Wearable ankle robot therapy for post-stroke foot drop

Portable Ankle Robotics to Reverse Foot Drop After Stroke

This study will test whether adding a wearable ankle robot to physical therapy helps adults with post-stroke foot drop walk better than physical therapy alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: NextStep Robotics Inc. (industry)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT04594837 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (age 18+) with hemiparetic gait and persistent foot drop in the subacute (>6 weeks to <6 months) or chronic (>6 months) phase after stroke who can participate in over-ground gait training are ideal candidates.

Not a fit: People with unstable cardiac disease, severe medical or orthopedic conditions that substantially alter gait, or those unable to participate in over-ground walking sessions are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the device could improve ankle lifting and walking speed, reduce reliance on braces or canes, and lower fall risk for people with post-stroke foot drop.

How similar studies have performed: Previous robot-assisted gait and ankle-assist approaches have shown promising improvements in ankle function and walking in some studies, but portable over-ground ankle robotics remain less extensively studied.

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.

Where this trial is running

Baltimore, Maryland

• University of Maryland Rehabilitation & Orthopaedic Institute — Baltimore, Maryland, United States (RECRUITING)

Study contacts

• Study coordinator: Josh Rudnicki

Conditions: Foot Drop, Stroke, Hemiparesis