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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Robot Asisted Gait Training with Lokomat (Endurance); Other: Conventional Physiotherapy; Other: Robot Asisted Gait Training with Lokomat (Attention and Motivation); Other: Robot Asisted Gait Training with Lokomat (Activity Timing)

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06000
    • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lokomat Group I (Endurance); Faster application used with Lokomat gait training; Conventional Physiotherapy	Other: 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: Conventional Physiotherapy; -Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
Experimental: Lokomat Group II (Attention and Motivation); Smile and Gabarello applications used with Lokomat gait training; Conventional Physiotherapy	Other: Conventional Physiotherapy; -Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.; 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.
Experimental: Lokomat Group III (Activity Timing); High Flyer, Curve Pursuit and Treasures applications used with Lokomat gait training; Conventional Physiotherapy	Other: Conventional Physiotherapy; -Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.; 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.
Other: Control; -Only Conventional Physiotherapy	Other: Conventional Physiotherapy; -Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	6 weeks after treatment
Change in Spatiotemporal Gait Analysis	Spatiotemporal gait analysis gives spatial (distance) parameters along with temporal (time) parameters.; Spatial parameters:Step LengthStep WidthStride Length; Temporal ParametersStep TimeStride TimeStance TimeSwing TimeDouble Support Time We used C-Mill device to evaluate the spatiotemporal parameters.	6 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Spatial Symmetry	It is the ratio of the hemiplegic side step lenght to the non-hemiplegic side step lenght.	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.	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.	6 weeks after treatment

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University
• Collaborators: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 11, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Virtual Reality; Augmented performance feedback; Lokomat
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Lokomat VR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No