MOTION (Mechanised Orthosis for Children with Neurological Disorders): Physiological responses to discomfort induced by the use of technological rehabilitation devices in childre

• Conditions: Children with Cerebral Palsy (and Typically Developing children)

• Registration Number: NL-OMON29609
• Lead Sponsor: Sint Maartenskliniek Nijmegen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.