease and asthma, but when the literature is reviewed, it is seen that 6PBRT has not been studied in patients with scleroderma. This study was planned as a non-interventional safety study. The study will investigate the validity and reliability of 6PBRT in patients with scleroderma. In this context, the test will be performed 2 times with a 1-hour rest break. Dyspnea and fatigue will be assessed using the Borg scale and muscle oxygenation, heart rate and blood pressure will be recorded before and after 6PBRT. The level of dyspnea and fatigue and baseline values of heart rate will be checked before the second trial to ensure patients are stable. All assessments will be performed by the same physiotherapist.

Study summary

The aim of this observational study was to evaluate the reliability and validity of the 6-minute pegboard and ring test (6PBRT) in patients with systemic sclerosis. The main question it aims to answer is:

\- Is 6PBRT a valid and reliable method to assess upper extremity functional capacity in patients with systemic sclerosis? Participants will repeat the 6PBRT 2 times 1 hour apart. In addition, respiratory muscle strength (MIP-MEP), upper extremity muscle strength (hand dynanometer and hand-held dynanometer), muscle oxygen saturation (Moxy Monitor Device) will be evaluated.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Being between the ages of 18-75 * 2013 To be diagnosed with systemic sclerosis according to ACR/EULAR classification criteria * Being clinically stable * Ability to adapt to tests (visual, cognitive, cooperative) Exclusion Criteria: * Those with neurological and/or musculoskeletal problems that may affect the work * Presence of severe joint contracture or painful ulcers that may affect muscle strength measurement and walking * Presence of severe infection or sepsis * Being diagnosed with a known additional rheumatologic disease * Any stage of cancer * Pregnant or breastfeeding

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Selcuk University Konya Selcuklu

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06588959 on ClinicalTrials.gov ↗ ← All trials in Turkey