A Novel, Comprehensive Approach to Post-stroke Gait Rehabilitation

NCT ID: NCT04411303

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-09
• Study Completion Date: 2025-12-14

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.

Conditions

CVA (Cerebrovascular Accident)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Reducing interlimb asymmetry with biofeedback post-stroke

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.

Group Type: EXPERIMENTAL

Step length biofeedback

Intervention Type: BEHAVIORAL

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

Propulsive force biofeedback

Intervention Type: 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.

Interlimb asymmetry biofeedback

Intervention Type: 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.

Evaluating capacity for biofeedback use at varied intensities

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).

Group Type: EXPERIMENTAL

Aerobic intensity-based walking

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Kristan Leech

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristan Leech, PT, DPT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

University of Southern California

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39844188 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39764092 (View on PubMed)

Other Identifiers

HS-20-01887

Identifier Type: -

Identifier Source: org_study_id