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Completed

NCT Number: NCT03845855

Effects of Virtual Reality on Dual Task Performance

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kozakli Fizik Tedavi Ve Rehabilitasyon Hastanesi

Nevşehir, Kozaklı, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality

Other

Virtual reality with a game

robotic gait

Other

robotic gait therapy

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. Mini Mental State Examination

    Time frame: change from baseline score at the end of 6 week

    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.

  2. Functional Ambulation Classification

    Time frame: change from baseline score at the end of 6 week

    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.

  3. Rivermead Mobility Index

    Time frame: change from baseline score at the end of 6 week

    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.

  4. Berg Balance Scale

    Time frame: change from baseline score at the end of 6 week

    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.

  5. Falls Efficacy Scale - International

    Time frame: change from baseline score at the end of 6 week

    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.

  6. Functional Gait Assessment

    Time frame: change from baseline score at the end of 6 week

    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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2019
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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