Effects of Virtual Reality on Dual Task Performance

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03845855
• Other study ID #: 2018.09.97
• Status: Completed
• Phase: N/A
• Start date: February 20, 2019
• Est. completion date: June 11, 2019

Study information

• Verified date: February 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 11, 2019
• Est. primary completion date: June 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• virtual reality
Virtual reality with a game
• robotic gait
robotic gait therapy

Locations

Country	Name	City	State
Turkey	Kozakli Fizik Tedavi Ve Rehabilitasyon Hastanesi	Nevsehir	Kozakli

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	10 meter walk test	The time is measured after 10 meter walk completed	change from baseline time at the end of 6 week
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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