NCT06400186 · VA Office of Research and Development
Movement Amplification Gait Training to Enhance Walking Balance Post-Stroke
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
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 measures
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.
Lateral COM excursion is the peak-to-peak distance the COM moves from side-to-side during a complete gait cycle. This distance is measured in meters. Smaller values indicate better ability to control motion during walking.
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.
Minimum lateral margin of stability is the smallest distance between the lateral extrapolated center of mass position (XCOM) and the lateral base of support (BOS), approximated as the lateral position of the 5th metatarsal marker on the side of the last initial contact. Minimum MOS is identified during stance phase of each step. Extrapolated center of mass (XCOM) position is calculated using: XCOM= COM + COM\* l/g The minimum lateral margin of stability is calculated in meters. Smaller values indicate greater ability to control motion during walking.
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.
Participants heart rate in beats per minute (bpm) will be collected to determine cardiovascular response to exercise. Larger heart rates will indicate a stronger cardiovascular response to exercise.
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
Participants exertion monitored via 6-20 point rate of perceived exertion scale and heart rate will be collected to determine participants performance during each training session and track their progress. Minimum score for perceived exertion is 6 and maximum score is 20. Higher score indicates greater exertion and lower score indicates less exertion.
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
Treadmill speed is a measure of how fast a person is walking on a treadmill. This measure is in units of meters/second. Higher values indicate faster walking speeds.
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.
An activity monitor worn on the ankle during treadmill walking will identify and record each time a person takes a step. A higher number will indicate a greater number of steps were taken.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chicago, Illinois
- Hines, Illinois
Collaborators
Northwestern University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 14, 2026 · Source of record for eligibility and locations