Virtual Reality Mediated Functional Status Assessment in Stroke Patients

Not Applicable

Completed

• Conditions: Hemiplegia
• Interventions: Other: VR Assessment Tool

• Registration Number: NCT06244459
• Lead Sponsor: Istanbul University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-01-20
• Study First Submitted QC: 2024-01-29
• Study Start: 2024-02-01
• Study First Posted: 2024-02-06
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hemiplegia Group	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.

Primary Outcome Measures

Name	Time	Method
360 degree rotation test	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.
5 times Squat Test	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.
Box and Block Test	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.

Trial Locations

Locations (1)

Ahmet Kıvanç Menekşeoğlu; 🇹🇷 Istanbul, Turkey