The ReWalk Exoskeletal Walking System for Persons With Paraplegia (VA_ReWalk)

Tracking Information
First Submitted Date	September 14, 2011
First Posted Date	October 19, 2011
Last Update Posted Date	April 10, 2015
Study Start Date	February 2011
Estimated Primary Completion Date	April 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: March 27, 2014)	Percent change from baseline [ Time Frame: ReWalk training at 4 and 12 weeks, and 1-month follow-up ]; 1. To determine efficacy for mobility defined as the ability to perform the following with the ReWalk-I exoskeletal system, without staff assistance: Sit-to-stand,; Stand-to-sit,; Standing balance for 1 minutes with both crutches,; Standing balance for 30 seconds with one crutch,; Ten meter walk in ≤2 minutes,; Walk ≥30 meters in 6-minutes, and; Ascend, turn around and descend 4 stairs in 5 minutes.
Original Primary Outcome Measures; (submitted: October 18, 2011)	Percent change from baseline [ Time Frame: ReWalk training at 4 and 12 weeks, and 16-week follow-up ]; 1. To determine efficacy for mobility defined as the ability to perform the following with the ReWalk-I exoskeletal system, without staff assistance: Sit-to-stand,; Stand-to-sit,; Standing balance for 1 minutes with both crutches,; Standing balance for 30 seconds with one crutch,; Ten meter walk in ≤2 minutes,; Walk ≥30 meters in 6-minutes, and; Ascend, turn around and descend 4 stairs in 5 minutes.
Change History	Complete list of historical versions of study NCT01454570 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: March 27, 2014)	Percent change from baseline [ Time Frame: ReWalk training at 4 and 16 weeks, and 1-month follow-up ]; Sitting and standing balance skills, bowel function, bladder function by survey, muscle spasms by survey, quality of life by survey, resting and exercise energy expenditure, body composition, and neurological tests. Additional mobility training will be observed for a timed-up-and-go (TUG) and a mild obstacle course (incline, decline, carpeting, step, simulated curb, walking in a figure 8)
Original Secondary Outcome Measures; (submitted: October 18, 2011)	Percent change from baseline [ Time Frame: ReWalk training at 4 and 16 weeks, and 16-week follow-up ]; Sitting and standing balance skills, bowel function, bladder function by survey, muscle spasms by survey, quality of life by survey, resting and exercise energy expenditure, body composition, and neurological tests. Additional mobility training will be observed for a timed-up-and-go (TUG) and a mild obstacle course (incline, decline, carpeting, step, simulated curb, walking in a figure 8)
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
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	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Do you have paraplegia?; Is your SCI greater than 6 months?; Are you between the ages of 18 to 65y?; Is your height between 63 and 75 inches?; Do you weigh less than 220 pounds?; Are you legally able to sign for your own consent? Persons who answer "no" to any of the above questions will not be eligible for the study
Condition	Paraplegia
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Asselin P, Knezevic S, Kornfeld S, Cirnigliaro C, Agranova-Breyter I, Bauman WA, Spungen AM. Heart rate and oxygen demand of powered exoskeleton-assisted walking in persons with paraplegia. J Rehabil Res Dev. 2015;52(2):147-58. doi: 10.1682/JRRD.2014.02.0060.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Unknown status
Estimated Enrollment; (submitted: October 18, 2011)	40
Original Estimated Enrollment	Same as current
Estimated Study Completion Date	November 2015
Estimated Primary Completion Date	April 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: Males or females with paraplegia; Duration of SCI >6 months; Ages 18 to 65 y; Height 160 to 190cm (63-75in or 5'3" to 6'3"); Weight <100kg (<220 lb); Ability to give informed consent Exclusion Criteria: 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; Severe concurrent medical disease, illness or condition; Recent lower extremity fracture within the past 2 years;; DXA results indicating a t-score below -3.0 and knee BMD <0.70 gm/cm2; Systemic or peripheral infection; Atherosclerosis, congestive heart failure, or history of myocardial infarction; Trunk and/or lower extremity pressure ulcers;; Other illness, that the study physician considers in his/her clinical judgment to be exclusionary; Severe spasticity (defined by an Ashworth score of >4.0 or clinical impression of the study physician or physical therapist); Significant contractures defined as flexion contracture limited to 35º at the hip and 20º at the knee;; Diagnosis of heterotrophic ossification of the lower extremities;; Femoral neck or the total proximal femur bone mineral density T-scores < -3.0; Psychopathology documentation in the medical record or history of that may conflict with study objectives; Hypertension (SBP>140, DBP>90); Pregnancy and/or lactating females
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT01454570
Other Study ID Numbers	JJPVAMC: SPU-09-11; Protocol#: SPU-09-11 ( Other Identifier: JamesJPetersVAMC )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center
Study Sponsor	James J. Peters Veterans Affairs Medical Center
Collaborators	Not Provided
Investigators	Principal Investigator: Ann M Spungen, EdD Bronx JJPVAMC CoE 7A-13
PRS Account	James J. Peters Veterans Affairs Medical Center
Verification Date	April 2015