Immersive Virtual Reality During Robot-assisted Walking.

April 23, 2019 updated by: Emma De Keersmaecker, Vrije Universiteit Brussel

The Use of Immersive Virtual Reality During Robot-assisted Walking in Healthy Adults - Effect of Changing the Optic Flow Speed in Two Different Virtual Environments on Active Participation During Robot-assisted Walking.

The aim of this study is to investigate the effect of manipulating the optic flow (OF) speed in 2 different virtual environments (VE) on active participation in healthy participants during virtual reality (VR) - enhanced robot-assisted gait(RAG).

The second aim is to investigate the effect of two different VEs on active participation during RAG.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

STUDY DESIGN: an experimental, 2-group, single-center trial will be conducted in which healthy participants will perform one VR-enhanced RAG session in which 3 different OF speeds will be presented in a random order: 1) walking with slow OF speed, 2) walking with matched OF speed, and 3) walking with fast OF speed. The VE will be different for both groups. The experimental group will have a stimulus rich VE that represents a park where subjects will walk through. This VE will be more interactive by allowing other avatars or animals to walk through the VE. The control group will have a stimulus poor VE that represents an endless hallway. Since the subjects will walk alone in the hallway for the entire time, this VE will be less interactive.

PATIENT RECRUITMENT: we aim to recruit 28 healthy participants, divided equally into two groups. In case subjects drop out, additional participants will be tested till 14 participants in each group completed all conditions.

PROCEDURE: Participants will be tested during one VR-enhanced RAG session at the rehabilitation center TrainM (Antwerp). Prior to the start of the experiment, surface electrodes will be placed bilateral on the Mm. rectus femoris and Mm. biceps femoris to measure muscle activity. Electrode placement will follow as closely as possible the guidelines of SENIAM. The skin underlying the electrode will be shaved and cleaned to improve electrode-skin contact and reduce impedance. At the start of the session, participants will be habituated to walking in the Lokomat without the VR. During this habituation trial, the appropriate settings to walk comfortable in the exoskeleton will be determined. To make sure all participants will walk comfortable in the Lokomat, subjects will be provided with a body weight support (BWS) of 30%. Guidance Force (GF) will be set on 80% for all participants. With lower levels of GF, the biofeedback values will show smaller changes and can become negligible. Lastly, the walking speed (WS) will be set at 2.8 km/h for all participants. Preparing and installing the participant and determining the appropriate Lokomat settings will take no longer than 20 minutes. When the Lokomat settings are defined, the Lokomat will be stopped for a moment so that the VR can be added. Participants will put on the head-mounted display (HMD) and will start walking again for one minute while watching the VE scene expanding at a speed matching their walking speed to get used to the VR. After the habituation trial, participants will walk in the Lokomat with the three different OF speeds that will be presented in a random order for 7 minutes each:

  1. slower OF: 0.5 times the individual's WS,
  2. matched OF: same as the individual's WS,
  3. faster OF: 2 times the individual's WS.

In order to normalize the registered EMG signals, the maximum voluntary isometric contraction (MVIC) test will be used. Each subject carries out the MVIC test 3 times for each muscle. Subjects must reach their maximum strength as quickly as possible and must keep it for 6 seconds. Subjects will perform the MVIC test in the following testing positions: prone with the knees in 30° of flexion (Mm. biceps femoris); seated with the knees in 60°of flexion, and the hips in 90° of flexion (Mm. rectus femoris). The average of the three tests will be taken for each muscle.

RANDOMIZATION: Subjects who agree to participate in this study will be equally randomized in a 1:1 ratio into 2 groups. For randomization, sealed envelopes will be prepared in advance and marked on the inside with a VE + or VE -. During the intervention, the speed of the OF (slow, matched or fast) will also be randomized. To participants, it will only be said that they will have to walk in the Lokomat with the VR for 21 minutes. They will not know that and when the speed of the OF will change.

MATERIALS: The VR will be provided with the use of a novel HMD VR system 'Oculus Rift' (Oculus Rift, LLC, US). The Oculus Rift promises the user more immersion and visual clarity of the virtual rendered world, by use of a custom display and optics technology designed specifically for VR.

Surface EMG electrodes will be used to measure the muscle activity of the Mm. rectus femoris and Mm. biceps femoris. Surface EMG data will be captured with the ME6000 EMG-system (Mega Electronics Ltd) using Conmed Cleartrace electrodes (Ag/AgCl) with an active diameter of 10mm.

The Lokomat has a biofeedback system that measures and displays participants' activity in real-time. With the use of force sensors, this biofeedback system measures the torques acting onto the corresponding Lokomat joint. This is calculated from the signals of the force sensors in the drives. Positive values correspond to external forces (from the subject) acting into flexion direction, while negative values correspond to external forces (from the subject) acting into extension. Besides force sensors, the Lokomat also comprises position sensors. These sensors will be used to measure the range of motion (ROM) of the hip- and knee joints. A value of 0 corresponds to a neutral position, positive values corresponds to flexion and negative values to extension.

STATISTICAL ANALYSIS: Statistics will be performed using SPSS (IBM, Chicago, IL). The significance level will be set on 5%. Descriptive statistics will be calculated for baseline participant characteristics. Means and standard deviations will be calculated for continues variables and frequencies and percentages for categorical variables. Active participation will be determined with the use of muscle activity (EMG), interaction torques and range of motion and will be measured continuously during the session. Data analysis of the average of every minute will be conducted. To investigate the effect of time, the different OF speeds, and the different VEs, repeated-measures ANOVA (within-between subject design) will be analyzed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2018
        • Rehabilitation center TrainM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy persons ≥ 55 years of age,
  2. Normal or corrected-to-normal vision with glasses or contact lenses,
  3. No locomotion impairments,
  4. A maximal body weight of 135 kg,
  5. A maximal body height of 200 cm

Exclusion Criteria:

  1. Skin lesions that cannot be protected appropriately,
  2. Significant lower extremity injuries during the last two years that might affect their gait,
  3. Any type of vestibular/visual deficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Stimulus rich VE
Participants will be tested during 1 RAG session in the Lokomat. Participants in the experimental group will walk in a stimulus rich VE such as walking in a park.
Other: Stimulus rich VE
Participants will walk in the Lokomat with the VR for 21 minutes. After every 7 minutes, the speed of the OF will change (2 times the comfortable walking speed, equally to the comfortable walking speed, and 0.5 times the comfortable walking speed).
Active Comparator: Stimulus poor VE
Participants will be tested during 1 RAG session in the Lokomat. Participants in the control group will walk in a stimulus poor VE, such as walking through an endless hallway.
Other: Stimulus poor VE
Participants will walk in the Lokomat with the VR for 21 minutes. After every 7 minutes, the speed of the OF will change (2 times the comfortable walking speed, equally to the comfortable walking speed, and 0.5 times the comfortable walking speed).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Muscle activity (EMG)
Time Frame: Every minute of the 21-minute session.
Muscle activity will be measured continuously during the 21 minutes of testing. Average muscle activity (%MVIC) will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.
Every minute of the 21-minute session.
Interaction torques left hip
Time Frame: Every minute of the 21-minute session.
Interaction torques will be measured continuously during the 21 minutes of testing. Average interaction torques (Nm) between participant and device will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.
Every minute of the 21-minute session.
Interaction torques left knee
Time Frame: Every minute of the 21-minute session.
Interaction torques will be measured continuously during the 21 minutes of testing. Average interaction torques (Nm) between participant and device will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.
Every minute of the 21-minute session.
Interaction torques right hip
Time Frame: Every minute of the 21-minute session.
Interaction torques will be measured continuously during the 21 minutes of testing. Average interaction torques (Nm) between participant and device will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.
Every minute of the 21-minute session.
Interaction torques right knee
Time Frame: Every minute of the 21-minute session.
Interaction torques will be measured continuously during the 21 minutes of testing. Average interaction torques (Nm) between participant and device will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.
Every minute of the 21-minute session.
Range of motion left hip
Time Frame: Every minute of the 21-minute session.
Range of motion will be measured continuously during the 21 minutes of testing. Average range of motion (°) will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.
Every minute of the 21-minute session.
Range of motion left knee
Time Frame: Every minute of the 21-minute session.
Range of motion will be measured continuously during the 21 minutes of testing. Average range of motion (°) will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.
Every minute of the 21-minute session.
Range of motion right hip
Time Frame: Every minute of the 21-minute session.
Range of motion will be measured continuously during the 21 minutes of testing. Average range of motion (°) will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.
Every minute of the 21-minute session.
Range of motion right knee
Time Frame: Every minute of the 21-minute session.
Range of motion will be measured continuously during the 21 minutes of testing. Average range of motion (°) will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.
Every minute of the 21-minute session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vrije Universiteit Brussel

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emma De Keersmaecker, Ph.D student, Vrije Universiteit Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 13, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 13, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Lokomat study with VR - I

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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