StrokeNCT04521829
The Effect of Optic Flow Speed Manipulation and the Level of Immersion on the Gait Pattern in People Post-stroke
A study testing Walking with different optic flow speeds with 2 different VR devices in people with Stroke, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
The aim of this study is to investigate the effect of manipulating the optic flow speed in the virtual environment on the gait pattern during virtual reality (VR) - enhanced treadmill walking in people post-stroke. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Walking with different optic flow speeds with 2 different VR devices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Oct 2020to 23 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosed with stroke (as defined by the World Health Organization)
- stroke onset ≥ 3 months
- ambulatory with an impaired gait pattern (FAC-score 2, 3 or 4)
- ability to walk on a treadmill for 4x8 minutes without bodyweight support
- adult (≥ 18 years)
- ability to signal pain, fear and discomfort
Show all 10Show fewer
- ability to give informed consent
- ≥ 18 years of age
- normal or corrected-to-normal vision with glasses or contact lenses,
- no locomotion impairments
Who cannot join
- other neurological deficits than stroke leading to impaired gait (e.g. Parkinson's disease, multiple sclerosis)
- comorbidities (e.g. COPD, severe osteoporosis, cardiovascular instability)
- visual and/or vestibular disorders that can interfere with the VR
- uncontrolled spasticity significantly interfering with the movement of the lower extremities (Modified Ashworth Scale > 2)
- acute medical illness
- communicative/cognitive problems leading to the inability to understand and carry out instructions
Show all 9Show fewer
- severe unilateral spatial neglect
- having a significant lower extremity injury during the last two years that might affect their gait
- having any type of vestibular/visual deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: WALKING WITH VIRTUAL REALITY: How Does Optic Flow Speed and Level of Immersion Influence the Gait Pattern in People Post-stroke?
The aim of this study is to investigate the effect of manipulating the optic flow speed in the virtual environment on the gait pattern during virtual reality (VR) - enhanced treadmill walking in people post-stroke. Furthermore, the study will also investigate if the level of immersion has an effect on the rehabilitation outcomes by manipulating the optic flow speed in two different VR devices: the semi-immersive GRAIL system and the fully-immersive 'Oculus Rift S' HMD.
To properly understand the results of the people with a stroke, we will also investigate the effect of manipulating the optic flow speed and the level of immersion on the gait pattern in healthy people. That way, we can investigate whether virtual reality has a different influence on the gait pattern of people with a stroke than in healthy people.
Read the detailed description
STUDY DESIGN
This study is an experimental, 2-group, multicenter trial in which people post-stroke and healthy people will perform 2 different sessions of treadmill walking. The 2 sessions will be carried out on 2 separate days within 10 days. Both sessions will be identical, only the VR system used to manipulate the optic flow speed will differ. The order of the 2 sessions and the optic flow speed manipulation will be randomized.
MATERIALS
GRAIL system: The Gait Real-time Interactive Lab (GRAIL) is an integrative motion capture system consisting of 10 optical motion cameras (Vicon Inc., Oxford, UK), a dual belt treadmill with integrated force plates, a 180-degree cylindrical projection screen system, and D-Flow software (Motekforce Link, Amsterdam, Netherlands). The treadmill of the GRAIL system has two modes: fixed walking speed or self-paced. For this study, the treadmill will be self-paced, meaning that the patient is in control and can choose the walking speed. The treadmill will follow the walking speed of the patient, which allow the patient to start, stop and change speed at will. The projection screen of the GRAIL system will assure a semi-immersive virtual environment. The GRAIL system is located in the Smart Space lab (UZ Gent) and will be made available at the researchers of the VUB/UZ Brussel.
Head-mounted display (HMD): The HMD VR system 'Oculus Rift S' (Oculus, LLS, US) is a low-cost HMD that fully integrates the user into the virtual environment by blocking out perception of the real-world. The "Oculus Rift S" will assure a fully immersive virtual environment. The researchers of the VUB/UZ Brussel have the HMD 'Oculus Rift S' in their possession and will make it available for the study.
PROCEDURE
Both sessions will be carried out in the Smart Space lab at the University Hospital of Ghent (Corneel Heymanslaan 10, 9000 Gent) where the GRAIL system is located.
Prior to the start of both sessions, some preparations will have to be done with regard to the outcome measures:
- Patients will be asked to fill in a questionnaire (the Simulator Sickness Questionnaire-Pre).
- Surface electrodes will be placed bilateral on the M. rectus femoris, M. vastus lateralis, M. biceps femoris, M. tibialis anterior, M. gastrocnemius medialis, M. deltoideus anterior part, M. deltoideus posterior part, M. latissimus dorsi. Electrode placement will follow the SENIAM guidelines. The skin underlying the electrode will be shaved and cleaned with alcohol to improve electrode-skin contact and reduce impedance.
- Reflective markers will be placed on fixed points of the lower and upper limbs of the patient. Marker placement will follow the Plug-in Gait full body model (VICON). For this model, the investigator will have to measure the following things in advance: body length, body weight, leg length, knee width, ankle width, shoulder offset, elbow width, wrist width, hand thickness.
After these preparations, patients will start to walk on the self-paced treadmill of the GRAIL system. For safety only, patients will walk with the safety harness. Patients will first be habituated to walking on the self-paced treadmill for 8 minutes without any form of VR. Patients need this habituation trial in order to get used to the self-paced treadmill system. After these 8 minutes, the treadmill will be stopped and patients will be seated for a 5-minute rest period. During the rest period, patients will be asked to fill in two short questionnaires (the Simulator Sickness Questionnaire-1, the VAS scales).
GRAIL session: After the 5-minute rest period, patients will walk for another 3 times 8 minutes with the VR. Patients are now walking while looking at a virtual environment that is projected onto the projection screen of the GRAIL device (semi-immersive). The optic flow will be different during each 8-minute walk. Between each walk, patients will rest for 5 minutes and during each rest period, patients will be asked to fill in a short questionnaire (the Simulator Sickness Questionnaire-2,-3).
HMD session: After the 5-minute rest period, patients will walk for another 3 times 8 minutes with the VR. Patients are now walking while wearing the HMD 'Oculus Rift' and are being fully immersed in a virtual environment (fully-immersive). The optic flow will be different during each 8-minute walk. Between each walk, patients will rest for 5 minutes and during each rest period, patients will be asked to fill in the a short questionnaire (the Simulator Sickness Questionnaire-2,-3).
To end both sessions, participants will be asked to fill in 3 questionnaires (the Simulator Sickness Questionnaire-Post, the VAS scales and the Igroup Presence Questionnaire).
RANDOMIZATION
First, the type of session will be randomized with 2 possible options: GRAIL - HMD or HMD - GRAIL. Second, the optic flow speed manipulation (matched, slow, fast) within the session will be randomized. The order of the manipulation will be the same in both sessions. The first 8 minutes in each session will always be the one without VR. Thereafter, the optic flow speed will be manipulated. There are 6 possible options for the randomization of the optic flow speed manipulation: matched - slow - fast / matched - fast - slow / slow - fast - matched / slow - matched - fast / fast - slow - matched / fast - matched - slow. The randomizations will be done through block randomization in Microsoft Excel®.
STUDY ANALYSIS
This study will investigate (1) the effect of manipulating the optic flow speed and (2) the effect of the level of immersion (semi-immersive GRAIL system with full-immersive HMD).
The effect optic flow speed has on the spatiotemporal gait parameters, kinematics, kinetics and muscle activity will be compared with walking without VR. In a first stage, the data will be visualized using LO(W)ESS smoothing (locally weighted scatterplot smoothing) to explore the observed effects over time (per condition and outcome), allowing for flexibility using this quasi-nonparametric approach. Next, relevant values expressing onset, magnitude and duration of the effect will be extracted:
- Onset: time point(s) at which the minimal clinically important difference (MCID) is exceeded. In case MCID is unknown, a 10% threshold will be used
- Magnitude: magnitude of the maximum (or maxima) and time point(s) at which the maximum is reached
- Duration: time between the onset and the time point at which the MCID (or 10% threshold) is no longer exceeded
These values will be compared between conditions in a two-way repeated measures ANOVA (optic flow speed * device). If relevant (based on the exploratory analyses), additional in-depth statistics, such as functional data analysis, will be performed under the guidance of the Department of Statistics and Data Analysis of our university.
