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Virtual Reality Augmented Gait Adaptation in Stroke Survivors

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ClinicalTrials.gov Identifier: NCT03787693
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Mukul Mukherjee, University of Nebraska, Omaha

Brief Summary:
The major problem in stroke survivors that is being addressed in this research project is walking asymmetry, i.e., difference between the legs during walking (e.g. steps on the more affected side are longer than the other). A potential solution to this problem is using new technology like virtual reality during walking training to make stroke survivors have a better sense of their asymmetry. A second problem that we aim to address in this study is whether asymmetry is accurately felt by the stroke survivors and how we can address it. Our ongoing work on the effects of virtual reality on learning new walking tasks in stroke survivors indicates that virtual reality maybe particularly important for those with walking asymmetry. In this study, we plan to recruit stroke survivors who have such asymmetries during walking and have them learn a new walking task in virtual reality. We will also test the stroke survivors to determine if there is a relationship between how well they learn the new task with their ability to feel asymmetry accurately.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: VR - Virtual Reality Not Applicable

Detailed Description:
Stroke survivors show a deterioration in bilateral coordination during gait that impacts functional mobility and quality of life. Such deterioration includes spatial (e.g. step length) and temporal (e.g. step time) inter-limb asymmetries during walking (gait asymmetry). While restoration of gait symmetry through adaptive exercise as in split-belt training is an answer, it is compounded by deficits of perception that is common in stroke survivors. One solution to this problem is the use of augmented visual feedback such as virtual reality (VR). Such augmented visual inputs during training can help remove sensory conflicts that commonly exist during gait rehabilitation (e.g. static visual input versus motion perception through proprioceptive input during treadmill walking). The PI's ongoing research investigating the effects of VR on gait adaptation in stroke survivors indicates that the impact of VR is dependent on the subject's baseline gait asymmetry such that the effect of VR is potentially higher in those who have large baseline asymmetries. Therefore, in the current proposal, to determine if this hypothesis is correct, chronic stroke survivors who are above and below a specific asymmetry threshold will be recruited and assessed for the effect of VR on a split-belt treadmill paradigm. In the second aim, the effect of VR on the transfer of split-belt adaptation to a preferred walking trial will be assessed. Since stroke survivors also suffer from major perceptual deficits related to symmetry, in the third aim, the effect of VR on gait adaptation on four groups of stroke survivors will be analyzed those with deficits only in perceiving visual asymmetry, only gait asymmetry, both deficits or neither.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Chronic stroke survivors will be screened and assigned to either a Symmetric or Asymmetric group based on inter-limb step length and/or step time asymmetry at baseline. Each subject will be randomly assigned to perform a split-belt adaptation protocol in either a VR or a Non-VR environment.
Masking: Double (Participant, Investigator)
Masking Description: The PI and the subject will not be aware of the group assignment of each subject.
Primary Purpose: Basic Science
Official Title: Virtual Reality Augmented Gait Adaptation in Stroke Survivors
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
No Intervention: Stroke Symmetric Non-VR
In this control arm, stroke survivors who walk symmetrically will walk on a split-belt treadmill in a non-virtual reality environment.
Experimental: Stroke Symmetric VR
In this experimental arm, stroke survivors who walk symmetrically will walk on a split-belt treadmill in a VR - virtual reality environment.
Behavioral: VR - Virtual Reality
Subjects in the experimental group will perform the split-belt task in a VR environment

No Intervention: Stroke Asymmetric Non-VR
In this control arm, stroke survivors who walk asymmetrically will walk on a split-belt treadmill in a non-virtual reality environment.
Experimental: Stroke Asymmetric VR
In this experimental arm, stroke survivors who walk asymmetrically will walk on a split-belt treadmill in a VR - virtual reality environment.
Behavioral: VR - Virtual Reality
Subjects in the experimental group will perform the split-belt task in a VR environment




Primary Outcome Measures :
  1. Step-length Symmetry Index [ Time Frame: 1 day ]
    Difference between the length of a step taken by one limb from the other limb

  2. Step-time Symmetry Index [ Time Frame: 1 day ]
    Difference between the time of a step taken by one limb from the other limb



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adults > 21 years
  • diagnosed with supratentorial ischemic or hemorrhagic stroke
  • single, unilateral stroke
  • stroke incident > 3 months duration.
  • ability to stand unsupported without an assistive device
  • walk 10m without therapist assistance,
  • ability to follow instructions (Folstein Mini-Mental exam score ≥ 24)

Exclusion Criteria:

  • recurrent stroke
  • hip fracture
  • myocardial infarction
  • < 20/40 corrected vision
  • any condition that can affect walking ability to complete the experiment successfully (e.g. neglect, Parkinson's disease, vestibulopathy, peripheral nerve pathology).

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): NCT03787693


Contacts
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Contact: Mukul Mukherjee, PhD 402-554-3351 mmukherjee@unomaha.edu

Locations
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United States, Nebraska
Biomechanics Research Building Recruiting
Omaha, Nebraska, United States, 68182
Sponsors and Collaborators
University of Nebraska
Investigators
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Principal Investigator: Mukul Mukherjee, PhD University of Nebraska, Omaha

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Responsible Party: Mukul Mukherjee, Associate Professor, University of Nebraska, Omaha
ClinicalTrials.gov Identifier: NCT03787693     History of Changes
Other Study ID Numbers: 291-14-EP
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018

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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 Mukul Mukherjee, University of Nebraska, Omaha:
hemiparesis
gait
perception
sensory
vision
coordination

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases