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Testing of a soft exoskeleton during locomotion tasks related to daily-life; XoSoft Gamma-prototype testing

Testing of a soft exoskeleton during locomotion tasks related to daily-life; XoSoft Gamma-prototype testing - XoSoft gamma-prototype testing

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48537
Enrollment
10
Registered
2018-07-18
Start date
2018-10-29
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebrovascular accident (CVA)

Interventions

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 ord

Sponsors

Roessingh Research & Development
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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 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

MeasureTime frame
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 users*s experience.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)