The primary goal of this research is to test the proof of concept of the functional prototype of the INES exoskeleton for children with CP in the clinic. In addition,the defined use cases (Donning, Doffing, Sit-to-stand, Stand to sit, Walk) will be…
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is usability that will be measured with the System
Usability Scale (Dutch version).
Secondary outcome
In addition, performance of the defined use cases (Donning, Doffing,
Sit-to-stand, Stand-to-sit, Walk) will be described and evaluated.
Background summary
Cerebral palsy is one of the most common disabilities in childhood. Cerebral
palsy is a permanent non-progressive disease, but the symptoms may become more
severe over time and the impact on daily live as well. Children often
experience limitations in gait and self-mobility which are associated with a
lower quality of life score regarding their physical wellbeing. Robotic devices
has been developed ror gait training and support during daily life for adults.
However these are not suitabel for children with cerebral palsy. Therefore the
aim of the MOTION project was to develop an exoskeleton(INES) for children with
neurological disorders (in particular children with cerebral palsy)to improve
quality of life.
Study objective
The primary goal of this research is to test the proof of concept of the
functional prototype of the INES exoskeleton for children with CP in the
clinic. In addition,the defined use cases (Donning, Doffing, Sit-to-stand,
Stand to sit, Walk) will be evaluated.
Study design
Explorative/feasibility study
Intervention
Exploratieve/feasibility studie to evaluate the functional prototype of the
INES exoskeleton.
Study burden and risks
All participants have to visit the Sint Maartenskliniek twice for 2 hours. We
expect that the tests may cause some discomfort, since the participants are not
used to walk in an exoskeleton. In addition it must be noted that he INES
exoskeleton is a functional prototype tested in an clinical environment for the
first time during development. However, all situations will be controlled and
are safe. For balance control, participants are allowed to use assistive
devices. In addition, tests will be performed in a robotic body-weight support
system on an overhead track that allow practicing activities without the risk
of falling. Furthermore, a physical therapist and technician with experiences
in robotic devices will assist during the session. All experiments can be
terminated at any time the participants feels too uncomfortable or the
participant/parent is not willing to continue for any other reason.
The current study is group related, as the exoskeleton is developed for
children with neurological disorders (for example cerebral palsy). Since
children with neurological disorders are the target group, the exoskeleton
should be tested in these children with walking problems such as muscle
weakness, coordination impairment, spasticity and bone deformations. Since we
will test the functional prototype of the INES exoskeleton in the clinic for
the first time, the exoskeleton will be tested in (small) healthy young
adults, before we will start testing with young adults with CP.
Hengstdal 3
Nijmegen 6522 JV
NL
Hengstdal 3
Nijmegen 6522 JV
NL
Listed location countries
Age
Inclusion criteria
1) Healthy (young) adults (n=4)
-Age > 16 years old
-Weight 20-55 kg
-Height 1.34-1.60 m
-No conditions that affects walking ability
-No cognitive problems
2) Young adults with cerebral palsy (n=4)
-Age >16 years old
-Bilateral cerebral palsy
-GMFCS II-IV
-Weight 20-55 kg
-Height 1.34-1.60 m
-No severe cognitive problems
-No severe spasticity
-No severe limited range of motion in ankle, knee and hip joints.
-No severe bone deformations
Exclusion criteria
-Temporary complaints affecting walking (such as a sprained ankle)
- (Little) wounds on body parts that are in contact with the exoskeleton
-Severe secondary health conditions ( such as cardiovascular problems)
Design
Recruitment
Medical products/devices used
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In other registers
Register | ID |
---|---|
CCMO | NL84127.000.23 |