Myosuit in Incomplete Spinal Cord Injury

Launched by SINT MAARTENSKLINIEK · Nov 2, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a device called the Myosuit, which is a lightweight soft exosuit designed to help people with incomplete spinal cord injuries walk better. The trial aims to see how well the Myosuit works in real-life settings, like at home or in the community, for individuals who have been living with their injury for at least six months. To be eligible for this study, participants must be at least 18 years old, have some ability to stand and walk without assistance (though they can use devices like walkers), and have some hand function to put the Myosuit on and take it off.

Participants in the trial can expect to wear the Myosuit while walking to see if it helps improve their walking distance and speed. The study is open to people of all genders aged between 18 and 74, but those with certain medical conditions or specific physical limitations may not be eligible. This trial is currently recruiting participants, so if you or someone you know meets the criteria, it could be a great opportunity to help advance treatment options for spinal cord injuries.

Gender

ALL

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 included
• Exclusion 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 language
• • Psychiatric 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.