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

September 2, 2024 updated by: Haydar Gok, Ankara University

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey, 06620
        • Recruiting
        • Ankara University School of Medicine Department of Physical Medicine and Rehabilitation
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Nur Akbas, Resident

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient group
Post-stroke patients
Diagnostic test: VR-based 9-hole peg 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test-retest reliability of the VR-based 9-hole peg test
Time Frame: Baseline and 7 days
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.
Baseline and 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Internal consistency of the VR-based 9-hole test
Time Frame: Baseline
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.
Baseline
Construct validity of the VR-based 9-hole test
Time Frame: Baseline
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).
Baseline
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.
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Study Director: Haydar Gok, Professor, Ankara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2023

Primary Completion (Estimated)

March 24, 2025

Study Completion (Estimated)

March 24, 2025

Study Registration Dates

First Submitted

September 2, 2024

First Submitted That Met QC Criteria

September 2, 2024

First Posted (Actual)

September 4, 2024

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

September 2, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I02-56-23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on VR-based 9-hole peg test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe