- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04411303
A Novel, Comprehensive Approach to Post-stroke Gait Rehabilitation
March 22, 2024 updated by: Kristan Leech, University of Southern California
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.
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sarah Kettlety, MS
- Phone Number: (323) 442-1196
- Email: kettlety@usc.edu
Study Contact Backup
- Name: Kristan Leech, PT, DPT, PhD
- Phone Number: (323) 442-1583
- Email: kleech@pt.usc.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90089
- Recruiting
- University of Southern California
-
Contact:
- Kristan Leech, Phd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Participants will be provided with visual feedback of their right and left step lengths on a screen in front of a treadmill.
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.
Participants will be provided with visual feedback of stride-by-stride values of their interlimb asymmetry on a screen in front of a treadmill.
|
Experimental: 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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interlimb Asymmetry - change in performance
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interlimb asymmetry - immediate retention
Time Frame: Measured after biofeedback training in each testing session; participants will complete 3 testing sessions over approximately 2 months
|
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
|
Measured after biofeedback training in each testing session; participants will complete 3 testing sessions over approximately 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kristan Leech, PT, DPT, PhD, University of Southern California
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 2021
Primary Completion (Estimated)
December 14, 2024
Study Completion (Estimated)
December 14, 2025
Study Registration Dates
First Submitted
May 19, 2020
First Submitted That Met QC Criteria
May 27, 2020
First Posted (Actual)
June 2, 2020
Study Record Updates
Last Update Posted (Actual)
March 26, 2024
Last Update Submitted That Met QC Criteria
March 22, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-20-01887
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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