Feasibility of exoskeleton training for home use for patient with motor complete spinal cord injury.

Completed

Conditions: Paralysis
Paraplegia
10041543

Registration Number: NL-OMON42978

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

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

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).

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome parameters are:<br /><br>1) The number of skills a patient is able to perform after a training period of<br /><br>eight weeks,<br /><br>2) The percentage of participants who can use the exoskeleton at home (after a<br /><br>training period of eight weeks) and<br /><br>3) The amount of use of the exoskeleton during the patients home use (derived<br /><br>from diaries and number of steps taken by the exoskeleton).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters are:<br /><br>4) Patient*s experience and<br /><br>5) Health parameters;<br /><br>- Spasticity,<br /><br>- Bladder and bowel function<br /><br>- (Neuropathic) pain,<br /><br>- Range of motion (ankle and knee),<br /><br>- Quality of life and<br /><br>- Body experience.</p><br>