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About
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.
Full 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.
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Inclusion criteria
Exclusion criteria
Diagnosis of neurological injury other than SCI including:
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
Primary purpose
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Interventional model
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19 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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