Physiological responses to discomfort induced by the use of technological rehabilitation devices in childre

Recruiting

• Conditions: Cerebral Palsy; 10029317

• Registration Number: NL-OMON49063
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 12

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is level of discomfort, measured with the CAPTIV<br /><br>system (see paragraph 8.3 of the protocol). Respiration rate, 3D movement,<br /><br>electrodermal activity, skin temperature, and heart rate will be determined,<br /><br>which will serve as input for a discomfort recognition algorithm to measure the<br /><br>level of discomfort.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The Visual Analog Scale will be used to indicate the amount of discomfort<br /><br>during the experiments. </p><br>