Ankle Robotics After Stroke

Description

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).

Conditions

Foot Drop, Stroke, Hemiparesis

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Study Overview

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Study Details

Study overview

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).

Portable Ankle Robotics to Reverse Foot Drop After Stroke

Ankle Robotics After Stroke

Condition
Foot Drop
Intervention / Treatment

-

Contacts and Locations

Baltimore

University of Maryland Rehabilitation & Orthopaedic Institute, Baltimore, Maryland, United States, 21207

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NextStep Robotics Inc.,

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

Study Record Dates

2025-02-28