The ReWalk Exoskeletal Walking System for Persons With Paraplegia

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

The ReWalk Exoskeletal Walking System for Persons With Paraplegia

Official Title

The ReWalk Exoskeletal Walking System for Persons With Paraplegia

Brief Summary

      It is well appreciated that an extreme sedentary lifestyle from paralysis, contributes to
      many secondary medical problems such as diabetes and insulin resistance, obesity,
      constipation, poor blood pressure regulation, cardiovascular disease, reduced quality of
      life, and more. The ReWalk-I exoskeleton walking device permits investigation of the
      potential benefits of frequent upright posture and walking on many of the secondary
      consequences of spinal cord injury. The researchers are investigating the ability of persons
      with paraplegia to learn to stand and walk with the ReWalk-I and the effects of being upright
      and walking on several of these secondary medical consequences of spinal cord injury.
    

Detailed Description

      Potential participants will be pre-screened with the inclusion criteria for eligibility. The
      informed consent process will begin for those participants who have been determined to meet
      the inclusion criteria. After the potential participant's signed consent has been provided,
      further evaluations for eligibility will be performed (e.g., there are several medical and
      physical exclusion criteria). Those potential participants who meet both the inclusion and
      exclusion criteria will be eligible to enroll into the ReWalk-I study. Baseline evaluations
      and personalized measurements for fitting to the ReWalk-I will be performed over one week,
      before the training sessions begin. The ReWalk sessions will consist of a Learning Phase (12
      sessions in 4 weeks) and a Training Phase (18 sessions in 6 weeks). These times may vary by
      each participant's ReWalk learning curve. Training will begin with sit-to-stand,
      stand-to-sit, and standing balance activities. Progression to walking will occur as skills
      advance. Each session will be an average 50 minutes, with 3 sessions per week. The skills to
      be learned include 1) sit-to-stand, 2) stand-to-sit, 3) 2-arm standing balance, 4) 1-arm
      standing balance, 5) walking, and 6) stair climbing. The study evaluations will be repeated
      after the Learning Phase, after the Training Phase and 1-month post training follow-up.
    


Study Type

Interventional


Primary Outcome

Count to Achieve Mobility Skills


Condition

Paraplegia

Intervention

powered exoskeleton

Study Arms / Comparison Groups

 Powered Exoskeleton
Description:  persons with SCI trained to use a powered exoskeleton to ambulate overground

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

19

Start Date

February 2011

Completion Date

August 8, 2015

Primary Completion Date

August 8, 2015

Eligibility Criteria

        Inclusion Criteria:

          1. Males or females with paraplegia

          2. Duration of SCI >6 months

          3. Ages 18 to 65 y

          4. Height 160 to 190cm (63-75in or 5'3" to 6'3")

          5. Weight <100kg (<220 lb)

          6. Ability to give informed consent

        Exclusion Criteria:

          1. Diagnosis of neurological injury other than SCI including:

               -  Multiple sclerosis (MS)

               -  Stroke

               -  Cerebral Palsy (CP)

               -  Amyotrophic lateral sclerosis (ALS)

               -  Traumatic Brain injury (TBI)

               -  Spina bifida

               -  Parkinson's disease (PD)

               -  Other neurological condition that the study physician considers in his/her
                  clinical judgment to be exclusionary

          2. Severe concurrent medical disease, illness or condition

          3. Recent lower extremity fracture within the past 2 years;

          4. DXA results indicating a t-score below -3.0 and knee BMD <0.70 gm/cm2

          5. Systemic or peripheral infection

          6. Atherosclerosis, congestive heart failure, or history of myocardial infarction

          7. Trunk and/or lower extremity pressure ulcers;

          8. Other illness, that the study physician considers in his/her clinical judgment to be
             exclusionary

          9. Severe spasticity (defined by an Ashworth score of >4.0 or clinical impression of the
             study physician or physical therapist)

         10. Significant contractures defined as flexion contracture limited to 35º at the hip and
             20º at the knee;

         11. Diagnosis of heterotrophic ossification of the lower extremities;

         12. Femoral neck or the total proximal femur bone mineral density T-scores < -3.0

         13. Psychopathology documentation in the medical record or history of that may conflict
             with study objectives

         14. Hypertension (SBP>140, DBP>90)

         15. Pregnancy and/or lactating females
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Ann M Spungen, EdD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01454570

Organization ID

JJPVAMC: SPU-09-11

Secondary IDs

Protocol#: SPU-09-11

Responsible Party

Principal Investigator

Study Sponsor

James J. Peters Veterans Affairs Medical Center


Study Sponsor

Ann M Spungen, EdD, Principal Investigator, Bronx JJPVAMC CoE 7A-13


Verification Date

August 2020