This project has the following objectives: 1) to determine the effect of vertical, horizontal and mediolateral supportive forces of the RYSEN on gait parameters and muscle activity in able bodied individuals and patients; 2) determine theā¦
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cerebrovasculair accident en dwarslaesie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Experiment A & B
- Walking speed in m/s
- Step frequency in steps/s
- Step length in m
- Step width in m
- Margins of stability in m
- Muscle activity of eight muscles of the lower limb in microvolts
- Acceleration of pelvis, thigh and shank in m/s2
- Score on a purpose-made questionnaire about comfort and safety during walking
Experiment C
- Number of steps taken during training
- Net heart rate and predicted percentage of heart rate reserve
- Variability in trunk acceleration
- Rating of perceived exertion (RPE) (Borg, 1982)
- Walking trajectory during RYSEN(AR)-training
- Training goals set by physiotherapists
- Score on fear of falling and conscious movement processing questionnaires
(Ellmers et al., 2021)
- Score on a purpose-made questionnaire about training experiences
- Score on System Usability Scale (Finstad, 2006)
Experiment D
- Input during focus group meetings
Secondary outcome
Not applicable.
Background summary
Many patients with neurological impairments, such as a stroke or spinal cord
injury, show abnormal gait. This can lead to loss of indepence and mobility and
may reduce quality of life. In order to increase participation, rehabilitation
programs focus on improving gait.
It has frequently been shown that gait training is most effective when
performed on high intensity including many repetitions of task-specific
exercises. However, this is often not possible to achieve in current
rehabilitation as certain levels of muscle strenght, coordination and physical
fitness are thought to be required. Therefore, rehabilitation centres search
for innovative solutions, such as the RYSEN, in order to organize intensive,
task-specific training. The RYSEN is a 3D body weight support device that
allows patients that are unable to bear their body weight to start walking
early during rehabilitation. The RYSEN contains many applications that allow
for task-specific training. However, currently therapisist subjectively
determine the use of the RYSEN and its specific applications based on visual
inspection of the gait pattern. In this project, it will be investigated how
RYSEN applications can be used for specific training goals. Moreover, it will
be investigated how the RYSEN contributes to rehabilitation programs in order
to create specific guidelines for RYSEN use in clinical practice.
Study objective
This project has the following objectives: 1) to determine the effect of
vertical, horizontal and mediolateral supportive forces of the RYSEN on gait
parameters and muscle activity in able bodied individuals and patients; 2)
determine the differences in training content and intensity between
RYSEN(AR)-training and conventional physiotherapy; 3) determine experiences and
expectations of patients and therapists regarding RYSEN-training using
questionnaires and focus groups.
Study design
This project exists of four experiments (A until D), which will be executed
from May 2022 until June 2025. Experiment A and B are cross-sectional studies
about the effect of RYSEN-applications (vertical, horizontal and mediolateral
support) on step parameters and muscle activity in healthy individuals
(Experiment A) and patients (Experiment B). Experiment C will be an
observational cross-sectional study in which training content, intensity and
experiences will be compared between RYSEN(AR)-training and conventional
physiotherapy. Experiment D will be a qualitative study that assesses training
experiences and expectations in patients and therapists.
Intervention
In Experiments A & B, participants will perform experimental sessions in the
RYSEN during which different RYSEN applications (vertical, horizontal and
mediolateral support) will be applied. Participants will walk in the RYSEN in
these different conditions and simultaneously step parameters and muscle
activity will be measured.
In Experiment C, participants will perform three types of gait training within
the same week; RYSEN-training, RYSENAR-training and conventional physiotherapy.
Each training session will take 30 minutes and will be executed by supervision
of a physiotherapist.
In Experiment D, focus groups will be organised in which experiences and
expectations about RYSEN training will be assessed in patients and therapists.
Study burden and risks
Experiments A and B will have a duration of 1.5 hours. During these
experiments, step parameters and muscle activity will be measured using a
movement registration system (Optotrak) and electromyography.
In Experiment C, participants will perform three types of training as part of
their usual rehabilitation program. Training sessions will take 30 minutes and
will be supervised by a physiotherapist. During training, heart rate,
acceleration of the trunk and the number of steps taken will be assessed using
a heart frequency watch and inertial measurement units. After each training,
participants will be asked to fill in questionnaires, this will take about 30
minutes.
In Experiment D, participants will attend a focus group meeting for about 1.5-2
hours.
Relweg 51
Wijk aan Zee 1949 EC
NL
Relweg 51
Wijk aan Zee 1949 EC
NL
Listed location countries
Age
Inclusion criteria
General inclusion criteria:
- Age >= 18 years
- Weight <= 135 kilograms
- Length <= 2 meters
- Able to provide informed consent and understand Dutch instructions
Only applicable for people after stroke:
- Suffered a first or recurrent stroke, as diagnosed by a neurologist
- Receives rehabilitation treatment care in Heliomare
- Time since stroke between 7 days and 6 months at time of inclusion (Bernhardt
et al., 2017)
- Functional Ambulation Category (FAC) 2 or higher, indicating the patient is
able to perform balancing and coordinating tasks with or without some
assistance
- Medication that influences motor control does not alter during participation
- Received at least one RYSEN-training before participation in this study
Only applicable for people after SCI:
- Having a traumatic or non-traumatic SCI with motor incomplete (AIS C and D)
as determined by ISNCSCI
- Receives rehabilitation treatment care in Heliomare
- Medication that influences motor control does not alter during participation
- Being able to stand with a standing aid
- Having MRC 3 or higher in hip muscles and quadriceps
- Received at least one RYSEN-training before participation in this study
Exclusion criteria
- Having vestibular disease
- Having visual impairments
- Having contractures or skin lesions in the lower extremities that interfere
with application of the RYSEN
- Pregnancy
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 | NL80828.042.22 |