← Back to Search

Comprehensive Gait Rehabilitation for Post-Stroke Recovery

Phase 1
Recruiting
Led By Kristan Leech, PT, DPT, PhD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured after biofeedback training in each testing session; participants will complete 3 testing sessions over approximately 2 months
Awards & highlights

Study Summary

This trial will test a new, two-part approach to helping people with chronic stroke walk better. The first part is biofeedback-based gait training, the second part is aerobic exercise-based gait training.

Who is the study for?
This trial is for individuals who are more than 6 months post-stroke, affecting one side of the brain. They must be able to walk independently (with or without assistive devices) for at least 5 minutes and have a physician's clearance. Pregnant women, those with certain brain damages, uncontrolled high blood pressure, low cognitive scores, or severe orthopedic conditions cannot participate.Check my eligibility
What is being tested?
The study tests a new gait training method combining biofeedback (on step length and limb symmetry) with aerobic exercise intensity-based walking in chronic stroke survivors. The aim is to find out how feasible this approach is and what the best settings are for these exercises.See study design
What are the potential side effects?
Potential side effects aren't specified but may include fatigue due to exercise and discomfort from using any equipment like harnesses during treadmill walking as part of the rehabilitation process.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured after biofeedback training in each testing session; participants will complete 3 testing sessions over approximately 2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured after biofeedback training in each testing session; participants will complete 3 testing sessions over approximately 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Interlimb Asymmetry - change in performance
Secondary outcome measures
Interlimb asymmetry - immediate retention

Trial Design

2Treatment groups
Experimental Treatment
Group I: Reducing interlimb asymmetry with biofeedback post-strokeExperimental Treatment3 Interventions
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 II: Evaluating capacity for biofeedback use at varied intensitiesExperimental Treatment1 Intervention
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).

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,596,238 Total Patients Enrolled
22 Trials studying Stroke
5,018 Patients Enrolled for Stroke
Kristan Leech, PT, DPT, PhDPrincipal InvestigatorUniversity of Southern California
1 Previous Clinical Trials
65 Total Patients Enrolled
1 Trials studying Stroke
65 Patients Enrolled for Stroke

Media Library

Aerobic intensity-based walking Clinical Trial Eligibility Overview. Trial Name: NCT04411303 — Phase 1
Stroke Research Study Groups: Reducing interlimb asymmetry with biofeedback post-stroke, Evaluating capacity for biofeedback use at varied intensities
Stroke Clinical Trial 2023: Aerobic intensity-based walking Highlights & Side Effects. Trial Name: NCT04411303 — Phase 1
Aerobic intensity-based walking 2023 Treatment Timeline for Medical Study. Trial Name: NCT04411303 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an option for me to join this medical research?

"This research initiative is in the process of sourcing 50 individuals with a cerebrovascular accident between 18-80 years old. To qualify, applicants must be independently ambulatory (including use of any necessary assistive device), able to walk for 5 minutes at a time without pause, and receive medical clearance from their physician if they are participating in Aim 2."

Answered by AI

Are any spots open for this current clinical trial?

"As indicated on clinicaltrials.gov, this medical endeavour is actively seeking participants; it was first posted on June 6th 2021 and recently updated as of March 9th 2022."

Answered by AI

Has the Food & Drug Administration given authorization for Interlimb asymmetry biofeedback?

"Interlimb asymmetry biofeedback has yet to be fully evaluated, so it achieved a score of 1. This Phase 1 trial is limited in its ability to provide empirical evidence regarding the safety and efficacy of this intervention."

Answered by AI

Are there restrictions on how many persons can join this trial?

"Affirmative. Clinicaltrials.gov documents that this research experiment, which was initially posted on June 6th 2021, is currently enlisting volunteers. Approximately 50 individuals will be sought from a single hospital to join the trial.."

Answered by AI

Are participants over the age of 75 being included in this research?

"This study is recruiting individuals who are of legal age or over, and not yet 80 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Novel, Comprehensive Approach to Post-stroke Gait Rehabilitation
Kristan Leech 2021. "A Novel, Comprehensive Approach to Post-stroke Gait Rehabilitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04411303.
~8 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top