Stroke Clinical Trial
Official title:
The Effects of Overground Visual Biofeedback on Walking Speed and Symmetry in Individuals Post-stroke
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 | Recruiting |
Enrollment | 38 |
Est. completion date | December 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Age 19-80 years 2. Chronic stroke (>6 months post-stroke) 3. Be able to walk 10-meters with or without an assistive device 4. Sufficient cognitive ability to understand instructions and communicate with the study team (moderate or better score on MOCA/MMSE) Exclusion Criteria: 1. Multiple strokes 2. Complaints of cardiorespiratory or musculoskeletal disorders that would affect walking 3. Visual deficits or hemi-neglect 4. Other neurologic disorders beyond stroke |
Country | Name | City | State |
---|---|---|---|
United States | University of Nebraska at Omaha | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Walking Speed | Walking speed as measured by motion capture | change in walking speed from pre-training, immediately after completing the training (post-training), and 24-hour follow-up | |
Secondary | Peak Hip Extension | Peak hip extension as measured by motion capture | change in peak hip extension and inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up | |
Secondary | Peak Propulsive Force | Peak propulsion as measured by motion capture | change in peak propulsive force and inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up | |
Secondary | Step width | Step width as measured by motion capture | change in inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up | |
Secondary | Step length | Step length as measured by motion capture | change in inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up | |
Secondary | Step time | step time as measured by motion capture | change in inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up |
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