Performance attributes and user progression while using Ekso Robotic Exoskeleton in an eight week, over ground, locomotor program in individuals with spinal cord injury

Completed

Conditions: paraplegia/tetraplegia
spinal cord injury
10041543

Registration Number: NL-OMON42049

Lead Sponsor: Heliomare

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 8

Inclusion Criteria

People with motor complete or motor incomplete SCI who are participating in inpatient or outpatient rehabilitation

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Performance attributes and user progression in terms of ability to complete an<br /><br>eight week training program and time frame to achieve an increased level of<br /><br>independence in activities:<br /><br>* The number of Ekso sessions completed<br /><br>* Number of steps in device<br /><br>* Time spent walking in device<br /><br>* Number of training sessions in each mode<br /><br>* Change over time in terms of level of assistance from personnel, assistive<br /><br>device utilized, and locomotor ability while ambulating in the Ekso device </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The following assessments will be completed to address secondary outcome<br /><br>parameters:<br /><br>* Cardiovascular impact<br /><br>* Perceived rate of exertion (PRE)<br /><br>* Bowel function<br /><br>* Bladder function<br /><br>* Quality of life<br /><br>* Functional abilities<br /><br>* Pain<br /><br>* Spasticity<br /><br>* Strength<br /><br>* Walking ability (if applicable)<br /><br><br /><br>* Energy expenditure<br /><br>* Muscle activity</p><br>