Ankle Robotics After Stroke

Recruiting now · Not applicable

Conditions studied: Foot Drop, Stroke, Hemiparesis

In brief

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).

Key facts

Study ID

NCT04594837

Run by

NextStep Robotics Inc.

People needed

140

Starts

2020-08-20

Expected to finish

2025-02-28

Last updated by the study team

2023-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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