Recruiting

Movement AmplificationMovement Amplification Gait Training to Enhance Walking Balance Post-Stroke

Sponsor:

VA Office of Research and Development

Code:

NCT06400186

Conditions

Chronic Hemiparetic Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

High intensity gait training in varying external environments

Treadmill walking in varying external environments

Study Details

Brief 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.

Conditions

Chronic Hemiparetic Stroke

Study ID

NCT06400186

Start date

Aug 15, 2024

Status verified date

Aug, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

Presence of cognitive impairment (score of 22/30 on the Montreal Cognitive Assessment scale (MoCA))
Presence of aphasia (score of 71/100 on the Mississippi Aphasia Screening Test (MAST))
Excessive spasticity in lower limbs (score of > 3 on the Modified Ashworth Scale
Severe cardiovascular and pulmonary disease affecting gait and balance
History of recurrent fractures or known orthopedic problems in the lower extremities (i.e. heterotopic ossification) affecting gait and balance
Concomitant central or peripheral neurological injury (i.e. traumatic head injury or peripheral nerve damage in lower limbs) affecting gait and balance
Evidence of cerebellar ataxia
Presence of unhealed decubiti or other skin compromise
Enrollment in concurrent physical therapy or research involving gait or balance training
Use of braces/orthotics crossing the knee joint
Known pregnancy

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

High intensity gait training in varying external environments

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

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.

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. ]
Minimum lateral margin of stability [ Time Frame: Arm 1 only: On Day 1 of the study, participants will perform three 5-minute treadmill walking trials. We will measure minimum lateral margin of stability every gait cycle during each trial. ]
Heart Rate [ Time Frame: Arm 2 only: On Day 1, participants will perform 45 minutes of treadmill walking. Seven days later, participants will perform another 45 minutes of continuous treadmill walking. We will measure average HR during every 3-minutes of treadmill walking. ]
Perceived Exertion (RPE) [ Time Frame: Arm 2 only: On Day 1, participants will perform 45 minutes of treadmill walking. Seven days later, participants will perform another 45 minutes of continuous treadmill walking. We will measure average RPE during every 3-minutes of treadmill walking ]
Treadmill walking speed [ Time Frame: Arm 2 only: On Day 1, participants will perform 45 minutes of treadmill walking. Seven days later, participants will perform another 45 minutes of continuous treadmill walking. We will measure average speed during every 3-minutes of treadmill walking ]
Number of Steps [ Time Frame: Arm 2 only: On Day 1, participants will perform 45 minutes of treadmill walking. Seven days later, participants will perform another 45 minutes of continuous treadmill walking. We will measure the total number of steps during each day. ]

Central Contacts and Locations

Central contacts

Keith E Gordon, PhD

(708) 202-8387 Keith.Gordon2@va.gov

Locations

Edward Hines Jr. VA Hospital, Hines, IL

Recruiting

Hines, Illinois, United States, 60141-3030

Contacts

Keith E Gordon, PhD

(708) 202-8387 Keith.Gordon2@va.gov

Principal Investigator:

Keith Edward Gordon, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

gait
balance
walking
locomotion
stroke
rehabilitation robotics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-08-14.