Virtual Reality Mediated Functional Status Assessment in Stroke Patients

April 16, 2025 updated by: Ahmet Kivanc Menekseoglu, Istanbul University
The aim of the study is to investigate the applicability of virtual reality-mediated functional status assessment of patients diagnosed with stroke. Remote assessment of patients and remote rehabilitation (tele-rehabilitation) has an increasing application area in individuals with chronic neurological diseases. In this study, it was aimed to evaluate the upper extremity and balance functions of stroke patients with the developed software.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective and descriptive study will be conducted with patients diagnosed with stroke. Patients diagnosed with stroke will first be evaluated by an expert physiatrist in a clinical setting to determine their functional status, and then evaluated by a virtual reality mediated software system. The evaluation of a patient will take approximately 1 hour.

Participants diagnosed with stroke will be evaluated in terms of hand and balance functions. The measurement parameters planned to be performed are scales routinely applied in stroke patients. Hand functions of the users will be evaluated with the 'Wooden Box and Block Test' , lower extremity muscle strength and fall risk will be evaluated with the 'Sit and Stand Test for 5 Times', and balance functions will be evaluated with the '360 Degree Rotation Test' . The tests mentioned above will be presented to the users first in the real world and then in the virtual reality environment and an objective functional status assessment will be made.

A total of 30 patients diagnosed with stroke are planned to be included in the study.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Turkey
      • Istanbul, Turkey, 34015
        • Ahmet Kıvanç Menekşeoğlu

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

No

Description

Inclusion Criteria:

  • To be between the ages of 18-65,
  • History of stroke
  • Accept to participate in the study,

Exclusion Criteria:

  • Presence of known central nervous system or peripheral nervous system disease other than stroke, presence of progressive neurological deficit,
  • Uncontrolled hypertension, diabetes, cardiovascular disease etc.
  • Cognitive impairment causing difficulty in performing simple commands
  • Epilepsy
  • Pregnancy.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hemiplegia Group
Participants diagnosed with stroke will be evaluated with the Box and Block Test, 360 degree rotation test and 5 times squat test. These tests will be presented to the participants first in the real world and then in virtual reality.
Other: VR Assessment Tool
Participants diagnosed with stroke will be evaluated with the Box and Block Test, 360 degree rotation test and 5 times squat test. These tests will be presented to the participants first in the real world and then in virtual reality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Box and Block Test
Time Frame: 1 day
The Box and Block Test measures unilateral gross manual dexterity. It is calculated how many cubes the patient moves between the compartments in 1 minute with both hands separately.
1 day
360 degree rotation test
Time Frame: 1 day
It is a useful and practical test to evaluate the balance functions of patients. It is calculated how many seconds it takes the patient to complete one full round.
1 day
5 times Squat Test
Time Frame: 1 day
It is performed to evaluate the balance and lower extremity functions of the patients, and the number of seconds it takes to squat 5 times is calculated.
1 day

Collaborators and Investigators

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

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Ahmet Menekseoglu, MD, Kanuni Sultan Süleyman Research and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 1, 2024

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

January 20, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAEK/2022.11.222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data obtained as a result of the study will be used within the scope of academic study by protecting the personal information of the participants.

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.

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