Effects of Virtual Reality on Dual Task Performance
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
virtual reality
robotic gait
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring virtual reality, stroke, dual task
Eligibility Criteria
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
Sites / Locations
- Kozakli Fizik Tedavi Ve Rehabilitasyon Hastanesi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Virtual reality with robotic gait
Robotic gait therapy only
Arm Description
virtual reality treatment with robotic gait therapy 2 times for week by 6 weeks.
only robotic gait therapy 2 times for week by 6 weeks
Outcomes
Primary Outcome Measures
10 meter walk test
The time is measured after 10 meter walk completed
10 meter walk test with cognitive task
The time is measured after 10 meter walk with a cognitive task completed
10 meter walk test with motor task
The time is measured after 10 meter walk with a motor task completed
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03845855
Brief Title
Effects of Virtual Reality on Dual Task Performance
Official Title
The Investigation of the Effects of Virtual Reality Training on Dual Task Performance, Balance and Gait on Patients With Chronic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
June 11, 2019 (Actual)
Study Completion Date
June 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
virtual reality, stroke, dual task
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality with robotic gait
Arm Type
Experimental
Arm Description
virtual reality treatment with robotic gait therapy 2 times for week by 6 weeks.
Arm Title
Robotic gait therapy only
Arm Type
Active Comparator
Arm Description
only robotic gait therapy 2 times for week by 6 weeks
Intervention Type
Other
Intervention Name(s)
virtual reality
Intervention Description
Virtual reality with a game
Intervention Type
Other
Intervention Name(s)
robotic gait
Intervention Description
robotic gait therapy
Primary Outcome Measure Information:
Title
10 meter walk test
Description
The time is measured after 10 meter walk completed
Time Frame
change from baseline time at the end of 6 week
Title
10 meter walk test with cognitive task
Description
The time is measured after 10 meter walk with a cognitive task completed
Time Frame
change from baseline time at the end of 6 week
Title
10 meter walk test with motor task
Description
The time is measured after 10 meter walk with a motor task completed
Time Frame
change from baseline time at the end of 6 week
Secondary Outcome Measure Information:
Title
Mini Mental State Examination
Description
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.
Time Frame
change from baseline score at the end of 6 week
Title
Functional Ambulation Classification
Description
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.
Time Frame
change from baseline score at the end of 6 week
Title
Rivermead Mobility Index
Description
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.
Time Frame
change from baseline score at the end of 6 week
Title
Berg Balance Scale
Description
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.
Time Frame
change from baseline score at the end of 6 week
Title
Falls Efficacy Scale - International
Description
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.
Time Frame
change from baseline score at the end of 6 week
Title
Functional Gait Assessment
Description
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.
Time Frame
change from baseline score at the end of 6 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Büşra Kayabınar, MSc
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kozakli Fizik Tedavi Ve Rehabilitasyon Hastanesi
City
Nevşehir
State/Province
Kozaklı
Country
Turkey
12. IPD Sharing Statement
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Effects of Virtual Reality on Dual Task Performance
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