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A Novel, Comprehensive Approach to Post-stroke Gait Rehabilitation

Primary Purpose

CVA (Cerebrovascular Accident)

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Step length biofeedback
Propulsive force biofeedback
Interlimb asymmetry biofeedback
Aerobic intensity-based walking
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for CVA (Cerebrovascular Accident) focused on measuring stroke, walking, rehabilitation, aerobic exercise

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Southern CaliforniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Reducing interlimb asymmetry with biofeedback post-stroke

Evaluating capacity for biofeedback use at varied intensities

Arm 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.

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Interlimb asymmetry - immediate retention
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

Full Information

First Posted
May 19, 2020
Last Updated
July 8, 2023
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT04411303
Brief Title
A Novel, Comprehensive Approach to Post-stroke Gait Rehabilitation
Official Title
A Novel, Comprehensive Approach to Post-stroke Gait Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2021 (Actual)
Primary Completion Date
December 14, 2023 (Anticipated)
Study Completion Date
December 14, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CVA (Cerebrovascular Accident)
Keywords
stroke, walking, rehabilitation, aerobic exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reducing interlimb asymmetry with biofeedback post-stroke
Arm Type
Experimental
Arm 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.
Arm Title
Evaluating capacity for biofeedback use at varied intensities
Arm Type
Experimental
Arm 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).
Intervention Type
Behavioral
Intervention Name(s)
Step length biofeedback
Intervention Description
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
Intervention Name(s)
Propulsive force biofeedback
Intervention Description
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
Intervention Name(s)
Interlimb asymmetry biofeedback
Intervention Description
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
Intervention Name(s)
Aerobic intensity-based walking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Interlimb Asymmetry - change in performance
Description
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
Time Frame
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 Outcome Measure Information:
Title
Interlimb asymmetry - immediate retention
Description
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
Time Frame
Measured after biofeedback training in each testing session; participants will complete 3 testing sessions over approximately 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristan Leech, PT, DPT, PhD
Phone
(323) 442-1583
Email
kleech@pt.usc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Kettlety, MS
Phone
(323) 442-1196
Email
kettlety@usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristan Leech, PT, DPT, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristan Leech, Phd

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All de-identified data from our research that underlie results in a publication will be made available.
IPD Sharing Time Frame
Data will be available 6 months after publication.

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A Novel, Comprehensive Approach to Post-stroke Gait Rehabilitation

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