Movement Amplification Gait Training to Enhance Walking Balance Post-Stroke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorVA Office of Research and Development

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Biomechanical Response to Balance Challenging EnvironmentsExperimental treatment 1 intervention
Group B: Heart Rate Response to Balance Challenging EnvironmentsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Lateral center of mass (COM) excursion during walking

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.

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.
2

Minimum lateral margin of stability

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.

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.
3

Heart Rate

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.

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.
4

Perceived Exertion (RPE)

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.

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

Secondary outcomes

1

Step Length

Step length is calculated as the fore-aft distance between the calcanei markers at initial foot contact. This distance is measured in meters. Larger values indicate longer steps.

Time frame
Arm 1 only: On Day 1 of the study, participants will perform three 5-minute treadmill walking trials. We will measure step length every gait cycle during each trial.
2

Step Width

Step width is calculated as the medio-lateral distance between the left and right 5th Metatarsal markers at initial foot contact. This value is measured in meters. Larger values indicate a wider step.

Time frame
Arm 1 only: On Day 1 of the study, participants will perform three 5-minute treadmill walking trials. We will measure step width every gait cycle during each trial.
3

10 Meter Walk Test (10MWT)

10MWT is a simple measurement of an individual's average walking speed measured at self-selected speed (instruction: "walk at your normal comfortable pace") and fastest-possible speed (instruction: "as fast as you safely can").

Time frame
The 10MWT will be administered one time only. This test will be administered on Day 1 before the study intervention has been administered.
4

Timed Up and Go (TUG)

TUG is used to assess functional mobility, walking balance, and fall risk. It is a quick, valid, reliable and widely used clinical performance based measure in individuals post-stroke. While there is no time limit to the TUG test, more time taken to finish the task indicates poor balance and greater fall-risk.

Time frame
The TUG will be administered one time only. This test will be administered on Day 1 before the study intervention has been administered.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Northwestern University

Collaborator