The primary goal of this research project is to study physiological responses of typically developing (TD) children and children with CP (only if the results of TD children are promising) to discomfort induced by the use of technological devices…
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is level of discomfort, measured with the CAPTIV
system (see paragraph 8.3 of the protocol). Respiration rate, 3D movement,
electrodermal activity, skin temperature, and heart rate will be determined,
which will serve as input for a discomfort recognition algorithm to measure the
level of discomfort.
Secondary outcome
The Visual Analog Scale will be used to indicate the amount of discomfort
during the experiments.
Background summary
During the last years, many new technologies have been developed for children*s
rehabilitation, such as treadmills in combination with a virtual environment,
robotics, and exoskeletons. Interventions using these technological devices can
improve walking function, endurance, and gross motor function in children with
Cerebral Palsy (CP) and induce a more intensive and task-specific exercise,
which can improve the engagement of children. However, the technological
devices may also cause discomfort in children, because they are not used to
these forms of therapy and it may cause pain, fear, unpleasant feelings or
friction of parts of the technological devices to the body. Until now, mostly
subjective measurement instruments are used to measure discomfort during
children*s rehabilitation. However, many children with CP also have cognitive
problems. Therefore, it can be difficult to complete the questions and to
express discomfort. Physiological parameters, such as heart rate, blood
pressure, and respiratory rate are altered during discomfort or stressful
situations. Some tests exist to generate discomfort in adults population during
for example free speech in front of an audience or while keeping a hand in cold
water (Trier Social Stress Test, Mental Arithmetic Stress Test, Socially
Evaluated Cold Pressor Test). However, these tests are not adapted to children
and are performed while subjects are seated and standing still while these
parameters are affected by physical activity. Measuring physiological
parameters during training situations can be integrated into the new
rehabilitation technologies by use of smart garments. In this way, it is easy
to use during training with a minimal impact on children.
Study objective
The primary goal of this research project is to study physiological responses
of typically developing (TD) children and children with CP (only if the results
of TD children are promising) to discomfort induced by the use of technological
devices during walking. The obtained data will be also used to develop a
discomfort recognition algorithm.
Study design
Experimental study
Study burden and risks
Children have to visit the Sint Maartenskliniek only once for 1.5 or 2 hours,
dependent on whether they have CP or are typically developing. We expect the
experiments to cause some discomfort as this is the goal of the experiments.
However, all situations will be controlled and are safe. In the experiment with
Charlie*s Plank, a therapist/researcher with experience in assisting patients
in virtual reality will assist the child and take care he/she won*t hurt
him/herself. In the experiment on the GRAIL, all children will wear a harness
and cannot fall on the treadmill. All experiments can be terminated at any time
when the child feels too uncomfortable or the child/parent is not willing to
continue for any other reason.
The current study is group related, as it is expected that children behave
differently from adults when placed in a situation that might cause discomfort.
Therefore, we cannot use the results of experiments in adults to make
assumptions about physiological reactions caused by discomfort in children.
Consequently, this study can only be done using this patient group of children.
Children will have no benefits from participating in this study.
Hengstdal 3
Ubbergen 6574 NA
NL
Hengstdal 3
Ubbergen 6574 NA
NL
Listed location countries
Age
Inclusion criteria
Typically Developing (TD) children:
- Aged 12 to 14 years old
Children with Cerebral Palsy (CP) (only if the results of TD children are
promising):
- Aged 12 to 14 years old
- Diagnosis of CP
- GMFCS level I or II
Exclusion criteria
TD children:
- Motor problems indicated by parents
- Visual problems not corrected by glasses
- Conditions that influence walking ability (such as a sprained ankle or
growing pains)
- Epilepsy
- Experience with walking on a treadmill
Children with CP:
- Visual or cardiovascular problems
- Temporary complaints influencing walking (such as a sprained ankle or growing
pains)
- Epilepsy
- Experience with walking on a treadmill
Design
Recruitment
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 | NL74870.091.20 |