MedTrace Logo

Spinal Cord Injury Leg Rehabilitation

NCT01498991 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-05-24

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine if individuals with incomplete spinal cord injury (SCI) who remain unable to walk normally 1 year after their SCIs are able to sense and move the affected legs better after 10-13 weeks of treatment with a new robotic therapy device.

The hypothesis is that using the AMES device on the legs of chronic subjects with incomplete SCI will result in improved strength, sensation in the legs, and improved functional gait in the treated limbs.

Conditions

  • Spinal Cord Injury
  • Paraplegia
  • Quadriplegia
  • Tetraplegia

Interventions

DEVICE

AMES Treatment

The AMES device rotates the ankle over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that move the leg. Each participant will receive treatment of both lower extremities. Treatment of the 2 legs will be scheduled to run in the same session. The subject's task is to assist the motion of the device. The AMES treatment device couples assisted movement and tendon vibration (enhanced sensation) in 30 treatments which will each run approximately 40 minutes (20 minutes on the right leg and 20 minutes on the left leg).

Sponsors & Collaborators

  • Shepherd Center, Atlanta GA

    collaborator OTHER

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Paul J Cordo, PhD · Oregon Health and Science University

  • Andrew Nemecek, MD · Oregon Health and Science University

  • Deborah Backus, PT, PhD · Shepherd Center, Atlanta GA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT01498991 on ClinicalTrials.gov