- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03787693
Virtual Reality Augmented Gait Adaptation in Stroke Survivors
April 14, 2026 updated by: University of Nebraska
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.
Study Overview
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
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nebraska
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Omaha, Nebraska, United States, 68182
- University of Nebraska - Omaha, Biomechanics Research Building
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
Subjects in the experimental group will perform the split-belt task in a VR environment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Step-length Symmetry Index
Time Frame: 1 day
|
Difference between the length of a step taken by one limb from the other limb
|
1 day
|
|
Step-time Symmetry Index
Time Frame: 1 day
|
Difference between the time of a step taken by one limb from the other limb
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mukul Mukherjee, PhD, University of Nebraska
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2018
Primary Completion (Actual)
December 15, 2025
Study Completion (Actual)
December 15, 2025
Study Registration Dates
First Submitted
December 20, 2018
First Submitted That Met QC Criteria
December 21, 2018
First Posted (Actual)
December 26, 2018
Study Record Updates
Last Update Posted (Actual)
April 16, 2026
Last Update Submitted That Met QC Criteria
April 14, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0291-14-EP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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