Virtual Reality Mediated Functional Status Assessment in Stroke Patients

Hemiplegia Clinical Trial

Official title:

Virtual Reality Mediated Functional Status Assessment in Stroke Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06244459
• Other study ID #: KAEK/2022.11.222
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: April 1, 2024

Study information

• Verified date: February 2024
• Source: Istanbul University
• Contact: Ahmet Menekseoglu, MD
• Phone: 5378192424
• Email: kivancmenekseoglu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 50 patients diagnosed with stroke are planned to be included in the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemiplegia

Intervention

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.

Locations

Country	Name	City	State
Turkey	Ahmet Kivanç Menekseoglu	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Dite W, Temple VA. Development of a clinical measure of turning for older adults. Am J Phys Med Rehabil. 2002 Nov;81(11):857-66; quiz 867-8. doi: 10.1097/00002060-200211000-00010. — View Citation

Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386. — View Citation

Mong Y, Teo TW, Ng SS. 5-repetition sit-to-stand test in subjects with chronic stroke: reliability and validity. Arch Phys Med Rehabil. 2010 Mar;91(3):407-13. doi: 10.1016/j.apmr.2009.10.030. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Box and Block Test	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
Primary	360 degree rotation test	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
Primary	5 times Squat Test	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