HealthyNCT06319092
Immersive Virtual Reality Version of the 6 Minute Pegboard and Ring Test
An observational study of Healthy, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: consists of volunteer healthy individuals.
Who may be able to join
- 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)
Who cannot join
- Not completing 18 years of age
- not willing to volunteer to study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep İslamic Science and Technology University
Gaziantep, Şahinbey, 27000
About this study
Official title: Validity and Reliability of an Immersive Virtual Reality Version of the 6 Minute Pegboard and Ring Test in Healthy Subjects
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.
Read the detailed 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.
- Conditions
- Healthy
- Keywords
- 6 pegboard and ring test, upper extremity functional capacity, Healthy, handgrip
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: A total of one measurements will be made at 1-week
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
Measured: A total of two measurements will be made at 1-week intervals within 6 months.
Secondary outcomes (3)
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
Measured: A total of two measurements will be made at 1-week intervals within 6 months
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.
Measured: A total of two measurements will be made at 1-week intervals within 6 months
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
Measured: A total of two measurements will be made at 1-week intervals within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Jun 2023
- Primary completion1 Oct 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziantep Islam Science and Technology University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağtay Maden, Gaziantep Islam Science and Technology University
- Investigators
- Çağtay MADEN, PhD, Principal investigator, Gaziantep İslamic Science and Technology University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319092
- Sponsor's protocol ID
- 2023/175
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of an Immersive Virtual Reality Version of the 6 Minute Pegboard and Ring Test in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06319092
- Acronym / sponsor ID
- 2023/175
- Conditions
- Healthy
- Keywords
- 6 pegboard and ring test, upper extremity functional capacity, Healthy, handgrip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gaziantep Islam Science and Technology UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- consists of volunteer healthy individuals.
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (2 listed)
- Not completing 18 years of age
- not willing to volunteer to study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
6 Minute Pegboard and Ring Test
Time frame: A total of one measurements will be made at 1-week
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.
Immersive virtual reality version of the 6 Minute Pegboard and Ring Test
Time frame: A total of two measurements will be made at 1-week intervals within 6 months.
The classic 6-minute pegboard and ring test adapted to the virtual environment
3 secondary outcomes
Quick Shoulder-Hand Syndromes Questionnaire
Time frame: A total of two measurements will be made at 1-week intervals within 6 months
Assessment of handgrip
Time frame: A total of two measurements will be made at 1-week intervals within 6 months
9 Hole Peg Test
Time frame: A total of two measurements will be made at 1-week intervals within 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Çağtay MADEN, PhD principal investigator
Gaziantep İslamic Science and Technology University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Pegboard and Ring Test (time frame: A total of one measurements will be made at 1-week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.