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

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ClinicalTrials.gov Identifier: NCT01454570
Recruitment Status : Unknown
Verified April 2015 by Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center.
Recruitment status was:  Recruiting
First Posted : October 19, 2011
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):
Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center

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:
  1. Sit-to-stand,
  2. Stand-to-sit,
  3. Standing balance for 1 minutes with both crutches,
  4. Standing balance for 30 seconds with one crutch,
  5. Ten meter walk in ≤2 minutes,
  6. Walk ≥30 meters in 6-minutes, and
  7. 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:
  1. Sit-to-stand,
  2. Stand-to-sit,
  3. Standing balance for 1 minutes with both crutches,
  4. Standing balance for 30 seconds with one crutch,
  5. Ten meter walk in ≤2 minutes,
  6. Walk ≥30 meters in 6-minutes, and
  7. 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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified 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
  1. Do you have paraplegia?
  2. Is your SCI greater than 6 months?
  3. Are you between the ages of 18 to 65y?
  4. Is your height between 63 and 75 inches?
  5. Do you weigh less than 220 pounds?
  6. 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:

  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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older 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