NCT04411303

A Novel, Comprehensive Approach to Post-stroke Gait Rehabilitation

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this project is to determine the feasibility and optimal parameters of a novel, comprehensive approach to gait training in individuals with chronic stroke. The comprehensive approach includes biofeedback-based gait training and aerobic exercise intensity-based gait training.

Detailed description

The goal of this project is to determine the feasibility and optimal parameters of a novel, comprehensive approach to gait training in individuals with chronic stroke. Current post-stroke gait training follows two distinct approaches that target different domains of gait dysfunction (as defined by the International Classification of Functioning, Health, and Disability). Biofeedback-based gait training is typically employed to treat walking pattern impairments (e.g., kinematic deviations relative to able-bodied controls); whereas, aerobic exercise intensity-based gait training is the current gold-standard to treat walking activity limitations (e.g., slow walking speeds). Here, the investigators propose to test the impact of combining these approaches into a single intervention to work toward the development of a more effective, comprehensive approach to gait rehabilitation for persons post-stroke. The central hypothesis is that individuals with chronic stroke have the capacity to use biofeedback to reduce kinematic gait deviations while walking at a range of recommended aerobic exercise intensity zones. Aim 1 will identify the gait biofeedback variable that elicits the largest reduction in interlimb asymmetry in persons post-stroke. Aim 2 will determine the capacity for persons post-stroke to make biofeedback-driven reductions in their interlimb asymmetry while walking at three different aerobic exercise intensities. Participants with chronic stroke in Aim 1 will each complete three experimental sessions and participants in Aim 2 will complete 1 experimental session. Biomechanical analyses and physiologic assessments will be used across both aims to test our working hypotheses. The investigators expect to show that biofeedback of paretic propulsion leads to the greatest reduction in interlimb asymmetry and that participants have the capacity to make biofeedback-driven interlimb asymmetry reductions while walking at all three aerobic intensities, but the magnitude of reduction will be the largest at a moderate aerobic walking intensity. The proposed work is innovative because it will be the first to test the relative effects of different gait biofeedback variables on whole lower extremity kinematics in persons post-stroke and test a novel combination of two well-established gait training approaches (biofeedback- and intensity-based) for neurologic patient populations. This is a critical next step in moving the post-stroke gait rehabilitation field forward. If successful, this line of work stands to significantly improve the current standard of care in gait rehabilitation post-stroke.

Conditions

• CVA (Cerebrovascular Accident)

Interventions

Type	Name	Description
BEHAVIORAL	Step length biofeedback	Participants will be provided with visual feedback of their right and left step lengths on a screen in front of a treadmill.
BEHAVIORAL	Propulsive force biofeedback	Participants will be provided with real-time visual feedback of anterior-posterior ground reaction forces of the paretic limb during stance phase on a screen in front of a treadmill.
BEHAVIORAL	Interlimb asymmetry biofeedback	Participants will be provided with visual feedback of stride-by-stride values of their interlimb asymmetry on a screen in front of a treadmill.
BEHAVIORAL	Aerobic intensity-based walking	Participants will walk at three different aerobic intensities. Aerobic intensity will be set based on target heart rate zones calculated with the Karvonen Formula. For low intensity, participants will walk at 30-40% intensity. In moderate intensity conditions, participants will walk at a 50-60% intensity level. In vigorous intensity conditions, participants will walk at an 70-80% intensity level. Aerobic intensity will be manipulated by changing walking speed.

Timeline

• Start date: 2021-06-09
• Primary completion: 2024-08-14
• Completion: 2025-12-14
• First posted: 2020-06-02
• Last updated: 2025-11-04

Locations

1 site across 1 country: United States