Ankle Robotics After Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNextStep Robotics Inc.
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- PTR Physical Therapy while wearing Robot group (Phase II)
- Physical Therapy Only (Phase II)
- Cross over group for Physical Therapy n Sub-Acute group. (Phase II)
- Chronic Stroke Subjects to receive robotic gait training therapy.
Treatment groups
140 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov