Healthy Clinical Trial
Official title:
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 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.
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