StrokeNCT05419791
The Effects of Lokomat Virtual Reality Applications on Balance and Gait in Stroke Patients
A study testing Robot Asisted Gait Training with Lokomat (Endurance), Robot Asisted Gait Training with Lokomat (Attention and Motivation) and Robot Asisted Gait Training with Lokomat (Activity Timing) in people with Stroke, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The effectiveness of applying robot-assisted walking training together with conventional physiotherapy is widely accepted. Virtual reality is another component and its contribution to rehabilitation is important. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Stroke
- What is being tested?
- Robot Asisted Gait Training with Lokomat (Endurance), Robot Asisted Gait Training with Lokomat (Attention and Motivation) and Robot Asisted Gait Training with Lokomat (Activity Timing)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2021to 1 Jun 2022
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis is stroke
- The time period have to be chronic period (+6 months)
- The patient must have the ability to walk with or without support
- The patiens should be able to understand Lokomat exercises
Who cannot join
- Any condition that may prevent walking with Lokomat
- Not volunteering to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
The effectiveness of applying robot-assisted walking training together with conventional physiotherapy is widely accepted. Virtual reality is another component and its contribution to rehabilitation is important. When we look at the literature on virtual reality applications on balance and walking, it is seen that some systems are beneficial while some systems have no effect. This raises the possibility that virtual reality applications may produce different results due to the task in the exercise, patient motivation or any other reason. There is a need to investigate whether virtual reality applications have different effects, if any, what is the source of this and what care should be taken in the development of these applications in the future. Therefore, we focused on investigating the different effects of Lokomat virtual reality applications.
Read the detailed description
Stroke is an important health problem worldwide. Emotional, cognitive, sensory and motor problems occur with stroke. Motor problems are especially balance and walking problems and they are related to each other. So balance and gait rehabilitation are primary goals in stroke.
Although the first study to support the efficacy of Lokomat is that Lokomat is superior to conventional physiotherapy in walking, there are also studies reporting that there is no difference between the effects of Lokomat and conventional physiotherapy and that conventional physiotherapy is superior. In the light of all these studies, the effectiveness of applying robotic systems together with conventional physiotherapy is widely accepted.
Robot Assisted Walking Training has many components such as guiding force, walking speed, body weight support. Virtual reality is one of these components and there is literature in which Lokomat virtual reality applications are effective on balance and walking. Although the virtual reality effect is emphasized for Lokomat, there is a lack of literature on the specific effect of different virtual reality applications. In our study, it was aimed to examine the changes caused by different Lokomat virtual reality applications in the spatiotemporal parameters of balance and gait.
Method: This study was conducted to examine the effects of Lokomat VR applications on balance and spatiotemporal parameters of gait in patients with chronic stroke; It is a prospective, randomized controlled, single-blind study. The study will be carried out in a single-blind manner, and the evaluator will not know which group the individual is in. 56 individuals with chronic stroke included our study. All individuals have been informed about the study and read and signed the consent form stating that they voluntarily participated in the study. For balance evaluation we used Berg Balance Scale and Huber 360 device, which measures postural stability and limits of stability. And for gait evaluation we used 10 MWT, 6 MWT and spatiotemporal gait analysis for C-Mill VR+.
- Conditions
- Stroke
- Being tested
- Robot Asisted Gait Training with Lokomat (Endurance), Robot Asisted Gait Training with Lokomat (Attention and Motivation), Robot Asisted Gait Training with Lokomat (Activity Timing), Conventional Physiotherapy
- Keywords
- Augmented performance feedback, Lokomat, Stroke, Rehabilitation, Virtual Reality
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot Asisted Gait Training with Lokomat (Endurance)Other
- Faster application (using for Endurance) : 3 days in a week for 6 weeks,very season was 40 min.
- Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
Robot Asisted Gait Training with Lokomat (Attention and Motivation)Other
- Smile application (using for Attetion and Motivation) : 3 days in a week for 6 weeks,very season was 20 min.
- Gabarello application (using for Attetion and Motivation) : 3 days in a week for 6 weeks,very season was 20 min.
- Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
Robot Asisted Gait Training with Lokomat (Activity Timing)Other
- High Flyer application (using for Activity Timing) : 3 days in a week for 6 weeks,very season was 20 min.
- Treasures application (using for Activity Timing) : 3 days in a week for 6 weeks,very season was 10 min.
- Curve Pursuit application (using for Activity Timing) : 3 days in a week for 6 weeks,very season was 10 min.
- Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
Conventional PhysiotherapyOther
-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
| Study group | Role | What they receive |
|---|---|---|
| Lokomat Group I (Endurance) | Experimental | * Faster application used with Lokomat gait training
* Conventional Physiotherapy Receives: Other: Robot Asisted Gait Training with Lokomat (Endurance); Other: Conventional Physiotherapy |
| Lokomat Group II (Attention and Motivation) | Experimental | * Smile and Gabarello applications used with Lokomat gait training
* Conventional Physiotherapy Receives: Other: Robot Asisted Gait Training with Lokomat (Attention and Motivation); Other: Conventional Physiotherapy |
| Lokomat Group III (Activity Timing) | Experimental | * High Flyer, Curve Pursuit and Treasures applications used with Lokomat gait training
* Conventional Physiotherapy Receives: Other: Robot Asisted Gait Training with Lokomat (Activity Timing); Other: Conventional Physiotherapy |
| Control | Other | -Only Conventional Physiotherapy Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6 MWT
6 Minutes Walk Test is a test using for walking distance. We evaluated the change in walking distance with 6 MWT.
Measured: 6 weeks after treatment
Change in 10 MWT
10 MWT is a test using for evaluate the gait speed. Gait speed is a spatiotemporal parameter.
Measured: 6 weeks after treatment
Change in BBS
Berg Balance Scale used for balance assesment. The scale consists of 14 items and each item gets a score between 0-4. As a result, the person evaluated gets a score between 0-56 on the berg balance scale. A higher score means the person has better balance skills.
Measured: 6 weeks after treatment
Change in Limits of Stability
Limits of Stability (LoS) are defined as the points at which the center of gravity (CoG) approaches the limits of the base of support (BoS) and a correction strategy is required to return the center of mass (CoM) to within the BoS. In other words, LoS is the amount of maximum excursion an individual is able to intentionally cover in any direction without losing his/her balance or taking a step. We used Huber 360 device to evaluate the LoS.
Measured: 6 weeks after treatment
Change in Spatiotemporal Gait Analysis
Spatiotemporal gait analysis gives spatial (distance) parameters along with temporal (time) parameters.
- Spatial parameters:
- Step Length
- Step Width
- Stride Length
- Temporal Parameters
- Step Time
- Stride Time
- Stance Time
- Swing Time
- Double Support Time We used C-Mill device to evaluate the spatiotemporal parameters.
Measured: 6 weeks after treatment
Secondary outcomes (3)
Change in Spatial Symmetry
It is the ratio of the hemiplegic side step lenght to the non-hemiplegic side step lenght.
Measured: 6 weeks after treatment
Change in Temporal Symmetry
For temporal symmetry we used the description "Gait Symmetry". Gait symmetry is calculated by the ratio of the hemiplegic side sway phase to the hemiplegic side stance phase ratio and the ratio of the non-hemiplegic side sway phase to the non-hemiplegic side stance phase ratio.
Measured: 6 weeks after treatment
Change in Postural Stability
Postural stability refers to the ability to maintain your body in a position to effectively complete a task or demand, using large muscle groups at the shoulders, trunk, and hips. We used Huber 360 device to evaluate the postural staiblity. The assesments were combination of opened and closed eyes. We recorded the COP vellocity and area.
Measured: 6 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start11 Nov 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
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.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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
- Model description
- Individuals have been assigned to groups by Research Randomizer program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Responsible party
- Principal investigator, Murat Akıncı, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419791
- Sponsor's protocol ID
- Lokomat VR
- Status last verified
- Nov 2022
- First submitted
- 8 Jun 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lokomat Virtual Reality Applications on Balance and Gait in Stroke Patients
- ClinicalTrials.gov ID
- NCT05419791
- Acronym / sponsor ID
- Lokomat VR
- Conditions
- Stroke
- Keywords
- Augmented performance feedback, Lokomat, Stroke, Rehabilitation, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 15 Jun 2022 (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.
The effectiveness of applying robot-assisted walking training together with conventional physiotherapy is widely accepted. Virtual reality is another component and its contribution to rehabilitation is important. When we look at the literature on virtual reality applications on balance and walking, it is seen that some systems are beneficial while some systems have no effect. This raises the possibility that virtual reality applications may produce different results due to the task in the exercise, patient motivation or any other reason. There is a need to investigate whether virtual reality applications have different effects, if any, what is the source of this and what care should be taken in the development of these applications in the future. Therefore, we focused on investigating the different effects of Lokomat virtual reality applications.
Detailed description
Stroke is an important health problem worldwide. Emotional, cognitive, sensory and motor problems occur with stroke. Motor problems are especially balance and walking problems and they are related to each other. So balance and gait rehabilitation are primary goals in stroke.
Although the first study to support the efficacy of Lokomat is that Lokomat is superior to conventional physiotherapy in walking, there are also studies reporting that there is no difference between the effects of Lokomat and conventional physiotherapy and that conventional physiotherapy is superior. In the light of all these studies, the effectiveness of applying robotic systems together with conventional physiotherapy is widely accepted.
Robot Assisted Walking Training has many components such as guiding force, walking speed, body weight support. Virtual reality is one of these components and there is literature in which Lokomat virtual reality applications are effective on balance and walking. Although the virtual reality effect is emphasized for Lokomat, there is a lack of literature on the specific effect of different virtual reality applications. In our study, it was aimed to examine the changes caused by different Lokomat virtual reality applications in the spatiotemporal parameters of balance and gait.
