Clinical trial NCT04411303: A Novel, Comprehensive Approach to Post-stroke Gait Rehabilitation
Official title: A Novel, Comprehensive Approach to Post-stroke Gait Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: CVA (Cerebrovascular Accident)
Keywords: stroke
walking
rehabilitation
aerobic exercise
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Interlimb Asymmetry - change in performance
timeFrame: Measured 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
Secondary outcomes:
measure: Interlimb asymmetry - immediate retention
timeFrame: Measured after biofeedback training in each testing session; participants will complete 3 testing sessions over approximately 2 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Kristan Leech, PT, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: