Primary objective is to evaluate the performance attributes and user progression of participants with motor complete and incomplete SCI while utilizing the Ekso robotic exoskeleton in an eight week over ground, locomotor program. Secondary objective…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Spinal cord injury (SCI) results in complete or partial loss of motor, sensory
and autonomic function, often leading to the use of a wheelchair and/or limited
or impaired ambulation. There are numerous complication due to the SCI and as a
result of impaired mobility and decreased weight bearing. The use of robotic
devices to promote walking ability may enhance the rehabilitation process by
providing more tools to achieve goals of increased functional mobility,
specifically ambulation, and may counteract some of the systemic impacts of
immobility and diminished weight bearing. One such devise is the Ekso
exoskeleton. Investigation of the role of robotic devices in the rehabilitation
setting in terms participant selection, user progression and performance
attributes is important for current devices and for future development. In
other words, what is the role of this potential *tool* for current and future
use.
Study objective
Primary objective is to evaluate the performance attributes and user
progression of participants with motor complete and incomplete SCI while
utilizing the Ekso robotic exoskeleton in an eight week over ground, locomotor
program. Secondary objective of the study is to monitor physical functioning
prior to the training and after the training.
Study design
European observational multicentre study on the feasibility of a robotic
exoskeleton.
Intervention
24 training sessions with an robotic exoskeleton device (Ekso exoskeleton)
during an eight week training period.
Study burden and risks
Participants will undergo two screening sessions, 24 training sessions with the
Eksoskeleton over an eight week training period, with a final assessment for
follow-up at week 12. The total number of visits is 27 over approximately 12-13
weeks. Each visit takes 60 to 90 minutes.
The risks are minimized by restrictive inclusion criteria, obtaining physician
clearance prior to study enrolment and by involving licensed physical
therapists (PTs) in the training sessions. For the purposes of this protocol,
Ekso will only be utilized in rehabilitation settings on solid, dry, level
(less than 2 percent slope) surfaces in areas reserved for rehabilitation
therapy. All transfers to and from the Ekso must also occur in these areas as
well. In addition, participants will initially use Ekso with the assistance of
two certified Ekso therapists. The level of assistance provided will be
decreased as deemed appropriate by the PT.
Relweg 51
Wijk aan Zee 1949 EC
NL
Relweg 51
Wijk aan Zee 1949 EC
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48523.029.14 |