Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04594837

Ankle Robotics After Stroke

Led by NextStep Robotics Inc. · Updated on 2023-01-26

140

Participants Needed

1

Research Sites

236 weeks

Total Duration

On this page

AI-Summary

What this Trial 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).

CONDITIONS

Official Title

Ankle Robotics After Stroke

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • In subacute phase of stroke recovery (more than 6 weeks to less than 6 months post-stroke) with foot drop and partial paralysis of lower limb
  • Or in chronic phase of stroke recovery (more than 6 months post-stroke) with foot drop and partial paralysis of lower limb
  • Clinical signs of hemiparetic gait observed by clinician
Not Eligible

You will not qualify if you...

  • Unstable angina or recent myocardial infarction (less than 3 months)
  • Congestive heart failure (NYHA category II)
  • Significant heart valve problems
  • Hypertension over 160/100 on two separate assessments that contraindicates physical therapy
  • Recent hospitalization (less than 3 months) for severe medical illness
  • Symptomatic peripheral arterial occlusive disease
  • Orthopedic or chronic pain conditions significantly affecting walking
  • Pulmonary or kidney failure
  • Active cancer
  • Neuromuscular disorders unrelated to stroke that affect walking
  • Aphasia or cognitive impairments preventing following two-step commands or safe participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Maryland Rehabilitation & Orthopaedic Institute

Baltimore, Maryland, United States, 21207

Actively Recruiting

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Research Team

J

Josh Rudnicki

CONTACT

R

Richard Macko, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Ankle Robotics After Stroke | DecenTrialz