Ankle Robotics After Stroke Recovery

This study is testing a portable ankle robot called AMBLE to help people who have experienced a stroke and have foot drop (difficulty lifting the front part of the foot). Researchers want to see if using the AMBLE robot during physical therapy (PT) helps improve walking more than PT alone. You might be able to join if you are 18 or older and have foot drop due to a stroke, either recently (subacute phase: 6 weeks to 6 months post-stroke) or longer ago (chronic phase: more than 6 months post-stroke). The study will measure changes in how you walk, such as ankle angles and how many times your heel touches the ground first. The study aims to enroll 140 participants, but its current status is unclear.

Study design: This is a randomized study comparing robot-assisted physical therapy to physical therapy alone. It is in Phase II and aims to enroll 140 participants.
What's involved: Participants will receive 18 one-hour physical therapy sessions over 9 weeks. Some participants may have the option to re-enroll for robot-assisted therapy.
Compensation: Not stated in the trial record.
Follow-up: Your walking will be assessed at 9 weeks and again at 21 weeks after starting the therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Ankle Robotics After Stroke

Recruiting

NAAges 18+InterventionalTreatment

NextStep Robotics Inc.

~140 participants

Updated 2023-01-26 on ClinicalTrials.gov

What's tested: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.

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Angle at Initial Contact

Measured over Change from Baseline at both 9 Weeks and at 21 Weeks

+3 more outcomes measured

Conditions

Foot Drop

Stroke

Hemiparesis

Where it's being run

1 sites across 1 states

Maryland1

Study leadership

Brad Hennessie, MHA, MBA · STUDY_DIRECTOR · NextStep Robotics Inc.

Who to contact

Josh Rudnicki

[email protected]

443-869-3518

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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.

What this trial measures

Angle at Initial ContactChange from Baseline at both 9 Weeks and at 21 Weeks
Angle at initial contact averaged across each gait cycle for each subject at a given testing time point.
Swing DorsiflexionChange from Baseline at both 9 Weeks and at 21 Weeks
Peak swing dorsiflexion averaged across each gait cycle for each subject at a given testing time point.
Number of Heel-First Foot StrikesChange from Baseline at both 9 Weeks and at 21 Weeks
Number of heel-first foot strikes for each subject at a given testing time point.
Gait VelocityChange from Baseline at both 9 Weeks and at 21 Weeks
Average gait velocity (meters/second) for each subject at a given testing time point.

Trialytics