- Conditions
- Stroke
- Being tested
- Walking with different optic flow speeds with 2 different VR devices
- Keywords
- virtual reality, gait, optic flow
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking with different optic flow speeds with 2 different VR devicesOther
Participants will perform 2 sessions of VR-enhanced treadmill walking. One session with the GRAIL system (semi-immersive) and the other session with a fully immersive head-mounted display (Oculus Rift S). In both sessions, the speed of the optic flow will be manipulated: equal to, 2 times faster and 2 times slower than the participant's comfortable walking speed.
| Study group | Role | What they receive |
|---|---|---|
| VR-enhanced treadmill walking | Experimental | Participants will be tested during 2 sessions of VR-enhanced treadmill walking. Receives: Other: Walking with different optic flow speeds with 2 different VR devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D kinematic measurements lower limb
Kinematic data (i.e. movement amplitudes of the bilateral hip, knee and ankle joint in degrees) of the lower limbs during treadmill walking will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Measured: through study completion, an average of 1 year
3D kinematic measurements upper limb (arm swing)
Kinematic data (i.e. movement amplitudes of the bilateral shoulder, elbow and wrist joint in degrees) of the upper limb during treadmill walking will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz. With these data, information about the arm swing during walking will be obtained.
Measured: through study completion, an average of 1 year
3D kinetic measurements lower limb
Kinetic data (i.e. forces, moments and powers of the bilateral hip, knee and ankle joint in respectively Newton, Newton-meters and Watt) of the lower limbs during treadmill walking will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Measured: through study completion, an average of 1 year
Walking speed
Walking speed (m/s) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Measured: through study completion, an average of 1 year
Cadence
Cadence (steps/min) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Measured: through study completion, an average of 1 year
Step length
Step length (cm) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Measured: through study completion, an average of 1 year
Step time
Step time (s) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Measured: through study completion, an average of 1 year
Swing - and stance time
Swing and stance time (s) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Measured: through study completion, an average of 1 year
Single - and double limb support period
Single and double limb support period (% gait cycle) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Measured: through study completion, an average of 1 year
Lower limb muscles activity
Muscle activity of the lower limb muscles (bilateral: M. rectus femoris, M. vastus lateralis, M. biceps femoris, M. tibialis anterior, M. gastrocnemius medialis) will be recorded continuously during treadmill walking with the use of surface electrodes. Signals will be recorded with the wireless EMG system Delsys Tigno (16 channels).
Measured: through study completion, an average of 1 year
Upper limb muscles activity
Muscle activity of the upper limb muscles (bilateral: M. deltoideus anterior part, M. deltoideus posterior part, M. latissimus dorsi) will be recorded continuously during treadmill walking with the use of surface electrodes. Signals will be recorded with the wireless EMG system Delsys Tigno (16 channels).
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Simulator Sickness Questionnaire
The Simulator Sickness Questionnaire (SSQ) is a widely used questionnaire to evaluate motion sickness when using VR. The SSQ consist of 16 symptoms divided in three components: nausea, oculomotor and disorientation. At the beginning of the session and after each 8 minute walk, participants need to indicate how much (none - slight - moderate - severe) each symptom is affecting them at that moment. The total score of the SSQ ranges between 0-235.62 points and higher scores indicate higher levels of simulator sickness.
Measured: through study completion, an average of 1 year
Igroup Presence Questionnaire
The Igroup Presence Questionnaire (IPQ) is a scale for measuring the sense of presence experienced in a virtual environment. The IPQ consists of 14 questions divided in three subscales (spatial presence, involvement, experienced realism) and one additional general item not belonging to a subscale. The IPQ is scored on a 7-point Likert scale. After each session, participants will be asked to fill in the IPQ. The total score of the IPQ ranges between 0-98 points and higher scores indicate a higher sense of presence experienced in a virtual environment.
Measured: through study completion, an average of 1 year
Visual Analogue Scale
After walking without the VR and after walking with the VR, participants will have to fill in two Visual Analogue Scales (VAS). Participants will have to indicate on a 100mm line how much they liked walking on the treadmill under these conditions (VAS1) and whether they would like to do this type of gait training during their rehabilitation (VAS2). The total score of the VAS scales ranges between 0-100 points and higher scores mean a better outcome.
Measured: through study completion, an average of 1 year
Number of falls or stumbles
The number of falls or stumbles that patients experience will be noted in a standardized way.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start10 Oct 2020
- Primary completion23 Jun 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, University Hospital, Ghent
- Responsible party
- Principal investigator, Emma De Keersmaecker, Vrije Universiteit Brussel
- Investigators
- Eva Swinnen, Prof. Ph.D, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521829
- Sponsor's protocol ID
- VR study - GRAIL/HMD
- Status last verified
- Jun 2022
- First submitted
- 3 Aug 2020
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Keersmaecker E, Van Bladel A, Zaccardi S, Lefeber N, Rodriguez-Guerrero C, Kerckhofs E, Jansen B, Swinnen E. Virtual reality-enhanced walking in people post-stroke: effect of optic flow speed and level of immersion on the gait biomechanics. J Neuroeng Rehabil. 2023 Sep 25;20(1):124. doi: 10.1186/s12984-023-01254-0.
PubMed 37749566
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WALKING WITH VIRTUAL REALITY: How Does Optic Flow Speed and Level of Immersion Influence the Gait Pattern in People Post-stroke?
- ClinicalTrials.gov ID
- NCT04521829
- Acronym / sponsor ID
- VR study - GRAIL/HMD
- Conditions
- Stroke
- Keywords
- virtual reality, gait, optic flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- University Ghent, University Hospital, Ghent
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the effect of manipulating the optic flow speed in the virtual environment on the gait pattern during virtual reality (VR) - enhanced treadmill walking in people post-stroke. Furthermore, the study will also investigate if the level of immersion has an effect on the rehabilitation outcomes by manipulating the optic flow speed in two different VR devices: the semi-immersive GRAIL system and the fully-immersive 'Oculus Rift S' HMD.
To properly understand the results of the people with a stroke, we will also investigate the effect of manipulating the optic flow speed and the level of immersion on the gait pattern in healthy people. That way, we can investigate whether virtual reality has a different influence on the gait pattern of people with a stroke than in healthy people.
Detailed description
STUDY DESIGN
This study is an experimental, 2-group, multicenter trial in which people post-stroke and healthy people will perform 2 different sessions of treadmill walking. The 2 sessions will be carried out on 2 separate days within 10 days. Both sessions will be identical, only the VR system used to manipulate the optic flow speed will differ. The order of the 2 sessions and the optic flow speed manipulation will be randomized.
MATERIALS
GRAIL system: The Gait Real-time Interactive Lab (GRAIL) is an integrative motion capture system consisting of 10 optical motion cameras (Vicon Inc., Oxford, UK), a dual belt treadmill with integrated force plates, a 180-degree cylindrical projection screen system, and D-Flow software (Motekforce Link, Amsterdam, Netherlands). The treadmill of the GRAIL system has two modes: fixed walking speed or self-paced. For this study, the treadmill will be self-paced, meaning that the patient is in control and can choose the walking speed. The treadmill will follow the walking speed of the patient, which allow the patient to start, stop and change speed at will. The projection screen of the GRAIL system will assure a semi-immersive virtual environment. The GRAIL system is located in the Smart Space lab (UZ Gent) and will be made available at the researchers of the VUB/UZ Brussel.
Head-mounted display (HMD): The HMD VR system 'Oculus Rift S' (Oculus, LLS, US) is a low-cost HMD that fully integrates the user into the virtual environment by blocking out perception of the real-world. The "Oculus Rift S" will assure a fully immersive virtual environment. The researchers of the VUB/UZ Brussel have the HMD 'Oculus Rift S' in their possession and will make it available for the study.
PROCEDURE
Both sessions will be carried out in the Smart Space lab at the University Hospital of Ghent (Corneel Heymanslaan 10, 9000 Gent) where the GRAIL system is located.
Prior to the start of both sessions, some preparations will have to be done with regard to the outcome measures:
- Patients will be asked to fill in a questionnaire (the Simulator Sickness Questionnaire-Pre).
- Surface electrodes will be placed bilateral on the M. rectus femoris, M. vastus lateralis, M. biceps femoris, M. tibialis anterior, M. gastrocnemius medialis, M. deltoideus anterior part, M. deltoideus posterior part, M. latissimus dorsi. Electrode placement will follow the SENIAM guidelines. The skin underlying the electrode will be shaved and cleaned with alcohol to improve electrode-skin contact and reduce impedance.
- Reflective markers will be placed on fixed points of the lower and upper limbs of the patient. Marker placement will follow the Plug-in Gait full body model (VICON). For this model, the investigator will have to measure the following things in advance: body length, body weight, leg length, knee width, ankle width, shoulder offset, elbow width, wrist width, hand thickness.
After these preparations, patients will start to walk on the self-paced treadmill of the GRAIL system. For safety only, patients will walk with the safety harness. Patients will first be habituated to walking on the self-paced treadmill for 8 minutes without any form of VR. Patients need this habituation trial in order to get used to the self-paced treadmill system. After these 8 minutes, the treadmill will be stopped and patients will be seated for a 5-minute rest period. During the rest period, patients will be asked to fill in two short questionnaires (the Simulator Sickness Questionnaire-1, the VAS scales).
GRAIL session: After the 5-minute rest period, patients will walk for another 3 times 8 minutes with the VR. Patients are now walking while looking at a virtual environment that is projected onto the projection screen of the GRAIL device (semi-immersive). The optic flow will be different during each 8-minute walk. Between each walk, patients will rest for 5 minutes and during each rest period, patients will be asked to fill in a short questionnaire (the Simulator Sickness Questionnaire-2,-3).
HMD session: After the 5-minute rest period, patients will walk for another 3 times 8 minutes with the VR. Patients are now walking while wearing the HMD 'Oculus Rift' and are being fully immersed in a virtual environment (fully-immersive). The optic flow will be different during each 8-minute walk. Between each walk, patients will rest for 5 minutes and during each rest period, patients will be asked to fill in the a short questionnaire (the Simulator Sickness Questionnaire-2,-3).
To end both sessions, participants will be asked to fill in 3 questionnaires (the Simulator Sickness Questionnaire-Post, the VAS scales and the Igroup Presence Questionnaire).
RANDOMIZATION
First, the type of session will be randomized with 2 possible options: GRAIL - HMD or HMD - GRAIL. Second, the optic flow speed manipulation (matched, slow, fast) within the session will be randomized. The order of the manipulation will be the same in both sessions. The first 8 minutes in each session will always be the one without VR. Thereafter, the optic flow speed will be manipulated. There are 6 possible options for the randomization of the optic flow speed manipulation: matched - slow - fast / matched - fast - slow / slow - fast - matched / slow - matched - fast / fast - slow - matched / fast - matched - slow. The randomizations will be done through block randomization in Microsoft Excel®.
STUDY ANALYSIS
This study will investigate (1) the effect of manipulating the optic flow speed and (2) the effect of the level of immersion (semi-immersive GRAIL system with full-immersive HMD).
The effect optic flow speed has on the spatiotemporal gait parameters, kinematics, kinetics and muscle activity will be compared with walking without VR. In a first stage, the data will be visualized using LO(W)ESS smoothing (locally weighted scatterplot smoothing) to explore the observed effects over time (per condition and outcome), allowing for flexibility using this quasi-nonparametric approach. Next, relevant values expressing onset, magnitude and duration of the effect will be extracted:
- Onset: time point(s) at which the minimal clinically important difference (MCID) is exceeded. In case MCID is unknown, a 10% threshold will be used
- Magnitude: magnitude of the maximum (or maxima) and time point(s) at which the maximum is reached
- Duration: time between the onset and the time point at which the MCID (or 10% threshold) is no longer exceeded
These values will be compared between conditions in a two-way repeated measures ANOVA (optic flow speed * device). If relevant (based on the exploratory analyses), additional in-depth statistics, such as functional data analysis, will be performed under the guidance of the Department of Statistics and Data Analysis of our university.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VR-enhanced treadmill walking | Experimental | Other: Walking with different optic flow speeds with 2 different VR devicesParticipants will be tested during 2 sessions of VR-enhanced treadmill walking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- diagnosed with stroke (as defined by the World Health Organization)
- stroke onset ≥ 3 months
- ambulatory with an impaired gait pattern (FAC-score 2, 3 or 4)
- ability to walk on a treadmill for 4x8 minutes without bodyweight support
- adult (≥ 18 years)
Key exclusion criteria (9 listed)
- other neurological deficits than stroke leading to impaired gait (e.g. Parkinson's disease, multiple sclerosis)
- comorbidities (e.g. COPD, severe osteoporosis, cardiovascular instability)
- visual and/or vestibular disorders that can interfere with the VR
- uncontrolled spasticity significantly interfering with the movement of the lower extremities (Modified Ashworth Scale > 2)
- acute medical illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking with different optic flow speeds with 2 different VR devicesParticipants will perform 2 sessions of VR-enhanced treadmill walking. One session with the GRAIL system (semi-immersive) and the other session with a fully immersive head-mounted display (Oculus Rift S). In both sessions, the speed of the optic flow will be manipulated: equal to, 2 times faster and 2 times slower than the participant's comfortable walking speed. | Other | VR-enhanced treadmill walking |
Primary outcome
3D kinematic measurements lower limb
Time frame: through study completion, an average of 1 year
Kinematic data (i.e. movement amplitudes of the bilateral hip, knee and ankle joint in degrees) of the lower limbs during treadmill walking will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
3D kinematic measurements upper limb (arm swing)
Time frame: through study completion, an average of 1 year
Kinematic data (i.e. movement amplitudes of the bilateral shoulder, elbow and wrist joint in degrees) of the upper limb during treadmill walking will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz. With these data, information about the arm swing during walking will be obtained.
3D kinetic measurements lower limb
Time frame: through study completion, an average of 1 year
Kinetic data (i.e. forces, moments and powers of the bilateral hip, knee and ankle joint in respectively Newton, Newton-meters and Watt) of the lower limbs during treadmill walking will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Walking speed
Time frame: through study completion, an average of 1 year
Walking speed (m/s) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Cadence
Time frame: through study completion, an average of 1 year
Cadence (steps/min) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Step length
Time frame: through study completion, an average of 1 year
Step length (cm) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Step time
Time frame: through study completion, an average of 1 year
Step time (s) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Swing - and stance time
Time frame: through study completion, an average of 1 year
Swing and stance time (s) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Single - and double limb support period
Time frame: through study completion, an average of 1 year
Single and double limb support period (% gait cycle) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.
Lower limb muscles activity
Time frame: through study completion, an average of 1 year
Muscle activity of the lower limb muscles (bilateral: M. rectus femoris, M. vastus lateralis, M. biceps femoris, M. tibialis anterior, M. gastrocnemius medialis) will be recorded continuously during treadmill walking with the use of surface electrodes. Signals will be recorded with the wireless EMG system Delsys Tigno (16 channels).
Upper limb muscles activity
Time frame: through study completion, an average of 1 year
Muscle activity of the upper limb muscles (bilateral: M. deltoideus anterior part, M. deltoideus posterior part, M. latissimus dorsi) will be recorded continuously during treadmill walking with the use of surface electrodes. Signals will be recorded with the wireless EMG system Delsys Tigno (16 channels).
4 secondary outcomes
Simulator Sickness Questionnaire
Time frame: through study completion, an average of 1 year
Igroup Presence Questionnaire
Time frame: through study completion, an average of 1 year
Visual Analogue Scale
Time frame: through study completion, an average of 1 year
Number of falls or stumbles
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Derived from this study: PubMed 37749566De Keersmaecker E, Van Bladel A, Zaccardi S, Lefeber N, Rodriguez-Guerrero C, Kerckhofs E, Jansen B, Swinnen E. Virtual reality-enhanced walking in people post-stroke: effect of optic flow speed and level of immersion on the gait biomechanics. J Neuroeng Rehabil. 2023 Sep 25;20(1):124. doi: 10.1186/s12984-023-01254-0.
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RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Swinnen, Prof. Ph.D principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking with different optic flow speeds with 2 different VR devices in people with Stroke, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D kinematic measurements lower limb (time frame: through study completion, an average of 1 year). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04521829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.