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, the efficacy of the Myosuit program on gait capacity…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
People with incomplete spinal cord injury (iSCI) show often impairments and
limitations related to walking dysfunction. Therefore, a common primary goal of
people with iSCI is improvement of gait. Despite all the effort put in
regaining gait capacity by training, gait and standing capacity and ambulation
in home and community setting of many people with iSCI remain limited. As a
consequence of limited gait capacity, these people are likely to develop a
sedentary lifestyle resulting in a vicious circle of walking impairments, which
negatively affects daily life gait performance and quality of life. One of the
options with a high potential to improve gait capacity and daily life gait
performance is the use of assistive technology. Powered exoskeletons
compensate for the loss of strength, however, exoskeletons are heavy and take
over the entire control of the lower limbs. Patients with iSCI who have
residual mobility do not take advantage of heavy exoskeletons. Light-weighted
exosuits provide assistance during walking and patients do have a voluntary
contribution of the leg muscles. A recently introduced lower extremity soft
exosuit is the Myosuit (MyoSwiss AG). In a small sample study, participants
showed an increased gait speed when using the Myosuit compared to their
baseline gait speed. Moreover, a small number of training sessions was required
for use in the home and community setting. In this study the efficacy of the
Myosuit for increasing daily life gait performance in the home and community
setting in people with iSCI will be tested. Furthermore, we will evaluate the
effect of wearing the Myosuit on gait capacity.
Study objective
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, 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.
Part B:
The primary objective is to investigate differences in gait capacity with and
without wearing the Myosuit by conducting clinical tests. Secondary,
differences in gait capacity measured on an instrumented treadmill with motion
capture system, the GRAIL, with and without wearing the Myosuit will be
examined.
Study design
Randomized controlled trial.
Intervention
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 control group will receive a program of
regular physiotherapy and a personalized regular training program for at home.
Part B: Participants perform clinical tests and measurements on an instrumented
treadmill with and without the Myosuit.
Study burden and risks
There are no serious risks associated with participation in this study.
Clinical tests which will be performed in context of this study, are already
conducted in clinical care. Participants will wear a safety harness during
measurements on the GRAIL. For safe use of the Myosuit participants receive a
training program from certified physiotherapists. Furthermore, where possible,
a caregiver will attend minimal one Myosuit training session in order to assist
the patient in the home and community setting. Participants receive the Myosuit
at their disposal at home when they are able to use the Myosuit independently.
If a participant have any questions about the use of the Myosuit he/she can
contact by phone the researcher/physiotherapist for advice.
Hengstdal 3
Ubbergen 6574NA
NL
Hengstdal 3
Ubbergen 6574NA
NL
Listed location countries
Age
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<5).
- 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 walking function.
- For the second objective of the second part 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 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80641.091.22 |