Method: This study was conducted to examine the effects of Lokomat VR applications on balance and spatiotemporal parameters of gait in patients with chronic stroke; It is a prospective, randomized controlled, single-blind study. The study will be carried out in a single-blind manner, and the evaluator will not know which group the individual is in. 56 individuals with chronic stroke included our study. All individuals have been informed about the study and read and signed the consent form stating that they voluntarily participated in the study. For balance evaluation we used Berg Balance Scale and Huber 360 device, which measures postural stability and limits of stability. And for gait evaluation we used 10 MWT, 6 MWT and spatiotemporal gait analysis for C-Mill VR+.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Individuals have been assigned to groups by Research Randomizer program.
| Arm | Type | Receives |
|---|---|---|
| Lokomat Group I (Endurance) | Experimental | Other: Robot Asisted Gait Training with Lokomat (Endurance), Other: Conventional Physiotherapy* Faster application used with Lokomat gait training * Conventional Physiotherapy |
| Lokomat Group II (Attention and Motivation) | Experimental | Other: Robot Asisted Gait Training with Lokomat (Attention and Motivation), Other: Conventional Physiotherapy* Smile and Gabarello applications used with Lokomat gait training * Conventional Physiotherapy |
| Lokomat Group III (Activity Timing) | Experimental | Other: Robot Asisted Gait Training with Lokomat (Activity Timing), Other: Conventional Physiotherapy* High Flyer, Curve Pursuit and Treasures applications used with Lokomat gait training * Conventional Physiotherapy |
| Control | Other | Other: Conventional Physiotherapy-Only Conventional Physiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (2 listed)
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 |
|---|---|---|
| Robot Asisted Gait Training with Lokomat (Endurance)* Faster application (using for Endurance) : 3 days in a week for 6 weeks,very season was 40 min. * Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min. | Other | Lokomat Group I (Endurance) |
| Robot Asisted Gait Training with Lokomat (Attention and Motivation)* Smile application (using for Attetion and Motivation) : 3 days in a week for 6 weeks,very season was 20 min. * Gabarello application (using for Attetion and Motivation) : 3 days in a week for 6 weeks,very season was 20 min. * Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min. | Other | Lokomat Group II (Attention and Motivation) |
| Robot Asisted Gait Training with Lokomat (Activity Timing)* High Flyer application (using for Activity Timing) : 3 days in a week for 6 weeks,very season was 20 min. * Treasures application (using for Activity Timing) : 3 days in a week for 6 weeks,very season was 10 min. * Curve Pursuit application (using for Activity Timing) : 3 days in a week for 6 weeks,very season was 10 min. * Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min. | Other | Lokomat Group III (Activity Timing) |
| Conventional Physiotherapy-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min. | Other | Control, Lokomat Group I (Endurance), Lokomat Group II (Attention and Motivation), Lokomat Group III (Activity Timing) |
Primary outcome
Change in 6 MWT
Time frame: 6 weeks after treatment
6 Minutes Walk Test is a test using for walking distance. We evaluated the change in walking distance with 6 MWT.
Change in 10 MWT
Time frame: 6 weeks after treatment
10 MWT is a test using for evaluate the gait speed. Gait speed is a spatiotemporal parameter.
Change in BBS
Time frame: 6 weeks after treatment
Berg Balance Scale used for balance assesment. The scale consists of 14 items and each item gets a score between 0-4. As a result, the person evaluated gets a score between 0-56 on the berg balance scale. A higher score means the person has better balance skills.
Change in Limits of Stability
Time frame: 6 weeks after treatment
Limits of Stability (LoS) are defined as the points at which the center of gravity (CoG) approaches the limits of the base of support (BoS) and a correction strategy is required to return the center of mass (CoM) to within the BoS. In other words, LoS is the amount of maximum excursion an individual is able to intentionally cover in any direction without losing his/her balance or taking a step. We used Huber 360 device to evaluate the LoS.
Change in Spatiotemporal Gait Analysis
Time frame: 6 weeks after treatment
Spatiotemporal gait analysis gives spatial (distance) parameters along with temporal (time) parameters. * Spatial parameters: * Step Length * Step Width * Stride Length * Temporal Parameters * Step Time * Stride Time * Stance Time * Swing Time * Double Support Time We used C-Mill device to evaluate the spatiotemporal parameters.
3 secondary outcomes
Change in Spatial Symmetry
Time frame: 6 weeks after treatment
Change in Temporal Symmetry
Time frame: 6 weeks after treatment
Change in Postural Stability
Time frame: 6 weeks after treatment
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 21 Nov 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot Asisted Gait Training with Lokomat (Endurance), Robot Asisted Gait Training with Lokomat (Attention and Motivation) and Robot Asisted Gait Training with Lokomat (Activity Timing) in people with Stroke, run by Ankara Yildirim Beyazıt 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 4 inclusion and 2 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 21 Nov 2022. 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?
Change in 6 MWT (time frame: 6 weeks after treatment). The study lists 5 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 21 Nov 2022.