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TREAT Foot Drop After Stroke With Ankle Robot

NCT04137809 · NextStep Robotics Inc. · Updated 11 Sept 2020

What is being tested
AMBLE
For
Foot Drop; Stroke; Hemiparesis
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 21 years to 75 years. The full rules are on the registry page.
Where
United States
When
Starts or started April 2020, ends Aug 2020. Registered 24 Oct 2019.
Results
None posted yet.

In the researchers' words

Researchers at the University of Maryland Rehabilitation and Orthopaedic Institute are looking for individuals who have suffered a stroke and have leg and ankle weakness (foot-drop), to participate in a pilot study to examine the safety and effectiveness of an ankle robot walking program on walking function This is the first in human test of walking training over-ground using a wearable, lightweight, battery operated ankle robot exoskeleton; with assistance by trained research personnel for safety. This exercise device is aimed at assisting the foot during walking to reduce foot drop and improve walking safety in chronic, mild to moderately impaired stroke survivors who have foot drop. Possible risks of participating in this study are described in this document. The greatest risks include the risk of falling, muscle soreness, skin irritation, or cardiovascular complications. Before starting, you will have a medical history and medical assessments performed to determine if this study is safe for you. All sessions will be assisted by trained research personnel under supervision of a physical therapist, with medical personnel locally on call.
ClinicalTrials.gov, NCT04137809

Sites

  • UM Rehabilitation & Orthopaedic InstituteBaltimore, Maryland, United States