G81.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: o Hemiparesis as a result of congenital or acquired brain damage (ICD-10 G81.1) o The cause of the brain injury was more than 1 year ago o Gross Motor Function Classification System (GMFCS) Level I to III o Manual Ability Classification System (MACS) Level I to III o Communication Function Classification System (CFCS) Level I to II o Written declaration of consent from the patient and legal guardian
Exclusion criteria
Exclusion criteria: o Intellectual disability (IQ < 70) o Untreated attention deficit (hyperactivity) syndrome (AD(H)S) o Uncontrolled epilepsy - BUT: controlled epilepsy is not an exclusion criterion. Controlled epilepsy means that the patient has been seizure-free for =24 months (with or without antiepileptic drug therapy) o Contraindication for MRI imaging, or neurostimulation: - Implanted biomedical shunt systems (e.g. ventriculo-peritoneal shunt) - Implanted biomedical devices (e.g. cochlear implant, drug pump, heart or brain pacemaker) - Implanted ferromagnetic material - Pregnancy - Skin irritation, inflammatory skin disease in the area of the extremity to be treated (for neurostimulation) - Claustrophobia (for MRI examination)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| How does the performance of self-selected everyday activities defined before the start of the intensive measure and satisfaction with the performance of these everyday activities change as assessed by the Canadian Occupational Performance Measure (COPM) interview with video analysis at time T1 compared to time T0? | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. How does the performance of self-selected everyday activities defined before the start of the intensive intervention or the control phase and the satisfaction with the performance of these everyday activities change as assessed by the Canadian Occupational Performance Measure (COPM) interview at T2 and T3 compared to T0 and T5 at T4 and in comparison between the intervention and control phases? 2. How does the subjective functional ability in everyday activities with both hands change as measured by the Children's Hand Experience Questionnaire (CHEQ) at T2 and T3 in comparison to T0 and T5 to T4 and in comparison between the intervention and control phases? 3. How does the burden of disease change due to the limitations in everyday activities with both hands assessed using the Children's Hand Experience Questionnaire (CHEQ) at time points T2 and T3 compared to time points T0 and T5 to T4 and comparing the intervention phase to the control phase? 4. How does self-esteem change as measured by the self-esteem statement list for children and adolescents (ALS) at T2 and T3 compared to T0 and T5 to T4 and comparing the intervention phase to the control phase? 5. How does the behavior/behavior-related symptoms assessed using the Youth Self Report (YSR) and Child Behavior Checklist (CBCL) change at T2 and T3 in comparison to T0 and T5 to T4 and in comparison to the intervention and control phase? 6. How does the health-related quality of life of the affected children change as assessed by the questionnaire for the assessment of health-related quality of life in children and adolescents in the revised form (KINDL-R) at time T3 compared to time T0 or T5 to T4 and in comparison of the intervention phase to the control phase? 7. How does the stress experienced by parents and siblings due to the child's illness change as measured by the family stress questionnaire (FaBel questionnaire) at time T3 compared to time T0 or T5 to T4 and in comparison of the intervention pha | — |
Countries
Germany
Contacts
LMU Klinikum, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital, Abteilung für Pädiatrische Neurologie, Entwicklungsneurologie und Sozialpädiatrie