Spinal Cord Injury Leg Rehabilitation

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Brief Title

Spinal Cord Injury Leg Rehabilitation

Official Title

Rehabilitation of the Lower Extremity With AMES Following Incomplete Spinal Cord Injury (SCI)

Brief 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.

Detailed Description

      Traumatic spinal cord injury (SCI) affects over 200,000 people in the USA, with several
      thousand new injuries each year. Most recovery, following SCI, occurs in the six months
      following surgery. Further recovery after 12 months is unusual.

      In this study 10 subjects, more than 1 year post injury, will be enrolled to test the safety
      and efficacy of a new type of robotic therapy device known as the AMES device. The aim of
      this Phase I/II study is to investigate the use of assisted movement and enhanced sensation
      (AMES) technology in the rehabilitation of the legs of participants with incomplete SCI.

Study Phase

Phase 1/Phase 2

Study Type


Primary Outcome

Gait Velocity

Secondary Outcome

 Vibration Threshold Test


Spinal Cord Injury


AMES Treatment

Study Arms / Comparison Groups

 AMES Treatment
Description:  The subject will receive 30 treatment sessions, conducted 3-4 times per week on the AMES device. Each session will consist of testing followed by 40 minutes of treatment time (20 minutes per each leg) using the AMES device.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

November 2011

Completion Date

November 2016

Primary Completion Date

November 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Paraplegia or tetraplegia due to SCI

          -  At least 1 year post incomplete Spinal Cord Injury

          -  Can tolerate sitting upright for at least one hour

          -  Capable of weight-bearing and taking a step with or without an assistive device

          -  On the ASIA sensory function (light touch), a score of at least 1 at the L4 and L5

          -  Primary ASIA Motor Criterion (PAMC) a total score of 4-12 for hip extensors, knee
             extensors, ankle dorsiflexors and ankle plantarflexors, with a minimum score of 1 for
             each of these muscles in the qualifying leg

        Exclusion Criteria:

          -  Fracture of the treated limb resulting in loss of range of motion

          -  Concomitant TBI or stroke (Patients who sustained mild head injury during the trauma
             with no evidence of structural abnormalities on brain images will qualify for the
             study), or other neurological injury or disease

          -  DVT of the treated extremity

          -  Peripheral nerve injury of the treated extremity

          -  Osteo- or rheumatoid-arthritis limiting range of motion

          -  Contractures equal to or greater than 50% of the normal ROM

          -  Skin condition not tolerant of device or sitting upright

          -  Progressive neurodegenerative disorder

          -  Botox treatment of the treated extremity in the prior 5 month

          -  Chronic ITB therapy

          -  Uncontrolled seizure disorder

          -  Uncontrolled high blood pressure/angina

          -  Pain in affected limb or exercise intolerance

          -  Participation in another therapy or activity-based program

          -  Combined score on ASIA motor function for knee extensors, ankle dorsiflexors and ankle
             plantarflexors outside the range of 3-9




18 Years - 65 Years

Accepts Healthy Volunteers



Paul J Cordo, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party

Principal Investigator

Study Sponsor

Oregon Health and Science University


 Shepherd Center, Atlanta GA

Study Sponsor

Paul J Cordo, PhD, Study Director, Oregon Health and Science University

Verification Date

May 2019