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TREAT Foot Drop After Stroke With Ankle Robot

NCT04137809 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-09-11

No results posted yet for this study

Summary

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.

Conditions

  • Foot Drop
  • Stroke
  • Hemiparesis

Interventions

DEVICE

AMBLE

Treadmill walking while wearing AMBLE device; three times a week for two weeks; 45-60 minutes per session.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    collaborator OTHER

  • NextStep Robotics Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Macko, MD · University of Maryland, College Park

  • Bradley Hennessie, MHA,MBA · NextStep Robotics Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04137809 on ClinicalTrials.gov