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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 26, 2018
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Mukul Mukherjee, University of Nebraska, Omaha

Tracking Information
First Submitted Date  ICMJE December 20, 2018
First Posted Date  ICMJE December 26, 2018
Last Update Posted Date April 28, 2020
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2018)
  • Step-length Symmetry Index [ Time Frame: 1 day ]
    Difference between the length of a step taken by one limb from the other limb
  • Step-time Symmetry Index [ Time Frame: 1 day ]
    Difference between the time of a step taken by one limb from the other limb
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Virtual Reality Augmented Gait Adaptation in Stroke Survivors
Official Title  ICMJE Virtual Reality Augmented Gait Adaptation in Stroke Survivors
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Stroke
Intervention  ICMJE Behavioral: VR - Virtual Reality
Subjects in the experimental group will perform the split-belt task in a VR environment
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: VR - Virtual Reality
  • 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.
    Intervention: Behavioral: VR - Virtual Reality
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 21, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mukul Mukherjee, PhD 402-554-3351 mmukherjee@unomaha.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03787693
Other Study ID Numbers  ICMJE 291-14-EP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mukul Mukherjee, University of Nebraska, Omaha
Study Sponsor  ICMJE University of Nebraska
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mukul Mukherjee, PhD University of Nebraska, Omaha
PRS Account University of Nebraska
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP