Clinical trial NCT01454570: The ReWalk Exoskeletal Walking System for Persons With Paraplegia
Official title: The ReWalk Exoskeletal Walking System for Persons With Paraplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paraplegia
Keywords: exoskeleton walking system
paraplegia
paralysis
Lead sponsor: James J. Peters Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2011-10-19
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Count to Achieve Mobility Skills
timeFrame: ReWalk training at 4 and 12 weeks, and 1-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: James J. Peters Veterans Affairs Medical Center; Center of Excellence for the Major Consequences of SCI.
state: New York
Study officials:
affiliation: Bronx JJPVAMC CoE 7A-13
name: Ann M Spungen, EdD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsai CY, Asselin PK, Hong E, Knezevic S, Kornfeld SD, Harel NY, Spungen AM. Exoskeletal-assisted walking may improve seated balance in persons with chronic spinal cord injury: a pilot study. Spinal Cord Ser Cases. 2021 Mar 12;7(1):20. doi: 10.1038/s41394-021-00384-8.
citation: Asselin P, Cirnigliaro CM, Kornfeld S, Knezevic S, Lackow R, Elliott M, Bauman WA, Spungen AM. Effect of Exoskeletal-Assisted Walking on Soft Tissue Body Composition in Persons With Spinal Cord Injury. Arch Phys Med Rehabil. 2021 Feb;102(2):196-202. doi: 10.1016/j.apmr.2020.07.018. Epub 2020 Nov 7.
citation: 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.