NCT06583772

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?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 4, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2025

Completed
Last Updated

September 4, 2024

Status Verified

September 1, 2024

Enrollment Period

1.8 years

First QC Date

September 2, 2024

Last Update Submit

September 2, 2024

Conditions

Stroke

Keywords

strokeVirtual realityNine-hole peg test

Outcome Measures

Primary Outcomes (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.

    Baseline and 7 days

Secondary Outcomes (3)

  • Internal consistency of the VR-based 9-hole test

    Baseline

  • Construct validity of the VR-based 9-hole test

    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.

    Baseline

Study Arms (1)

Patient group

Post-stroke patients

Diagnostic Test: VR-based 9-hole peg test

Interventions

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.

Patient group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University School of Medicine Department of Physical Medicine and Rehabilitation

Ankara, 06620, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Haydar Gok, Professor

    Ankara University

    STUDY DIRECTOR

Central Study Contacts

Haydar Gok, Professor

CONTACT

90+5325669722haydar.gok@gmail.com

Sehim Kutlay, Professor

CONTACT

905325625906sehim.kutlay@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

September 2, 2024

First Posted

September 4, 2024

Study Start

June 22, 2023

Primary Completion

March 24, 2025

Study Completion

March 24, 2025

Last Updated

September 4, 2024

Record last verified: 2024-09

Locations

TU(1)