Movement Amplification Gait Training to Enhance Walking Balance Post-Stroke

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Stroke is a leading cause of disability in the United States, affecting approximately 795,000 people annually. The Veteran's Health Administration provides over 60,000 outpatient visits for stroke-related care annually at a cost of over $250 million. Among ambulatory people with chronic stroke (PwCS), impaired balance is a common health concern that substantially limits mobility (those with the worst balance walk the least). This project will explore adaptive strategies employed by PwCS in balance challenging environments and if a novel gait training intervention using a robotic device to amplify a person's self-generated movements can improve walking balance. The development of effective interventions to increase walking balance among PwCS will positively impact Veterans' health, quality of life, and ability to participate in walking activities.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• History of chronic stroke (more than 6 months post-stroke) with weakness on one side

• Ability to ambulate over ground for 10 meters with or without a single cane, and/or ankle-foot orthosis

• Ability to tolerate 10 minutes of standing

Locations
United States
Illinois
Northwestern University
NOT_YET_RECRUITING
Chicago
Edward Hines Jr. VA Hospital, Hines, IL
RECRUITING
Hines
Contact Information
Primary
Keith E Gordon, PhD
Keith.Gordon2@va.gov
(708) 202-8387
Time Frame
Start Date: 2024-08-15
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 30
Treatments
Experimental: Biomechanical Response to Balance Challenging Environments
Aim 1 will determine how people with chronic stroke (PwCS) adapt their gait in response to different balance challenging environments. For Aim 1, the investigators will conduct a single-session cross sectional study to assess gait patterns during and immediately following walking practiced in balance challenging environments. PwCS will perform treadmill walking in a natural unmodified environment, and in two balance-challenging environments that will include a Movement Amplification Environment (MAE), and an unpredictable lateral perturbation environment. All enrolled participants will undergo clinical outcome measure assessments to identify baseline function. In addition, all participants in Aim 1 will undergo biomechanical testing while walking in each of the three environments to assess changes in their walking patterns.
Experimental: Heart Rate Response to Balance Challenging Environments
Aim 2 is a feasibility study to determine if high intensity gait training can be achieved within a MAE. For Aim 2, the investigators will employ a two-way cross over study design consisting of two gait training sessions (one in a natural unmodified environment and the other in a MAE). The investigators will examine cardiovascular response, perceived exertion, and gait characteristics (speed, number of steps) to quantify if the MAE impacts training intensity. All enrolled participants will undergo clinical outcome measure assessments. In addition, all participants for Aim 2, heart rate (HR), rate of perceived exertion (RPE), number of steps taken during the training sessions, and walking speeds will be recorded.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development
Collaborators: Northwestern University

This content was sourced from clinicaltrials.gov