Paralysis Paraplegia
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - SCI classification ASIA A or B, - Level of SCI between T1 and L1, - Age >= 18 years, - Good arm and hand function (ability to use crutches), - Can extend the legs almost complete (ROM knee 90/5/0, ROM hip 90/0/0) - Can independently make a transfer from a chair to a wheelchair (use of slide is not needed).
Exclusion criteria
Exclusion criteria: The main exclusion criteria are: - Severe spasticity (Modified Ashworth Scale> 3), - Taller than 1.90 and smaller than 1.60 meter, - Bodyweight of more than 100 kg, - Insufficient time to train - Other interfering conditions (CVA or insufficient mastery of the Dutch language).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameters are: 1) The number of skills a patient is able to perform after a training period of eight weeks, 2) The percentage of participants who can use the exoskeleton at home (after a training period of eight weeks) and 3) The amount of use of the exoskeleton during the patients home use (derived from diaries and number of steps taken by the exoskeleton). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters are: 4) Patient*s experience and 5) Health parameters; - Spasticity, - Bladder and bowel function - (Neuropathic) pain, - Range of motion (ankle and knee), - Quality of life and - Body experience. | — |
Countries
Netherlands