The Effects of Lokomat Virtual Reality Applications on Balance and Gait in Stroke Patients

NCT ID: NCT05419791

Last Updated: 2022-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2022-06-01

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+.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lokomat Group I (Endurance)

• Faster application used with Lokomat gait training
• Conventional Physiotherapy

Group Type: EXPERIMENTAL

Robot Asisted Gait Training with Lokomat (Endurance)

Intervention Type: 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.

Conventional Physiotherapy

Intervention Type: OTHER

-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.

Lokomat Group II (Attention and Motivation)

• Smile and Gabarello applications used with Lokomat gait training
• Conventional Physiotherapy

Group Type: EXPERIMENTAL

Robot Asisted Gait Training with Lokomat (Attention and Motivation)

Intervention Type: 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.

Conventional Physiotherapy

Intervention Type: OTHER

-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.

Lokomat Group III (Activity Timing)

• High Flyer, Curve Pursuit and Treasures applications used with Lokomat gait training
• Conventional Physiotherapy

Group Type: EXPERIMENTAL

Robot Asisted Gait Training with Lokomat (Activity Timing)

Intervention Type: 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 Physiotherapy

Intervention Type: OTHER

-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.

Control

-Only Conventional Physiotherapy

Group Type: OTHER

Conventional Physiotherapy

Intervention Type: OTHER

-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Conventional Physiotherapy

-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: collaborator

Ankara Yildirim Beyazıt University

OTHER

Sponsor Role: lead

Responsible Party

Murat Akıncı

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Lokomat VR

Identifier Type: -

Identifier Source: org_study_id