Effects of Biofeedback on Walking Speed Post-stroke

NCT05420857 | Completed

• 1 other identifier: 0902-19-EP
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Peak Hip Extension

  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 Propulsive Force

  change in peak propulsive force and inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up

• Step width

  change in inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up

• Step length

  change in inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up

• Step time

  change in inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up

Study Arms (1)

Hip Biofeedback

EXPERIMENTAL

Training: Participants will complete three training bouts in a session. For these training bouts, participants will be instructed to walk around the perimeter of the 9m x 15m laboratory while wearing the custom gait biofeedback device and visual display glasses. The training bouts will each be 6 minutes in duration with a 5-minute break in between bouts. The biofeedback will be intermittent, with one minute on and one minute off, in order for the individual to not become dependent on the feedback and to promote motor learning. Participants will be told that the device measures the angle their paretic leg is at, and as they move their leg, the line on the screen will move. They will be shown as they move their leg farther back, the line moves up, closer to the target. Participants will not be given specific feedback on what walking strategies to use to increase hip extension angle. If the participant surpasses the target hip extension angle, the target will blink green.

Other: Overground Visual Biofeeback

Interventions

Overground Visual Biofeeback OTHER

Subjects participate in biofeedback training for 3 6-minute bouts in a single session.

Hip Biofeedback

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Multiple strokes
• Complaints of cardiorespiratory or musculoskeletal disorders that would affect walking
• Visual deficits or hemi-neglect
• Other neurologic disorders beyond stroke

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska at Omaha

Omaha, Nebraska, 68182, United States

Location

Related Publications (1)

• Hinton EH, Buffum R, Kingston D, Stergiou N, Kesar T, Bierner S, Knarr BA. Real-Time Visual Kinematic Feedback During Overground Walking Improves Gait Biomechanics in Individuals Post-Stroke. Ann Biomed Eng. 2024 Feb;52(2):355-363. doi: 10.1007/s10439-023-03381-0. Epub 2023 Oct 23.

  PMID: 37870663 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Brian A Knarr, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 15, 2022
• Study Start: January 1, 2023
• Primary Completion: October 16, 2024
• Study Completion: October 16, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)