Clinical trial NCT06583772: Validity and Reliability of the Virtual Reality-Based 9-Hole Peg Test in Stroke Patients
Official title: Validity and Reliability of the BeCureTM Virtual Reality-Based 9-Hole Peg Test in Stroke Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: stroke
Virtual reality
Nine-hole peg test
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

Brief 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 when compared to the physical version of it.
* Does the VR-based 9HPT differ between the dominant and non-dominant hand in healthy individuals?

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.

Eligibility criteria: 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

Primary outcomes:
measure: Test-retest reliability of the VR-based 9-hole peg test
timeFrame: Baseline and 7 days
Secondary outcomes:
measure: Internal consistency of the VR-based 9-hole test
timeFrame: Baseline
measure: Construct validity of the VR-based 9-hole test
timeFrame: Baseline
measure: 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.
timeFrame: Baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University School of Medicine Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Ankara University
name: Haydar Gok, Professor
role: STUDY_DIRECTOR
References: