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OpenTrials
Completed

NCT Number: NCT06244459

Virtual Reality Mediated Functional Status Assessment in Stroke Patients

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahmet Kıvanç Menekşeoğlu

Istanbul, 34015, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VR Assessment Tool

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2024
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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