Testing of a soft exoskeleton during locomotion tasks related to daily-life; XoSoft Gamma-prototype testing
- Conditions
- cerebrovascular accident (CVA)incomplete spinal cord injury (iSCI)stroke10007963
- Registration Number
- NL-OMON48537
- Lead Sponsor
- Roessingh Research & Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Stroke:
- Stroke in the personal history, at least 6 months ago
- Unilateral impairment
- Able to walk without physical help of another person, walking aids are allowed (Functional Ambulation Category (FAC) score * 3
- age *18 years
- problems concerning walking with respect to foot clearance in swing and/or stability in stance
- Able to read and understand questionnaires and able to execute commands
- Able and willing to participate in the study
- Signed Informed Consent
Incomplete spinal cord:
- Incomplete spinal cord injury in the personal history, at least 6 months ago
- Unilateral or bilateral impairment
- Able to walk without physical help of another person, walking aids are allowed (Functional Ambulation Category (FAC) score * 3
- age *18 years
- problems concerning walking with respect to foot clearance in swing and/or stability in stance
- Able to read and understand questionnaires and able to execute commands
- Able and willing to participate in the study
- Signed Informed Consent
Stroke and incomplete spinal cord injury:
- Inability to wear the prototype due to health conditions (like wounds that can give a problem when wearing the system)
- in case ankle-foot orthoses are used in daily life: inability to walk without ankle-foot orthosis for 10m
- Severely impaired sensation of the lower limb
- Amputations or other musculoskeletal problems influencing locomotion
- Other neurological diseases or cardiopulmonary diseases influencing locomotion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The feasibility of the system is tested by objective qualitative and<br /><br>quantitative evaluation of the gait pattern data, comparing the system in<br /><br>Active and Inactive state with the locomotion pattern without wearing the<br /><br>system.<br /><br><br /><br>Kinematics (hip/knee/ankle angels, foot clearance, trunk kinematics),<br /><br>spatiotemporal (walking speed, duration of gait phases) and control-strategy<br /><br>parameters (amount, timing, duration, consistency of the actuation) are<br /><br>evaluated.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The usability of the system is tested by subjective evaluation of the opinion<br /><br>of participants that used the prototype. The System Usability Scale and a<br /><br>semi-structured interview will be used to gather information about users*s<br /><br>experience.</p><br>