Status:
COMPLETED
The ReWalk Exoskeletal Walking System for Persons With Paraplegia
Lead Sponsor:
James J. Peters Veterans Affairs Medical Center
Conditions:
Paraplegia
Eligibility:
All Genders
18-65 years
Phase:
NA
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 pre...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2015
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01454570
Start Date
February 1 2011
End Date
August 8 2015
Last Update
August 25 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
James J. Peters Veterans Affairs Medical Center; Center of Excellence for the Major Consequences of SCI.
The Bronx, New York, United States, 10468