Ankle Robot Therapy for Foot Drop After Stroke
Tests a portable ankle robot plus physical therapy in adults with foot drop after stroke.
Plain-language title generated from the registry record
Registry title: Ankle Robotics After Stroke
Key facts
- Where
- Baltimore, United StatesSee the site
Where in United States
- University of Maryland Rehabilitation & Orthopaedic InstituteBaltimore, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- NextStep Robotics Inc.
- Trial code
- NCT04594837
- Record updated
- 26 January 2023
- Original description
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).Read full original descriptionShow less
Portable Ankle Robotics to Reverse Foot Drop After Stroke
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).
Inclusion: 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: 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.