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Ankle Robotics After Stroke
Portable Ankle Robotics to Reverse Foot Drop After Stroke
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Ages 18 and older * In the subacute phase of stroke recovery (\>6 weeks to \<6 months post-stroke) with residual hemiparesis of the lower extremity that includes symptoms of foot-drop. - or - In the chronic phase of stroke recovery (\>6 months post-stroke) with residual hemiparesis of the lower extremity that includes symptoms of foot-drop. * Clear indications of hemiparetic gait by clinical observation Exclusion Criteria: * Cardiac history of (a) unstable angina, (b) recent (less than 3 months) myocardial infarction, congestive heart failure (NYHA category II); (c) hemodynamically significant valvular dysfunction * Hypertension that is a contraindication for routine physical therapy (greater than 160/100 on two assessments). * Medical History: (a) recent hospitalization (less than 3 months) for severe medical disease, (b) symptomatic peripheral arterial occlusive disease, (c) orthopedic or chronic pain conditions that significantly alter gait function, (d) pulmonary or renal failure (e) active cancer * History of non-stroke neuromuscular disorder restricting gait. * Aphasia or cognitive functioning that confounds participation, defined as unable to follow 2 step commands or judgment of the medical officer or therapist.
About the study
The randomized study (in Phase II of the U44) compares the efficacy and durability of 9 weeks (18 sessions) of robot-assisted physical therapy (PTR) versus physical therapy (PT) alone on foot drop as assessed by gait biomechanics (ankle angle at initial contact, peak swing ankle angle, number of heel-first strikes - % total steps, gait velocity) and blinded clinician assessment (dorsiflexion active range of motion, ankle muscle strength, assistive device needs).
What is being tested
- PTR Physical Therapy while wearing Robot group (Phase II) (device)
- Physical Therapy Only (Phase II) (other)
- Cross over group for Physical Therapy n Sub-Acute group. (Phase II) (device)
- Chronic Stroke Subjects to receive robotic gait training therapy. (device)
Sponsor: NextStep Robotics Inc. · Participants: 140 · Started: Aug 20, 2020
Contact the study team
- Josh Rudnicki · Phone: 443-869-3518
Official record on ClinicalTrials.gov — NCT04594837
Locations in the U.S.
| Maryland | University of Maryland Rehabilitation & Orthopaedic Institute, Baltimore |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.