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Ankle Robotics After Stroke

NextStep Robotics Inc. · NCT04594837

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
140
US sites recruiting
1
Study start
August 20, 2020
Record last updated
January 26, 2023

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: 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.

Conditions: Foot Drop; Stroke; Hemiparesis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • University of Maryland Rehabilitation & Orthopaedic Institute

    Baltimore, MD 21207

    Site contact: Josh Rudnicki · 443-869-3518 · JRudnicki@som.umaryland.edu

Study contacts (from the official record)

  • Josh Rudnicki · 443-869-3518 · JRudnicki@som.umaryland.edu
  • Richard Macko, MD
All neurology studies in Maryland →
Ankle Robotics After Stroke (NCT04594837) | Bored Studies