Movement Amplification Gait Training to Enhance Walking Balance Post-Stroke

Conditions

• Chronic Hemiparetic Stroke

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• High intensity gait training in varying external environments — BEHAVIORAL
  Participants will engage in two 45-minutes treadmill-based gait training sessions. These training sessions will occur on separate days. One session will be performed in a natural unmodified environment. One session will be performed in a movement amplification environment. The goal of each session will be to achieve 40-minutes of walking within a target heart rate range of 70-85% of estimated heart rate max. Each session will begin and end with a 2.5 minute warm-up and cool down respectively. Participants will be given rest breaks as needed.
• Treadmill walking in varying external environments — BEHAVIORAL
  Participants will perform a series of treadmill walking trials. Each trial will consist of 400 total steps. The first 100 steps will be performed in a natural unmodified environment. The next 200 steps will be performed in 1 of 3 external environments (natural unmodified, movement amplification, or unpredictable lateral perturbations). The final 100 steps will be performed in a natural unmodified environment. Participants will be given rest breaks between trials.

Study Details

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.

Key Dates

Start date

Aug 15, 2024

Status verified

Aug 2025

Primary completion

May 31, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

30 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Lateral center of mass (COM) excursion during walking [ Time Frame: Arm 1 only: On Day 1 of the study, participants will perform three 5-minute treadmill walking trials. We will measure Lateral COM excursion every gait cycle during each trial. ]

Central Contacts

• Keith E Gordon, PhD
  (708) 202-8387
  [email protected]

Locations (2)

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