search
Back to results

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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
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
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Augmented performance feedback, Lokomat, Stroke, Rehabilitation, Virtual Reality

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers
  • 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

Sites / Locations

  • Ankara City Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

Lokomat Group I (Endurance)

Lokomat Group II (Attention and Motivation)

Lokomat Group III (Activity Timing)

Control

Arm Description

Faster application used with Lokomat gait training Conventional Physiotherapy

Smile and Gabarello applications used with Lokomat gait training Conventional Physiotherapy

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

-Only Conventional Physiotherapy

Outcomes

Primary Outcome Measures

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.
Change in 10 MWT
10 MWT is a test using for evaluate the gait speed. Gait speed is a spatiotemporal parameter.
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.
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.
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.

Secondary Outcome Measures

Change in Spatial Symmetry
It is the ratio of the hemiplegic side step lenght to the non-hemiplegic side step lenght.
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.
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.

Full Information

First Posted
June 8, 2022
Last Updated
November 16, 2022
Sponsor
Ankara Yildirim Beyazıt University
Collaborators
Ankara City Hospital Bilkent
search

1. Study Identification

Unique Protocol Identification Number
NCT05419791
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Yildirim Beyazıt University
Collaborators
Ankara City Hospital Bilkent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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+.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Augmented performance feedback, Lokomat, Stroke, Rehabilitation, Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Individuals have been assigned to groups by Research Randomizer program.
Masking
Outcomes Assessor
Masking Description
The assessor has been masked.
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lokomat Group I (Endurance)
Arm Type
Experimental
Arm Description
Faster application used with Lokomat gait training Conventional Physiotherapy
Arm Title
Lokomat Group II (Attention and Motivation)
Arm Type
Experimental
Arm Description
Smile and Gabarello applications used with Lokomat gait training Conventional Physiotherapy
Arm Title
Lokomat Group III (Activity Timing)
Arm Type
Experimental
Arm Description
High Flyer, Curve Pursuit and Treasures applications used with Lokomat gait training Conventional Physiotherapy
Arm Title
Control
Arm Type
Other
Arm Description
-Only Conventional Physiotherapy
Intervention Type
Other
Intervention Name(s)
Robot Asisted Gait Training with Lokomat (Endurance)
Intervention Description
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
Intervention Name(s)
Robot Asisted Gait Training with Lokomat (Attention and Motivation)
Intervention Description
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
Intervention Name(s)
Robot Asisted Gait Training with Lokomat (Activity Timing)
Intervention Description
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
Intervention Name(s)
Conventional Physiotherapy
Intervention Description
-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
Primary Outcome Measure Information:
Title
Change in 6 MWT
Description
6 Minutes Walk Test is a test using for walking distance. We evaluated the change in walking distance with 6 MWT.
Time Frame
6 weeks after treatment
Title
Change in 10 MWT
Description
10 MWT is a test using for evaluate the gait speed. Gait speed is a spatiotemporal parameter.
Time Frame
6 weeks after treatment
Title
Change in BBS
Description
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.
Time Frame
6 weeks after treatment
Title
Change in Limits of Stability
Description
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.
Time Frame
6 weeks after treatment
Title
Change in Spatiotemporal Gait Analysis
Description
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.
Time Frame
6 weeks after treatment
Secondary Outcome Measure Information:
Title
Change in Spatial Symmetry
Description
It is the ratio of the hemiplegic side step lenght to the non-hemiplegic side step lenght.
Time Frame
6 weeks after treatment
Title
Change in Temporal Symmetry
Description
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.
Time Frame
6 weeks after treatment
Title
Change in Postural Stability
Description
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.
Time Frame
6 weeks after treatment

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only men
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Ankara City Hospital
City
Ankara
ZIP/Postal Code
06000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs