MedPath

A Novel, Comprehensive Approach to Post-stroke Gait Rehabilitation

Phase 1
Recruiting
Conditions
CVA (Cerebrovascular Accident)
Interventions
Behavioral: Aerobic intensity-based walking
Behavioral: Step length biofeedback
Behavioral: Propulsive force biofeedback
Behavioral: Interlimb asymmetry biofeedback
Registration Number
NCT04411303
Lead Sponsor
University of Southern California
Brief 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
50
Inclusion Criteria
  • >6 months post stroke, affecting 1 hemisphere of the brain
  • Independently ambulatory (including use assistive devices)
  • Able to walk for 5 minutes without stopping
  • Demonstrates readiness for exercise based on responses to the PAR-Q+
  • Participants enrolled in Aim 2 will require medical clearance from physician to participate
Exclusion Criteria
  • Damage to the pons or cerebellum on MRI or signs of cerebellar involvement

  • Damage to the basal ganglia or extrapyramidal symptoms

  • Uncontrolled hypertension (>160/100mmHg)

  • Montreal Cognitive Assessment score < 25

  • Orthopedic or pain conditions

    • Note*: Pregnant women are excluded from this study to avoid any potential harm to the fetus from the harness used during treadmill walking.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Reducing interlimb asymmetry with biofeedback post-strokePropulsive force biofeedbackWe will use a randomized crossover design to determine the performance and retention effects following single-day training sessions with biofeedback of three different gait variables (i.e., step length, propulsive force, and interlimb asymmetry) in 25 individuals with chronic stroke.
Reducing interlimb asymmetry with biofeedback post-strokeInterlimb asymmetry biofeedbackWe will use a randomized crossover design to determine the performance and retention effects following single-day training sessions with biofeedback of three different gait variables (i.e., step length, propulsive force, and interlimb asymmetry) in 25 individuals with chronic stroke.
Evaluating capacity for biofeedback use at varied intensitiesAerobic intensity-based walkingWe will use a within-session randomized crossover design to test the capacity of persons post-stroke (second cohort; n=25) to reduce their interlimb asymmetry using the biofeedback variable found to be the most effective for the group in Aim 1 while walking in three aerobic intensity zones: low, moderate, and vigorous (30-40%, 50-60%, and 70-80% of heart rate reserve, respectively).
Reducing interlimb asymmetry with biofeedback post-strokeStep length biofeedbackWe will use a randomized crossover design to determine the performance and retention effects following single-day training sessions with biofeedback of three different gait variables (i.e., step length, propulsive force, and interlimb asymmetry) in 25 individuals with chronic stroke.
Primary Outcome Measures
NameTimeMethod
Interlimb Asymmetry - change in performanceMeasured at three timepoints of interest within each testing session: baseline and at the beginning and end of the biofeedback training; participants will complete 3 testing sessions over approximately 2 months

characterized as a comparison between the right and left legs of whole lower limb kinematics at heel strike; captured to quantify change in performance with biofeedback

Secondary Outcome Measures
NameTimeMethod
Interlimb asymmetry - immediate retentionMeasured after biofeedback training in each testing session; participants will complete 3 testing sessions over approximately 2 months

characterized as a comparison between the right and left legs of whole lower limb kinematics at heel strike; captured to quantify retention of a newly learned walking pattern

Trial Locations

Locations (1)

University of Southern California

🇺🇸

Los Angeles, California, United States

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