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Testen van een zacht exoskelet tijdens looptaken uit het dagelijks leven; XoSoft Gamma-prototype testen


- candidate number29468
- NTR NumberNTR7450
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-aug-2018
- Secondary IDsNL65466.044.18 METC Twente Enschede 
- Public TitleTesten van een zacht exoskelet tijdens looptaken uit het dagelijks leven; XoSoft Gamma-prototype testen
- Scientific TitleTesting of a soft exoskeleton during locomotion tasks related to daily-life; XoSoft Gamma-prototype testing
- ACRONYMXoSoft gamma-prototype testing
- hypothesisThe objective of this proof-of-concept study is to test the feasibility of the gamma-prototype of the lower limb exoskeleton XoSoft during locomotion-tasks related to daily life in stroke and incomplete spinal cord injury patients in a controlled environment.
- Healt Condition(s) or Problem(s) studiedStroke, Ischemic stroke, Spinal cord lesion
- 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
- Exclusion criteria-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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2018
- planned closingdate31-jan-2019
- Target number of participants10
- InterventionsSubjects 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.
- Primary outcomeThe 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 outcomeThe 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.
- Timepoints3 visits are planned: one to fit and adapt the textile garment, 1 to attach all the hardware modules to the garment and 1 to perform measurements with the Active and InActive prototype
- Trial web sitewww.xosoft.eu
- statusplanned
- CONTACT FOR PUBLIC QUERIES Corien Nikamp
- CONTACT for SCIENTIFIC QUERIES Corien Nikamp
- Sponsor/Initiator Roessingh Research and Development, Roessingh Research and Development performs the trial in collaboration with the other partners within the European H2020 XoSoft project.
- Funding
(Source(s) of Monetary or Material Support)
European Union, Horizon 2020 framework programme for research and innovation H2020-ICT-2015 grant agreement No 688175
- Publications
- Brief summary
- Main changes (audit trail)Rationale: Various types of exoskeletons were developed in the last decade to assist people with mobility impairments. Most of the existing exoskeletons have a rigid structure, heavy weight and a bulky design, which limits the use during activities of daily living and in the home environment. Therefore, a new project called XoSoft was conducted, to develop a soft lower-limb exoskeleton to assist people with mobility problems. XoSoft aims for a flexible and lightweight structure requiring low power consumption.
Objective: 1) To test the feasibility of using the Gamma-prototype of lower-limb exoskeleton XoSoft during locomotion-tasks related to daily life in stroke and incomplete spinal cord injury (iSCI) patients; 2) To test the usability of the Gamma-prototype during locomotion-tasks related to daily life in stroke and iSCI patients.
Study design: A pilot study, planned as an open, randomized proof of concept study. All measurements are performed in a controlled environment. The subjectís normal locomotion pattern (without wearing the system) will be compared with the locomotion pattern while wearing the XoSoft system.
Study population: Maximal 10 medically stable subjects, at least 6 months after stroke or iSCI will be recruited. Subjects are ≥18 years of age and able to walk without physical help of another person (walking aids are allowed). Subject have problems during walking with respect to foot clearance in swing and/or stability in stance.
Intervention: First, the subjects locomotion pattern will be measured without wearing the system Inertial sensors will be used, while performing the 10m walking test, L-test and 8-figure walk test. Subsequently, 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 state 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, depending on the needs of the subject. 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.
Main study parameters/endpoints: Kinematics (hip/knee/ankle angels, 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, 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 usersí experience.
- RECORD28-aug-2018 - 15-sep-2018


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