NCT03787693

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

7.5 years

First QC Date

December 20, 2018

Last Update Submit

April 14, 2026

Conditions

Keywords

hemiparesisgaitperceptionsensoryvisioncoordination

Outcome Measures

Primary Outcomes (2)

  • Step-length Symmetry Index

    Difference between the length of a step taken by one limb from the other limb

    1 day

  • Step-time Symmetry Index

    Difference between the time of a step taken by one limb from the other limb

    1 day

Study Arms (4)

Stroke Symmetric Non-VR

NO INTERVENTION

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

Stroke Symmetric VR

EXPERIMENTAL

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

Stroke Asymmetric Non-VR

NO INTERVENTION

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

Stroke Asymmetric VR

EXPERIMENTAL

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

Interventions

Subjects in the experimental group will perform the split-belt task in a VR environment

Stroke Asymmetric VRStroke Symmetric VR

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska - Omaha, Biomechanics Research Building

Omaha, Nebraska, 68182, United States

Location

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mukul Mukherjee, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The PI and the subject will not be aware of the group assignment of each subject.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2018

First Posted

December 26, 2018

Study Start

July 1, 2018

Primary Completion

December 15, 2025

Study Completion

December 15, 2025

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations