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โ† Trials
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Ankle Robotics After Stroke

RecruitingNAAges 18 Years - anyAllNextStep Robotics Inc.
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • PTR Physical Therapy while wearing Robot group (Phase II)
  • Physical Therapy Only (Phase II)
  • Cross over group for Physical Therapy n Sub-Acute group. (Phase II)
  • Chronic Stroke Subjects to receive robotic gait training therapy.
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Where

1 site
University of Maryland Rehabilitation & Orthopaedic Institute
Baltimore, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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