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Virtual Reality Augmented Gait Adaptation in Stroke Survivors

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VR - Virtual Reality
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke focused on measuring hemiparesis, gait, perception, sensory, vision, coordination

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • University of Nebraska - Omaha, Biomechanics Research BuildingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

No Intervention

Experimental

Arm Label

Stroke Symmetric Non-VR

Stroke Symmetric VR

Stroke Asymmetric Non-VR

Stroke Asymmetric VR

Arm Description

In this control arm, stroke survivors who walk symmetrically will walk on a split-belt treadmill in a non-virtual reality environment.

In this experimental arm, stroke survivors who walk symmetrically will walk on a split-belt treadmill in a VR - virtual reality environment.

In this control arm, stroke survivors who walk asymmetrically will walk on a split-belt treadmill in a non-virtual reality environment.

In this experimental arm, stroke survivors who walk asymmetrically will walk on a split-belt treadmill in a VR - virtual reality environment.

Outcomes

Primary Outcome Measures

Step-length Symmetry Index
Difference between the length of a step taken by one limb from the other limb
Step-time Symmetry Index
Difference between the time of a step taken by one limb from the other limb

Secondary Outcome Measures

Full Information

First Posted
December 20, 2018
Last Updated
October 18, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT03787693
Brief Title
Virtual Reality Augmented Gait Adaptation in Stroke Survivors
Official Title
Virtual Reality Augmented Gait Adaptation in Stroke Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
hemiparesis, gait, perception, sensory, vision, coordination

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
The PI and the subject will not be aware of the group assignment of each subject.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stroke Symmetric Non-VR
Arm Type
No Intervention
Arm Description
In this control arm, stroke survivors who walk symmetrically will walk on a split-belt treadmill in a non-virtual reality environment.
Arm Title
Stroke Symmetric VR
Arm Type
Experimental
Arm Description
In this experimental arm, stroke survivors who walk symmetrically will walk on a split-belt treadmill in a VR - virtual reality environment.
Arm Title
Stroke Asymmetric Non-VR
Arm Type
No Intervention
Arm Description
In this control arm, stroke survivors who walk asymmetrically will walk on a split-belt treadmill in a non-virtual reality environment.
Arm Title
Stroke Asymmetric VR
Arm Type
Experimental
Arm Description
In this experimental arm, stroke survivors who walk asymmetrically will walk on a split-belt treadmill in a VR - virtual reality environment.
Intervention Type
Behavioral
Intervention Name(s)
VR - Virtual Reality
Intervention Description
Subjects in the experimental group will perform the split-belt task in a VR environment
Primary Outcome Measure Information:
Title
Step-length Symmetry Index
Description
Difference between the length of a step taken by one limb from the other limb
Time Frame
1 day
Title
Step-time Symmetry Index
Description
Difference between the time of a step taken by one limb from the other limb
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mukul Mukherjee, PhD
Phone
402-554-3351
Email
mmukherjee@unomaha.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mukul Mukherjee, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska - Omaha, Biomechanics Research Building
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68182
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mukul Mukherjee, PhD
Phone
402-554-3351
Email
mmukherjee@unomaha.edu

12. IPD Sharing Statement

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Virtual Reality Augmented Gait Adaptation in Stroke Survivors

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