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The Effect of Optic Flow During Treadmill Walking on the Gait Pattern in People Post-stroke

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ClinicalTrials.gov Identifier: NCT03898375
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Emma De Keersmaecker, Vrije Universiteit Brussel

Brief Summary:
The aim of this study is to investigate the onset, magnitude and duration of the effect of manipulating the optic flow on the gait pattern during Virtual Reality (VR)-enhanced treadmill walking compared to treadmill walking without VR in people post-stroke.

Condition or disease Intervention/treatment Phase
Stroke Other: Walking with different optic flow speeds Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: VR-enhanced Walking in People Post-stroke: the Effect of Changing the Optic Flow Speed During Treadmill Walking on the Gait Pattern
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: VR-enhanced treadmill walking
Participants will be tested during 4 sessions of 20 minutes treadmill walking.
Other: Walking with different optic flow speeds
Patients will perform 4 sessions of 20 minutes treadmill walking: one control session without VR and 3 walking sessions with the VR. In each VR session, patients will walk with a different optic flow speed: the same as, faster than or slower than their walking speed.




Primary Outcome Measures :
  1. 3D kinematic measurements [ Time Frame: Kinematic data will be measured continuously for 20 minutes and will be expressed per gait cycle ]
    Kinematic data of the lower limbs (i.e. movement amplitudes of the bilateral hip, knee and ankle joint) during treadmill walking will be recorder continuously.

  2. Spatiotemporal gait parameters [ Time Frame: Spatiotemporal gait parameters will be measured continuously for 20 minutes and will be expressed per gait cycle ]
    Spatiotemporal gait parameters of the lower limbs (i.e. walking speed, cadence, step length and - time, swing - and stance time, single - and double limb support period) during treadmill walking will be recorded continuously.

  3. Muscle activity (EMG) [ Time Frame: Muscle activity will be measured continuously for 20 minutes and will be expressed per gait cycle ]
    Muscle activity of the lower limb muscles (bilateral: M. rectus femoris, M. vastus medialis and lateralis, M. biceps femoris, M. tibialis anterior, M. gastrocnemius medialis and lateralis) will be recorded continuously during treadmill walking with the use of surface electrodes.


Secondary Outcome Measures :
  1. Simulator Sickness Questionnaire (SSQ) [ Time Frame: The SSQ will be assessed twice per session (session 1 - 2 - 3 - 4): immediately before and after the participants walked for 20 minutes. ]
    The SSQ is a widely used questionnaire to evaluate motion sickness when using VR and consist of 16 symptoms. The SSQ will be assessed twice per walking session: at the beginning and at the end of each walking session. Patients need to indicate on a 4 point likert scale how much (none = 0 / slight = 1 / moderate = 2 / severe = 3) each symptom is affecting them at that moment. The SSQ has a minimum score of 0 and a maximum score of 48. Higher scores represent a worse outcome (more side effects due to the VR).

  2. Physical Activity Enjoyment Scale (PACES) [ Time Frame: The PACES will be assessed once per session (session 1 - 2 - 3 - 4): immediately after the participants walked for 20 minutes. ]
    The PACES is an 18-item scale assessing enjoyment by asking participants to rate (on a scale of 1 to 7) how they felt about the physical activity they have been doing. The PACES has a minimum score of 18 points and a maximum score is 126. Higher scores represent a better outcome (they liked the activity more).

  3. Number of falls or stumbles [ Time Frame: The number of falls or stumbles will be assessed continuously for 20 minutes when patients are walking on the treadmill. The number of falls will be collected for each walking session (session 1 - 2 - 3 - 4). ]
    The number of falls or stumbles that patients experience will be noted in a standardized way.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed with stroke (as defined by the World Health Organization)
  • stroke onset ≥ 6 months
  • ambulatory with an impaired gait pattern (FAC-score 2 or 3 or 4)
  • ability to walk on a treadmill for 20 minutes without bodyweight support
  • adult (≥ 18 years)
  • a body height between 155 cm and 200 cm
  • ability to signal pain, fear and discomfort
  • ability to give informed consent

Exclusion Criteria:

  • other neurological deficits than stroke leading to impaired gait
  • comorbidities (e.g. COPD, 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
  • severe unilateral spatial neglect

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898375


Contacts
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Contact: Emma De Keersmaecker 003224774529 ext 003224775584 emma.de.keersmaecker@vub.be
Contact: Eva Swinnen, Prof. Ph.D 003224774529 ext 003224774529 eva.swinnen@vub.be

Locations
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Belgium
Vrije Universiteit Brussel Recruiting
Brussel, Belgium, 1050
Sponsors and Collaborators
Vrije Universiteit Brussel
Investigators
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Principal Investigator: Eva Swinnen, Prof. Ph.D Vrije Universiteit Brussel
Study Chair: Eric Kerckhofs, Prof. Ph.D Vrije Universiteit Brussel

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Responsible Party: Emma De Keersmaecker, Doctoral Researcher, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT03898375     History of Changes
Other Study ID Numbers: VR study I - optic flow
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emma De Keersmaecker, Vrije Universiteit Brussel:
Virtual reality
optic flow
gait
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors