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Recruiting NCT05605912

Myosuit in Incomplete Spinal Cord Injury

Conditions: Incomplete Spinal Cord Injury

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 34
Sponsor: Sint Maartenskliniek

Location: Netherlands

Summary

The Myosuit is a light-weighted lower extremity soft exosuit which provide assistance during walking. In this study the Myosuit will be tested in the home and community setting in patients with incomplete spinal cord injury.

Eligibility Criteria

Inclusion Criteria:People with a stable chronic iSCI (>6 months after injury).Having an injury level of C or D on the American Spinal Injury Association Impairment Scale.Age ≥ 18 years.Need to have sufficient hand function and standing balance to don and doff the Myosuit or they need a caregiver who is available to help the participant to use the Myosuit at home.Having reduced gait capacity due to reduced knee and/or hip strength (MRC=<4).Must be able to stand up from a chair without deviating to the left or right side for more than 45 degrees during the movement.Can walk for 10 meter without the assistance of another person but can be assisted by assistive devices except knee orthoses.People aim to improve walking distance, walking speed or gait capacity.Sufficient postural control to walk independently (i.e. without assistance of a person, assistive devices are allowed).For the second objective of part B of this study, only people who are be able to walk consecutively for two minutes on a treadmill without any assistive device and without using the handrails will be includedExclusion Criteria:Have another (neurological) disease which can influence motor performance.Have wounds which can be worsened by wearing the Myosuit will be excluded.Taller than 195 and smaller than 150 cm.Body weight of more than 110 kg or less than 45 kg.Pregnancy.Insufficient mastery of the Dutch languagePsychiatric background.Flexion contracture in knee or hip in excess of 10 degrees.Knee varus malposition in excess of 10 degrees or knee valgus malposition in excess of 10 degrees.Oncological spinal cord injury.Unsuitable for participation according to the rehabilitation physician or researcher.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05605912). StuddyBuddy aggregates publicly available trial information.