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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06319092
Other study ID # 2023/175
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date December 1, 2023

Study information

Verified date March 2024
Source Gaziantep Islam Science and Technology University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The 6 Minute Pegboard and Ring Test is a test applicable to the upper extremities. The upper extremity plays an important role in activities of daily living, especially in tasks related to reaching, grasping and holding objects. Various activities of daily living, such as combing hair, brushing teeth and picking up objects, require supported or unsupported upper limb activity. Therefore, evaluation of upper extremity function is important. In addition, it is a simple test, it is also seen as a game, its application is functional, and there is no need for expensive equipment. Its validity and reliability have been demonstrated only for patients with Chronic Obstructive Pulmonary Disease (COPD) and healthy adults. In addition, to the best of our knowledge, the suitability of this test in a virtual environment has not been evaluated in the literature. Therefore, the main aim of this study is to examine the applicability of this test in a virtual environment.


Description:

6 Minutes The virtual reality space for the Pegboard Ring Test will be designed in Blender programme. The software and integration that provides the interactive movement of the person in the application will be done by the UNITY programme. Entry to the prepared training test area will be with OCULUS Quest 2 (virtual reality glasses and console) equipment.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - No orthopaedic problem or limitation of movement in the upper extremity that would adversely affect the test 6PBRT, - no diagnosis or history of symptomatic lung and/or heart disease, - no serious visual and hearing problems, - no psychological and epileptic illnesses, - not being diagnosed with migraine before, - body mass index (BMI > 20.34, kg/m2 and < 25.94 kg/m2 for male individuals; BMI > 14.6 kg/m2 and < 25.55 kg/m2 for female individuals) Exclusion Criteria: - Not completing 18 years of age - not willing to volunteer to study.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Gaziantep Islamic Science and Technology University Gaziantep Sahinbey

Sponsors (1)

Lead Sponsor Collaborator
Gaziantep Islam Science and Technology University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 6 Minute Pegboard and Ring Test The 6-minute pegboard and ring test is used to assess upper extremity functional capacity. The patient sat in front of a perforated board with bottom pegs at shoulder level. The upper pegs are placed in the hole 20 cm above the lower pegs. 10 rings of the same size are placed on the lower pegs. The patient is asked to move as many rings as possible from the lower pegs to the upper pegs and vice versa within a 6-minute period. Pulse, blood pressure, SpO2, dyspnea and arm fatigue detection are recorded before/after each test. Before the actual test, patients are allowed to move up and down the rings in a cycle to become familiar with the testing procedure. If the patient wants to rest during the test, he is allowed, but the stopwatch is not stopped. During the test, standard encouraging phrases are said to the patient at the end of each minute. A total of one measurements will be made at 1-week
Primary Immersive virtual reality version of the 6 Minute Pegboard and Ring Test The classic 6-minute pegboard and ring test adapted to the virtual environment A total of two measurements will be made at 1-week intervals within 6 months.
Secondary Quick Shoulder-Hand Syndromes Questionnaire The Quick Shoulder-Hand Syndromes Questionnaire is used to evaluate musculoskeletal physical function and symptoms of the upper extremity. The survey consists of 11 items and is scored between 0-100 points. Higher scores indicate more disability A total of two measurements will be made at 1-week intervals within 6 months
Secondary Assessment of handgrip Hand grip strength was evaluated with a dynamometer. The best score was recorded by taking 3 measurements separately for left and right hand. A total of two measurements will be made at 1-week intervals within 6 months
Secondary 9 Hole Peg Test The 9-hole peg test is a standardised test that measures fine dexterity against time. It is a simple test and is a valid and reliable method of assessment. Both hands are tested in the assessment A total of two measurements will be made at 1-week intervals within 6 months
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