A Novel, Comprehensive Approach to Post-stroke Gait Rehabilitation

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University of Southern California

Status and phase

Enrolling
Phase 1

Conditions

CVA (Cerebrovascular Accident)

Treatments

Behavioral: Step length biofeedback
Behavioral: Aerobic intensity-based walking
Behavioral: Interlimb asymmetry biofeedback
Behavioral: Propulsive force biofeedback

Study type

Interventional

Funder types

Other

Identifiers

NCT04411303
HS-20-01887

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Reducing interlimb asymmetry with biofeedback post-stroke
Experimental group
Description:
We 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.
Treatment:
Behavioral: Propulsive force biofeedback
Behavioral: Interlimb asymmetry biofeedback
Behavioral: Step length biofeedback
Evaluating capacity for biofeedback use at varied intensities
Experimental group
Description:
We 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).
Treatment:
Behavioral: Aerobic intensity-based walking

Trial contacts and locations

1

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Central trial contact

Kristan Leech, PT, DPT, PhD; Sarah Kettlety, MS

Data sourced from clinicaltrials.gov

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