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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured after biofeedback training in each testing session; participants will complete 3 testing sessions over approximately 2 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Interlimb Asymmetry - change in performance

Secondary study objectives

Interlimb asymmetry - immediate retention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

Do I qualify?Apply below to find out