Wearable ankle robot therapy for post-stroke foot drop

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with hemiparetic foot drop from recent or prior stroke are randomized to 9 weeks (18 sessions) of robot-assisted physical therapy using a portable ankle device (AMBLE) or to conventional physical therapy without the robot. Therapy is delivered during over-ground mobility training and the robot provides timely, step-by-step assistance to shape ankle dorsiflexion and motor learning. Primary outcomes include gait biomechanics (ankle angle at initial contact, peak swing ankle angle, percent heel-first strikes, gait velocity) and blinded clinician measures of dorsiflexion range, ankle strength, and assistive device needs. The design includes subacute and chronic stroke cohorts and a crossover subgroup to examine durability and generalizability of effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Maryland Rehabilitation & Orthopaedic Institute
  Baltimore, Maryland, United States Recruiting

Study contacts

• Study coordinator: Josh Rudnicki
• Email: JRudnicki@som.umaryland.edu
• Phone: 443-869-3518

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.