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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON29609

Enrollment

Registered

2020-12-16

Start date

2021-01-04

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children with Cerebral Palsy (and Typically Developing children)

Interventions

None listed

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Contacts

Public ContactRosanne Kuijpers

Sint Maartenskliniek

r.kuijpers@maartenskliniek.nl0031243528123

Outcome results