paraplegia/tetraplegia spinal cord injury
Conditions
Interventions
24 training sessions with an robotic exoskeleton device (Ekso exoskeleton)
during an eight week training period.
Sponsors
Heliomare
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: People with motor complete or motor incomplete SCI who are participating in inpatient or outpatient rehabilitation
Exclusion criteria
Exclusion criteria: - Any medical issue that in the opinion of the Investigator precludes full weight bearing locomotor training. - Any medical issue that in the opinion of the Investigator would affect participant safety either due to cognitive deficits/impulsivity, intolerance to mild exercise or other factors. - Any issue that in the opinion of the Investigator would confound results such as a concurrent neurological injury or disorder (other than SCI) or other factors. - Skin integrity issues in areas that contact the device (including abdominal ostomies) or that would prohibit sitting. -Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Performance attributes and user progression in terms of ability to complete an eight week training program and time frame to achieve an increased level of independence in activities: * The number of Ekso sessions completed * Number of steps in device * Time spent walking in device * Number of training sessions in each mode * Change over time in terms of level of assistance from personnel, assistive device utilized, and locomotor ability while ambulating in the Ekso device | — |
Secondary
| Measure | Time frame |
|---|---|
| The following assessments will be completed to address secondary outcome parameters: * Cardiovascular impact * Perceived rate of exertion (PRE) * Bowel function * Bladder function * Quality of life * Functional abilities * Pain * Spasticity * Strength * Walking ability (if applicable) * Energy expenditure * Muscle activity | — |
Countries
Netherlands
Outcome results
None listed