Spinal cord injury tetraplegia
Conditions
Interventions
Part A: The intervention group will receive training sessions with the Myosuit
at the Sint Maartenskliniek. Thereafter, they will receive the Myosuit at their
disposal at home for six weeks. The con
Sponsors
Sint Maartenskliniek
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - People with 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 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
Exclusion criteria
Exclusion criteria: - Have another (neurological) disease which can influence motor performance. - Have small 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. - Flexion contracture in knee or hip in excess of 10 degrees. - Varus malposition in excess of 10 degrees or valgus malposition in excess of 10 degrees.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: The primary objective is to test the efficacy of the Myosuit, a soft exosuit, for increasing daily life gait performance in the home and community setting in people with iSCI. The main study parameter is the number of minutes walking per day. Secondary, the efficacy of the Myosuit program on gait capacity and its cost-effectiveness based on this RCT will be investigated. Finally, the usability of the Myosuit for use in home and community setting will be evaluated. For gait capacity the primary study parameter is the 10 meter walk test (10MWT) at preferred walking speed. The System Usability Scale (SUS) is the primary study parameter for usability. For cost-effectiveness quality-adjusted-life years (QALY) gain and costs will be measured. Part B: The primary objective is to investigate differences in gait capacity with wearing the Myosuit compared to without wearing the Myosuit by conducting clinical tests. The primary study parameter for gait capacity is the 10MWT at preferred walking speed. Secondary, differences in gait capacity measured on the GRAIL with and without wearing the Myosuit will be examined. The tripartite model described by Balasubramanian and colleagues will be taken as starting point. In this model, gait capacity consists of three components: stepping, dynamic balance and gait adaptability. The main study parameters are: preferred walking speed, margin of stability and precision stepping for respectively stepping, dynamic balance and gait adaptability. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: The primary objective is to test the efficacy of the Myosuit, a soft exosuit, for increasing daily life gait performance in the home and community setting in people with iSCI. Secondary study parameters are: activity intensity, length and number of gait bouts, maximal covered distance, mean and variability in spatiotemporal gait parameters, margin of stability, foot placement and Lyapunov exponent. Secondary, the efficacy of the Myosuit program on gait capacity and its cost-effectiveness based on this RCT will be investigated. Finally, the usability of the Myosuit for use in home and community setting will be evaluated. The secondary study parameters for gait capacity are the 10MWT at maximum walking speed, the 6 minute walk test (6MWT), the mini balance evaluation system test (Mini-BESTest), the walking index for spinal cord injury II (WISCI II) and the spinal cord injury functional ambulation profile (SCI-FAP), for measuring functional walking performance. The Dutch version of the quebec user evaluation of satisfaction with assistive technology (D-QUEST) is a secondary study parameter for usability. Part B: The primary objective is to investigate differences in gait capacity with wearing the Myosuit compared to without wearing the Myosuit by conducting clinical tests. Secondary study parameters for gait capacity are the 10MWT at maximum walking speed and the 6MWT. Secondary, differences in gait capacity measured on the GRAIL with and without wearing the Myosuit will be examined. Secondary study parameters are: step length, step-length symmetry, single-support time, single-support time symmetry, hip-knee-ankle kinematics, joint moments and peak joint powers for stepping and foot placement for dynamic balance. | — |
Countries
Netherlands
Outcome results
None listed