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Clinical Trials/NCT03845855
NCT03845855CompletedNot Applicable

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

Hacettepe University1 site in 1 country30 target enrollmentStarted: February 20, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
10 meter walk test

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
40 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Virtual reality with robotic gait

Experimental

virtual reality treatment with robotic gait therapy 2 times for week by 6 weeks.

Intervention: virtual reality (Other)

Virtual reality with robotic gait

Experimental

virtual reality treatment with robotic gait therapy 2 times for week by 6 weeks.

Intervention: robotic gait (Other)

Robotic gait therapy only

Active Comparator

only robotic gait therapy 2 times for week by 6 weeks

Intervention: robotic gait (Other)

Outcomes

Primary Outcomes

10 meter walk test

Time Frame: change from baseline time at the end of 6 week

The time is measured after 10 meter walk completed

10 meter walk test with cognitive task

Time Frame: change from baseline time at the end of 6 week

The time is measured after 10 meter walk with a cognitive task completed

10 meter walk test with motor task

Time Frame: change from baseline time at the end of 6 week

The time is measured after 10 meter walk with a motor task completed

Secondary Outcomes

  • Berg Balance Scale(change from baseline score at the end of 6 week)
  • Falls Efficacy Scale - International(change from baseline score at the end of 6 week)
  • Functional Ambulation Classification(change from baseline score at the end of 6 week)
  • Rivermead Mobility Index(change from baseline score at the end of 6 week)
  • Functional Gait Assessment(change from baseline score at the end of 6 week)
  • Mini Mental State Examination(change from baseline score at the end of 6 week)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Büşra Kayabınar

Lecturer

Hacettepe University

Study Sites (1)

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