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ID
Source
Brief title
Health condition
Children with Cerebral Palsy (and Typically Developing children)
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures are the physiological parameters, measured with the CAPTIV system. The CAPTIV system measures respiration rate, 3D movement, electrodermal activity, skin temperature, and heart rate. Based on the measurements, an algorithm will be developed to assess the level of discomfort.
Secondary outcome
The Visual Analog Scale will be used to indicate the amount of discomfort during the experiments. At baseline, descriptive data as age, gender, length, and weight will be collected. In children with CP, data as GMFCS level, type of CP (spastic, dyskinetic, or ataxic) and localisation (uni or bilateral) will be collected. In addition, the questionnaire “Vragenlijst voor Angst bij Kinderen” (VAK) completed by parents and child before the start of the experiment (Oosterlaan et al. 1995) to determine trait anxiety.
Background summary
Rationale: 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 stress 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.
Objective: The primary goal of this research project is to study physiological responses of typically developing (TD) children and children with CP to discomfort induced by the use of technological devices. The obtained data will be also used to develop a discomfort recognition algorithm.
Study design: Experimental study
Study population: Typically developing children (n=6) and, if the results of TD children are promising, children with Cerebral Palsy (n=6) will be included as well, all aged 12 to 14 years.
Main study parameters/endpoints: The primary outcome measures are the physiological parameters, measured with the CAPTIV system including respiration rate, 3D movement, electrodermal activity, skin temperature, and heart rate, which will serve as input for a discomfort recognition algorithm to measure the level of discomfort.
Study objective
We will be able to develop a discomfort recognition algorithm for 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.
Study design
Data will be collected on one time point.
Inclusion criteria
TD children:
- Aged 12 to 14 years old
Children with 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
- 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
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9130 |
| Other | CMO Regio Arnhem-Nijmegen : 2020-6869 |