Spinal Cord Injury Leg Rehabilitation

Learn more about:
Related Clinical Trial
Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury Retraining Walking After Spinal Cord Injury Spinal Cord Injury Exercise and Nutrition Conceptual Engagement Body Composition Assessment in Spinal Cord Injury Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study Medico-economical Impact of the Brindley Neurosurgical Technique in France Evaluation of Safety and Performance of the Atalante System With Patients With Lower Limb Paralysis The Safety of ahSC in Chronic SCI With Rehabilitation Evaluation of an Advanced Lower Extremity Neuroprostheses Natural History of Shoulder Pathology in Manual Wheelchair Users Correlation Between Pressure Differences and Micro-vascularization Changes in Bedridden Paraplegic Patient Quantification of the Pressure Threshold Related to Tissue Injury in Bedriden Paraplegics Functional Electrical Stimulation With Rowing as Exercise After Spinal Cord Injury Spinal Cord Injury Leg Rehabilitation Multimodal Exercises to Improve Leg Function After Spinal Cord Injury A Neuroprosthesis for Prolonged Standing After SCI Using Multi-Contact Peripheral Nerve Electrodes A Neuroprosthesis for Seated Posture and Balance Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI) Functional Electrical Stimulation Cycling in SCI Exoskeletal-assisted Walking to Improve Mobility, Bowel Function and Cardio-Metabolic Profiles in Persons With SCI Study of the Impact of the Use of a Corset on the Respiratory Function of Patients With Spinal Cord Injury Exercise to Reduce Obesity in Spinal Cord Injury Interactive Telehealth for Wheelchair Users The Feasibility and Effects of Low-load Blood-flow Restricted Exercise Following Spinal Cord Injury Evaluation of a Power Assistance Device for Wheelchair-DUO Assessment of Vasomotion of People With Spinal Cord Injury Adjusting Wheelchair Set-Up to Minimize Shoulder Joint Forces During Propulsion ExoAtlet II For SCI Patients Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis (RGO) Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via the Tongue. Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit High-intensity Interval Training for Cardiometabolic Health in Persons With Spinal Cord Injury High-intensity Interval Training and Mixed Meal Responses in Persons With Spinal Cord Injury The ReWalk Exoskeletal Walking System for Persons With Paraplegia Gait Training for Individuals With Paraplegia Using the H-MEX Exoskeleton Training With Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion for Patients With Chronic Complete Paraplegia Evaluation of a Hybrid Prototype Strategy (Electrostimulation of Lower Limb Muscles Associated With Voluntary Strengthening of the Upper Limbs) in Reconditioning to Effort in Patients With Chronic Paraplegia.

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

Interventional


Primary Outcome

Gait Velocity

Secondary Outcome

 Vibration Threshold Test

Condition

Spinal Cord Injury

Intervention

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.

Publications

* 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

Device

Estimated Enrollment

2

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
             level

          -  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
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Paul J Cordo, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01498991

Organization ID

IRB00007762

Secondary IDs

R01NS061304-22

Responsible Party

Principal Investigator

Study Sponsor

Oregon Health and Science University

Collaborators

 Shepherd Center, Atlanta GA

Study Sponsor

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


Verification Date

May 2019