RECRUITING

Ankle Robotics After Stroke

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

Portable Ankle Robotics to Reverse Foot Drop After Stroke

Quick Facts

Study Start:2020-08-20
Study Completion:2025-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04594837

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages 18 and older
  2. * 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.
  3. * Clear indications of hemiparetic gait by clinical observation
  1. * 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
  2. * Hypertension that is a contraindication for routine physical therapy (greater than 160/100 on two assessments).
  3. * 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
  4. * History of non-stroke neuromuscular disorder restricting gait.
  5. * Aphasia or cognitive functioning that confounds participation, defined as unable to follow 2 step commands or judgment of the medical officer or therapist.

Contacts and Locations

Study Contact

Josh Rudnicki
CONTACT
443-869-3518
JRudnicki@som.umaryland.edu
Richard Macko, MD
CONTACT

Principal Investigator

Brad Hennessie, MHA, MBA
STUDY_DIRECTOR
NextStep Robotics Inc.

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: NextStep Robotics Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-20
Study Completion Date2025-02-28

Study Record Updates

Study Start Date2020-08-20
Study Completion Date2025-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Foot Drop
  • Stroke
  • Hemiparesis