Effects of Virtual Reality on Dual Task Performance

Study Overview
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Brief Summary
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This study evaluates the effects of virtual reality treatment in addition to robotic gait therapy on dual task performance, balance and gait in chronic stroke patients. Half of participants will attend virtual reality treatment in addition to robotic gait therapy for 12 sessions, while the other half will attend only robotic gait therapy for 12 sessions.

Detailed Description
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Following stroke, motor disorders, balance disorders, falls, gait disturbances and cognitive disorders are frequently seen. In stroke rehabilitation, with the use of robots and virtual reality systems with conventional methods, it is aimed to increase patient's motivation, to check if exercise is effective, to provide objective evaluation data and to support the motor learning process and the use of these methods in the field of neurological rehabilitation is increasing. Multi-task evaluations can be made with the virtual environments created by virtual reality applications and complex tasks. The traditional approach to stroke rehabilitation is mainly focused on balance and gait training under single task conditions. In everyday life, people should not only have balance and mobility skills, but also have the ability to perform other cognitive and motor tasks with these skills. Therefore, traditional approaches are not sufficient for the individual to return to society after a stroke. In this respect, this study was planned in order to examine the effects of frequently used virtual reality treatment in addition to robotic gait therapy on the dual task, balance and gait performance.

Official Title
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The Investigation of the Effects of Virtual Reality Training on Dual Task Performance, Balance and Gait on Patients With Chronic Stroke

Conditions
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Stroke

Intervention / Treatment
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* Other: virtual reality
* Other: robotic gait


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteer to participate in the research Stroke for the first time To be able to walk independently before the disease To score 3 or above in the functional ambulation classification 6 months after stroke diagnosis Not having open wounds Severity of spasticity of the lower extremities to be 3 and below according to the Modified Asworth Scale To score 24 or more in the Mini Mental State Examination Exclusion Criteria: Acute internal problems, additional neurological diseases, or orthopedic problems that might limit walking To have received botulinum toxin treatment during 6 months before treatment or during treatment To have stroke on both sides To have neglect

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality with robotic gait<br>virtual reality treatment with robotic gait therapy 2 times for week by 6 weeks. | Other: virtual reality<br>* Virtual reality with a game<br>Other: robotic gait<br>* robotic gait therapy<br>|
| Active Comparator: Robotic gait therapy only<br>only robotic gait therapy 2 times for week by 6 weeks | Other: robotic gait<br>* robotic gait therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 meter walk test | The time is measured after 10 meter walk completed | change from baseline time at the end of 6 week | 
| 10 meter walk test with cognitive task | The time is measured after 10 meter walk with a cognitive task completed | change from baseline time at the end of 6 week | 
| 10 meter walk test with motor task | The time is measured after 10 meter walk with a motor task completed | change from baseline time at the end of 6 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini Mental State Examination | Mini Mental State Examination can be used to assess the mental status. Mini Mental State Examination is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30. The minimum score is 0. Getting 24 point is cut point. If a person get 24 points from examination, his/her mental status is fine. The higher scores represent better mental status. | change from baseline score at the end of 6 week | 
| Functional Ambulation Classification | This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. Level 0 is the minimum level and level 5 is the maximum level. Higher levels represent better function. | change from baseline score at the end of 6 week | 
| Rivermead Mobility Index | Rivermead Mobility Index assesses functional mobility in gait, balance and transfers after stroke. 14-self-reported items and 1 direct observation item are calculated. Items are coded as either 0 or 1, depending on whether the patient can complete the task according to specific instructions. Items receive a score of 0 for a No response and 1 for a Yes response.A maximum of 15 points is possible; higher scores indicate better mobility performance. | change from baseline score at the end of 6 week | 
| Berg Balance Scale | The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. | change from baseline score at the end of 6 week | 
| Falls Efficacy Scale - International | The Falls Efficacy Scale International are measures of fear of falling or, more properly, concerns about falling. Minimum 16 (no concern about falling) to maximum 64 (severe concern about falling) can be obtained. | change from baseline score at the end of 6 week | 
| Functional Gait Assessment | The Funcitonal Gait Assessment is used to assess postural stability during various walking tasks. The highest score is 30/30. Higher scores represent better functional gait performance. | change from baseline score at the end of 6 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality, stroke, dual task