RecruitingFoot DropStrokeHemiparesis
Ankle Robotics After Stroke
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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).
Sponsor: NextStep Robotics Inc.
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's recruiting
Maryland
Baltimore
Source: ClinicalTrials.gov · NCT04594837 · last updated 2023-01-26