Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583772
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Validity and Reliability of the Virtual Reality-Based 9-Hole Peg Test in Stroke Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validity and Reliability of the BeCureTM Virtual Reality-Based 9-Hole Peg Test in Stroke Patients
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Parkinsons 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None