| NCT ID | NCT04594837 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NextStep Robotics Inc. |
| Condition | Foot Drop |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2020-08-20 |
| Primary Completion | 2025-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2020-08-20 with a primary completion date of 2025-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Brad Hennessie, MHA, MBA
STUDY DIRECTOR
NextStep Robotics Inc.
Frequently Asked Questions
Who can join the NCT04594837 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Foot Drop. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04594837 currently recruiting?
Yes, NCT04594837 is actively recruiting participants. Contact the research team at JRudnicki@som.umaryland.edu for enrollment information.
Where is the NCT04594837 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT04594837 clinical trial?
NCT04594837 is sponsored by NextStep Robotics Inc.. The principal investigator is Brad Hennessie, MHA, MBA at NextStep Robotics Inc.. The trial plans to enroll 140 participants.