Using Myosuit to help people with incomplete spinal cord injuries walk better
Efficacy of the Myosuit for Increasing Daily Life Gait Performance in the Home and Community Setting and Gait Capacity in People With Incomplete Spinal Cord Injury
This study is testing if a special lightweight suit can help people with partial spinal cord injuries walk better in their daily lives.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sint Maartenskliniek Academic / other |
| Locations | 1 site (Ubbergen) |
| Trial ID | NCT05605912 on ClinicalTrials.gov |
What this trial studies
This study evaluates the Myosuit, a lightweight soft exosuit designed to assist individuals with incomplete spinal cord injuries (iSCI) during walking. It aims to improve daily life gait performance in home and community settings by providing support to those with voluntary control of their leg muscles. The study includes a randomized controlled trial to assess the efficacy of the Myosuit compared to a control group, focusing on enhancing gait capacity and overall mobility. Participants will be monitored for improvements in walking speed and distance over the course of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stable chronic incomplete spinal cord injuries and sufficient hand function to use the Myosuit.
Not a fit: Patients with complete spinal cord injuries or those unable to walk independently may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance mobility and quality of life for patients with incomplete spinal cord injuries.
How similar studies have performed: Previous studies have shown promising results with similar exosuit technologies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ubbergen
- Sint Maartenskliniek — Ubbergen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Bart van den Bemt — Sint Maartenskliniek
- Study coordinator: Lara Visch
- Email: la.visch@maartenskliniek.nl
- Phone: 024-3272701
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.