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NCT05420857Completed

Effects of Biofeedback on Walking Speed Post-stroke

The Effects of Overground Visual Biofeedback on Walking Speed and Symmetry in Individuals Post-stroke

Source: ClinicalTrials.gov · Last updated 18 Oct 2024

Brief summary (registry, in English)

Stroke is the leading cause of serious long-term disability in the United States. Walking speed is related to stroke severity and how well someone can return to community life. Biofeedback is a useful method for increasing walking speed in persons post-stroke, however, these methods are typically limited to laboratory settings. The objective of this research is to determine the short-term response and training potential of a novel, wearable device that provides visual feedback of hip extension during unconstrained over ground walking. The aims of this study are to 1) determine short-term effects of visual biofeedback on biomechanical outcomes, 2) determine the short-term effects of visual biofeedback on gait symmetry during overground walking in individuals post-stroke. The investigators hypothesize that biomechanical and spatiotemporal outcomes will improve following training with the wearable biofeedback device. To assess these aims, participants' gait biomechanics will be assessed pre- and post-training with the biofeedback device as well as 24-hours following the training. Walking speed (primary outcome) as well as hip extension angle, propulsive force, step width, step length, and step time will be assessed to determine changes in performance with use of the device. By understanding short-term responses to this novel training paradigm, research can begin assessing the potential of wearable biofeedback devices in improving gait in persons post-stroke. Should this training prove successful, this study will provide the necessary feasibility data to motivate a larger scale, case-control clinical trial to determine efficacy of the device and training.

Status (registry)
Completed
Study type
Interventional
Enrollment
15 (actual)
First submitted
7 Jun 2022
Start date
1 Jan 2023
Primary completion date
16 Oct 2024
Lead sponsor
University of Nebraska
Diseases
Stroke
NCT number
NCT05420857

What you commit to

  • Study type: Interventional
  • Participants enrolled: 15
  • From 1 Jan 2023 to the primary completion date, 16 Oct 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Complaints of cardiorespiratory or musculoskeletal disorders that would affect walking
  • Other neurologic disorders beyond stroke

Other

  • Multiple strokes
  • Visual deficits or hemi-neglect

Who the study is looking for

  • Age 19-80 years
  • Chronic stroke (\>6 months post-stroke)
  • Be able to walk 10-meters with or without an assistive device
  • Sufficient cognitive ability to understand instructions and communicate with the study team: moderate or better score on Montreal Cognitive Assessment (MOCA)/Mini-mental State Examination (MMSE)

Age in the registry: 19 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Nebraska at Omaha
Coordinator of this site? Confirm its status
OmahaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.