Overground Visual Biofeedack for Stroke

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Nebraska at Omaha, Omaha, NE
Stroke
Overground Visual Biofeedack - Other
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

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.

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: change in walking speed from pre-training, immediately after completing the training (post-training), and 24-hour follow-up

change in inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up
Step length
Step time
Step width
change in peak hip extension and inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up
Peak Hip Extension
change in peak propulsive force and inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up
Peak Propulsive Force
change in walking speed from pre-training, immediately after completing the training (post-training), and 24-hour follow-up
Walking Speed

Trial Safety

Trial Design

1 Treatment Group

Hip Biofeedback
1 of 1
Experimental Treatment

38 Total Participants · 1 Treatment Group

Primary Treatment: Overground Visual Biofeedack · No Placebo Group · N/A

Hip Biofeedback
Other
Experimental Group · 1 Intervention: Overground Visual Biofeedack · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change in walking speed from pre-training, immediately after completing the training (post-training), and 24-hour follow-up
Closest Location: University of Nebraska at Omaha · Omaha, NE
Photo of Omaha 1Photo of Omaha 2Photo of Omaha 3
2018First Recorded Clinical Trial
1 TrialsResearching Stroke
5 CompletedClinical Trials

Who is running the clinical trial?

University of NebraskaLead Sponsor
475 Previous Clinical Trials
1,135,466 Total Patients Enrolled
2 Trials studying Stroke
309 Patients Enrolled for Stroke

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to walk 10-meters without an assistive device.
You have sufficient cognitive ability to understand instructions and communicate with the study team.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.