StrokeNCT03845855
Effects of Virtual Reality on Dual Task Performance
A study testing virtual reality and robotic gait in people with Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- virtual reality and robotic gait
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2019to 11 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kozakli Fizik Tedavi Ve Rehabilitasyon Hastanesi
Nevşehir, Kozaklı
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- virtual reality, robotic gait
- Keywords
- virtual reality, stroke, dual task
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityOther
Virtual reality with a game
robotic gaitOther
robotic gait therapy
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality with robotic gait | Experimental | virtual reality treatment with robotic gait therapy 2 times for week by 6 weeks. Receives: Other: virtual reality; Other: robotic gait |
| Robotic gait therapy only | Active comparator | only robotic gait therapy 2 times for week by 6 weeks Receives: Other: robotic gait |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 meter walk test
The time is measured after 10 meter walk completed
Measured: 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
Measured: 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
Measured: change from baseline time at the end of 6 week
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: change from baseline score at the end of 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start20 Feb 2019
- Primary completion11 Jun 2019
- Study completion11 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Kayabınar, Hacettepe University
- Investigators
- Büşra Kayabınar, MSc, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845855
- Sponsor's protocol ID
- 2018.09.97
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2019
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of the Effects of Virtual Reality Training on Dual Task Performance, Balance and Gait on Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT03845855
- Acronym / sponsor ID
- 2018.09.97
- Conditions
- Stroke
- Keywords
- virtual reality, stroke, dual task
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 11 Jun 2019 (actual)
- Study completion
- 11 Jun 2019 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality with robotic gait | Experimental | Other: virtual reality, Other: robotic gaitvirtual reality treatment with robotic gait therapy 2 times for week by 6 weeks. |
| Robotic gait therapy only | Active comparator | Other: robotic gaitonly robotic gait therapy 2 times for week by 6 weeks |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual realityVirtual reality with a game | Other | Virtual reality with robotic gait |
| robotic gaitrobotic gait therapy | Other | Robotic gait therapy only, Virtual reality with robotic gait |
Primary outcome
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
6 secondary outcomes
Mini Mental State Examination
Time frame: change from baseline score at the end of 6 week
Functional Ambulation Classification
Time frame: change from baseline score at the end of 6 week
Rivermead Mobility Index
Time frame: change from baseline score at the end of 6 week
Berg Balance Scale
Time frame: change from baseline score at the end of 6 week
Falls Efficacy Scale - International
Time frame: change from baseline score at the end of 6 week
Functional Gait Assessment
Time frame: change from baseline score at the end of 6 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Büşra Kayabınar, MSc principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality and robotic gait in people with Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 meter walk test (time frame: change from baseline time at the end of 6 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024; AzTrials last refreshed its copy on 30 Oct 2026.