Testing a soft exoskeleton during daily walking tasks; XoSoft Gamma prototype testing

Authors
Category Primary study
Registry of TrialsNetherlands Trial Register
Year 2018
INTERVENTION: Subjects will be measured while wearing the prototype and the system is activated (Active prototype) and while wearing the prototype and the system is in inactive state (InActive prototype). The order will be randomized. In the Active status the Gamma‐prototype can provide support to the lower limb(s). The system can support a total of three joints (hip, knee and ankle) per side in both directions (flexion/extension), in any combination. Subjects will perform locomotion‐tasks related to daily life. This includes sit‐to‐stand/stand‐to‐sit, walking in straight line, turning and walking curves, tested using the 10m walking test, L‐test and 8‐figure walk test. Furthermore, a daily‐life task in a living‐room like environment will be performed. In a previous visit the 10m walking test, L‐test and 8‐figure walk test will be performed without wearing the system. Wearable sensors will be used to measure the locomotion pattern without wearing the device. CONDITION: Stroke, Ischemic stroke, Spinal cord lesion ; ; PRIMARY OUTCOME: The feasibility of the system is tested by objective qualitative and quantitative evaluation of the gait pattern data, comparing the system in Active and InActive state with the locomotion pattern without wearing the system.; ; ; ; Kinematics (hip/knee/ankle angles, foot clearance, trunk kinematics) spatiotemporal (walking speed, duration of gait phases) and control‐strategy parameters (amount, timing, duration, consistency of the actuation) are evaluated. SECONDARY OUTCOME: The usability of the system is tested by subjective evaluation of the opinion of participants that used the prototype. The System Usability Scale and a semi‐structured interview will be used to gather information about user‐experience. INCLUSION CRITERIA: ‐stroke or incomplete spinal cord, at least 6 months ago ‐unilateral ( for stroke) or uni‐ or bilateral (for iSCI) impaired ‐able to walk without physical help of another person, walking aids are allowed (Functional Ambulation Categories score 3 or higher) ‐age 18 years or older ‐problems concerning walking with respect to foot clearance during swing and/or stability during stance phase ‐able to read and understand questionnaires and able to execute commands ‐able and willing to participate in the study ‐signed inform consent
Epistemonikos ID: 5dc94924e0c4310020c84a7b7a03f93a8bf0477e
First added on: Aug 25, 2024