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StrokeNCT06583772

Validity and Reliability of the Virtual Reality-Based 9-Hole Peg Test in Stroke Patients

An observational study of Stroke, run by Ankara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this observational study is to demonstrate diagnostic value of a VR-based 9-hole peg test (9HPT) for the evaluation of manual dexterity in stroke patients. The main questions it aims to answer are: Is the VR-based 9HPT a reliable and valid diagnostic tool to evaluate manual dexterity in stroke patients… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
VR-based 9-hole peg test
How many people
46 participants
Where
1 siteTurkey (Türkiye)
Study dates
22 Jun 2023to 24 Mar 2025
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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Post-stroke patients consecutively admitted to Ankara University Faculty of Medicine, Department of Physical Medicine and Rehabilitation will be included in the study.

Who may be able to join

  • Receiving a stroke diagnosis according to the WHO definition
  • Upper extremity in stage 3 and above according to Brunnstrom motor staging
  • To be cognitively competent (score of 22 or above on the Mini Mental Test)
  • Balance of sitting
  • The patient or his/her relatives have completed the informed voluntary consent form

Who cannot join

  • Presence of severe aphasia
  • Presence of cognitive impairment or psychiatric disorders
  • Detection of a neglect phenomenon
  • Presence of hemianopsia
  • Spasticity in the affected arm, 3 or more according to Modified Ashworth Scale

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara University School of Medicine Department of Physical Medicine and Rehabilitation

    Ankara, Ankara, 06620

Other trials in Turkey (Türkiye)

About this study

Official title: Validity and Reliability of the BeCureTM Virtual Reality-Based 9-Hole Peg Test in Stroke Patients

The goal of this observational study is to demonstrate diagnostic value of a VR-based 9-hole peg test (9HPT) for the evaluation of manual dexterity in stroke patients.

The main questions it aims to answer are:

  • Is the VR-based 9HPT a reliable and valid diagnostic tool to evaluate manual dexterity in stroke patients when compared to the physical version of it.
  • Does the VR-based 9HPT differ between the dominant and non-dominant hand in healthy individuals?
Read the detailed description

The 9-hole peg test (9HPT) is a method used to assess finger dexterity in patients with various neurological diseases, including stroke, Parkinson's disease, and cerebral palsy. Additionally, this test evaluates strength, visual attention, depth perception, sensory perception, and motor coordination.

The psychometric properties of the 9HPT were evaluated in healthy normal subjects and stroke patients in various studies. The results of these suggest that the 9HPT may be a reliable, valid and responsive measure in patients with stroke. Although the test is relatively straightforward to administer, it does have a number of disadvantages. The patient may knock over the test tools, take more than one peg at a time, use both hands, start to remove the pegs back before filling all the holes, or drop the pegs on the floor. Furthermore, errors in time measurement may occur due to the tester performance. The latest developments in technology have led to the creation of electronic and virtual reality (VR) based versions of the 9HPT. These new versions have eliminated the disadvantages of the original test, allow for the storage of measurement results, and provide a way to track the treatment process both in the hospital and remotely. However, studies on the validity and reliability of these tests in individuals with neurological diseases remain limited. The aim of this study is therefore to demonstrate the validity and reliability of a VR-based 9HPT for the evaluation of manual dexterity in stroke patients. The secondary aims were to determine the normative values of the test in healthy individuals and to reveal whether there is a difference between the dominant and non-dominant hand.

The study is a cross-sectional observational trial. Post-stroke patients who applied to the Ankara University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation will be included in the study. Socio-demographic data such as gender, age, education level, occupation, background, duration of stroke, type of lesion, and history of comorbidities will be recorded. All patients will be evaluated at the beginning and after 7 days. The state of consciousness, orientation and cooperation will be evaluated on the physical examination and the patients will be given a Mini Mental Test. Participants who score 22 points or more on this assessment will be included in this study. Brunnstrom motor staging will be performed for motor assessment of stroke patients. The Modified Ashworth Scale will be used to assess spasticity. Accordingly, participants with spasticity grade 3 and above in the upper extremity will be excluded from the study. The participants will first undergo a physical 9HPT. After the physical test is completed, a VR-based 9HPT will be performed. A laptop computer, motion controller, and BecureTM software will be used for this purpose. Through a motion sensor (Leap Motion Controller) positioned on the table and not touching the participant, the upper extremity and hand movements will be reflected on the computer screen. During the test, participants will first practice 2 times and then be tested. The test will be repeated 3 times and the average value will be recorded in seconds. The test will be repeated in the same way after 7 days.

Conditions
Stroke
Being tested
VR-based 9-hole peg test
Keywords
stroke, Virtual reality, Nine-hole peg test
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VR-based 9-hole peg testDiagnostic test

    The volunteers will first undergo a physical 9-hole peg test. After the physical test is completed, the VR-based 9-hole peg test will be performed.

Study groups in NCT06583772
Study groupRoleWhat they receive
Patient groupPost-stroke patients
Receives: Diagnostic Test: VR-based 9-hole peg test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Test-retest reliability of the VR-based 9-hole peg test

    Scoring is based on the time taken to complete the VR based 9-hole peg test activity, recorded in seconds. The volunteers will first undergo a physical 9-hole peg test. After the physical test is completed, the VR-based 9-hole peg test will be performed. In this application, patients will first practice 2 times and then be tested. The test will be repeated 3 times and the average value will be recorded in seconds. The test will be repeated in the same way after 7 days. To determine the reliability of the test, an intra-class correlation coefficient-ICC will be calculated.

    Measured: Baseline and 7 days

Secondary outcomes (3)
  1. Internal consistency of the VR-based 9-hole test

    Scoring is based on the time taken to complete the VR based 9-hole peg test activity, recorded in seconds. The volunteers will first undergo a physical 9-hole peg test. After the physical test is completed, the VR-based 9-hole peg test will be performed. In this application, patients will first practice 2 times and then be tested. The test will be repeated 3 times and the average value will be recorded in seconds. To determine the internal consistency of the test, Cronbach's alpha coefficient will be calculated.

    Measured: Baseline

  2. Construct validity of the VR-based 9-hole test

    Scoring is based on the time taken to complete the VR based 9-hole peg test activity, recorded in seconds. The volunteers will first undergo a physical 9-hole peg test. After the physical test is completed, the VR-based 9-hole peg test will be performed. The criterion validity of the test will be calculated by its agreement with the physical 9-hole peg test (Spearman's rank correlation).

    Measured: Baseline

  3. To determine the normative values of the virtual reality-based 9-hole peg test in healthy individuals and to reveal whether there is a difference between dominant and non-dominant hand.

    In age- and gender-matched healthy volunteers, the VR-based 9-hole peg test test will be performed on both the dominant and non-dominant hand. Scoring is based on the time taken to complete the VR based 9-hole peg test activity, recorded in seconds.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2024
  2. Study start22 Jun 2023
  3. Primary completion24 Mar 2025
  4. Study completion24 Mar 2025

Resources

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
Case only
Time perspective
Cross-sectional
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06583772
Sponsor's protocol ID
I02-56-23
Status last verified
Oct 2026
First submitted
2 Sep 2024
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Ankara 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 5 inclusion and 5 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 14 Oct 2026. 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?

Test-retest reliability of the VR-based 9-hole peg test (time frame: Baseline and 7 days). 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 14 Oct 2026.

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Clinical Trial NCT06583772 | AzTrials