A Novel, Comprehensive Approach to Post-stroke Gait Rehabilitation

NCT04411303 | Active Not Recruiting Phase 1

• 1 other identifier: HS-20-01887
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

CVA (Cerebrovascular Accident)

Keywords

stroke; walking; rehabilitation; aerobic exercise

Outcome Measures

Primary Outcomes (1)

• Interlimb Asymmetry - change in performance

  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

  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 (1)

• Interlimb asymmetry - immediate retention

  Measured after biofeedback training in each testing session; participants will complete 3 testing sessions over approximately 2 months

Study Arms (2)

Reducing interlimb asymmetry with biofeedback post-stroke

EXPERIMENTAL

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.

Behavioral: Step length biofeedback; Behavioral: Propulsive force biofeedback; Behavioral: Interlimb asymmetry biofeedback

Evaluating capacity for biofeedback use at varied intensities

EXPERIMENTAL

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).

Behavioral: Aerobic intensity-based walking

Interventions

Step length biofeedback BEHAVIORAL

Participants will be provided with visual feedback of their right and left step lengths on a screen in front of a treadmill.

Reducing interlimb asymmetry with biofeedback post-stroke

Propulsive force biofeedback BEHAVIORAL

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.

Reducing interlimb asymmetry with biofeedback post-stroke

Interlimb asymmetry biofeedback BEHAVIORAL

Participants will be provided with visual feedback of stride-by-stride values of their interlimb asymmetry on a screen in front of a treadmill.

Reducing interlimb asymmetry with biofeedback post-stroke

Aerobic intensity-based walking BEHAVIORAL

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.

Evaluating capacity for biofeedback use at varied intensities

Eligibility Criteria

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

You may qualify if:

• \>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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

Location

Related Publications (2)

• Kettlety SA, Finley JM, Leech KA. Within-session propulsion asymmetry changes have a limited effect on gait asymmetry post-stroke. J Neuroeng Rehabil. 2025 Jan 22;22(1):9. doi: 10.1186/s12984-025-01553-8.

  PMID: 39844188 DERIVED

• Kettlety SA, Finley JM, Leech KA. Within-session propulsion asymmetry changes have a limited effect on gait asymmetry post-stroke. Res Sq [Preprint]. 2024 Dec 23:rs.3.rs-5053605. doi: 10.21203/rs.3.rs-5053605/v1.

  PMID: 39764092 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Kristan Leech, PT, DPT, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: June 2, 2020
• Study Start: June 9, 2021
• Primary Completion: August 14, 2024
• Study Completion: December 14, 2025
• Last Updated: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Data will be available 6 months after publication.

Locations

US (1)