Severe motor and intellectual disabilities
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Children with a score of multiple and severely handicapped children of 25 or more. 2) Children who need treatment of tracheotomy or artificial respirator. 3) Children who are 17 years old or younger. 4) Children with lower body weight than 20 kg. 5) Children whose consent for participation in this study is provided by the representative.
Exclusion criteria
Exclusion criteria: 1) Children for whom the principal investigator or other investigators decided not suitable for participation in this study. 2) Children who became multiple and severely handicapped due to traumas of traffic injury, etc.. 3) Children who need sustained continuous suction. 4) Children with a history of bone fracture within 3 years until the time of registration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| High-Frequency (HF) components by frequency analysis of heart rate variability. | — |
Secondary
| Measure | Time frame |
|---|---|
| Low-Frequency (LF)/HF components by frequency analysis of heart rate variability, activity value of salivary amylase, incidence rate of adverse event, appearance change (in facial expression, body movements). | — |
Countries
Japan
Contacts
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders Educational Therapy