NCT04594837Recruiting
Ankle Robotics After Stroke
Portable Ankle Robotics to Reverse Foot Drop After Stroke
Source: ClinicalTrials.gov · Last updated 26 Jan 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 14 Oct 2020
- Start date
- 20 Aug 2020
- Primary completion date
- 28 Feb 2025
- Lead sponsor
- NextStep Robotics Inc.
- Diseases
- Stroke
- NCT number
- NCT04594837
What you commit to
- Study type: Interventional
- Planned participants: 140
- From 20 Aug 2020 to the primary completion date, 28 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Aphasia or cognitive functioning that confounds participation, defined as unable to follow 2 step commands or judgment of the medical officer or therapist.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Maryland Rehabilitation & Orthopaedic Institute Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
Related publications
- Adaptive control ankle robotics training durably improves gait biomechanics in chronic hemiparetic stroke and footdrop.J Neuroeng Rehabil · 2025 · PMID 41462280
This page is information, not medical advice. Discuss any trial with your doctor.