Clinical trial NCT05419791: The Effects of Lokomat Virtual Reality Applications on Balance and Gait in Stroke Patients
Official title: The Effects of Lokomat Virtual Reality Applications on Balance and Gait in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Augmented performance feedback
Lokomat
Stroke
Rehabilitation
Virtual Reality
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
Collaborators: name: Ankara City Hospital Bilkent
First posted: 2022-06-15
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individuals have been assigned to groups by Research Randomizer program.
Primary purpose: TREATMENT

Brief 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. 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+.

Eligibility criteria: * Inclusion Criteria:

  * 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
* Exclusion Criteria:

  * Any condition that may prevent walking with Lokomat
  * Not volunteering to participate in the study

Primary outcomes:
measure: Change in 6 MWT
timeFrame: 6 weeks after treatment
measure: Change in 10 MWT
timeFrame: 6 weeks after treatment
measure: Change in BBS
timeFrame: 6 weeks after treatment
measure: Change in Limits of Stability
timeFrame: 6 weeks after treatment
measure: Change in Spatiotemporal Gait Analysis
timeFrame: 6 weeks after treatment
Secondary outcomes:
measure: Change in Spatial Symmetry
timeFrame: 6 weeks after treatment
measure: Change in Temporal Symmetry
timeFrame: 6 weeks after treatment
measure: Change in Postural Stability
timeFrame: 6 weeks after treatment
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
References: