Effects of Virtual Reality on Dual Task Performance

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: virtual reality; Other: robotic gait

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kozaklı
    • Nevşehir, Kozaklı, Turkey
      • Kozakli Fizik Tedavi Ve Rehabilitasyon Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Büşra Kayabınar, MSc, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2019
• Primary Completion (Actual): June 11, 2019
• Study Completion (Actual): June 11, 2019

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 16, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: stroke; virtual reality; dual task
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2018.09.97

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No