Clinical trial NCT06244459: Virtual Reality Mediated Functional Status Assessment in Stroke Patients
Official title: Virtual Reality Mediated Functional Status Assessment in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia
Keywords: virtual reality
assessment
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Box and Block Test
timeFrame: 1 day
measure: 360 degree rotation test
timeFrame: 1 day
measure: 5 times Squat Test
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ahmet Kıvanç Menekşeoğlu
Study officials:
affiliation: Kanuni Sultan Suleyman Research and Training Hospital
name: Ahmet Menekseoglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.