G80.1
Conditions
Interventions
Group 1: Children and asdolescents (age: 6-17) with a bilateral spastic CP and a GMFCS Level I, II or III receive 12 treatment sessions of frNMS plus physical therapy with a focus on motor learning ad
Sponsors
LMU Klinikum, Dr. von Haunersches Kinderspital, Abteilung für Pädiatrische Neurologie, Entwicklungsneurologie, Sozialpädiatrie und LMU Zentrum für Entwicklung und komplex chronisch kranke Kinder - iSPZ Hauner
Eligibility
Sex/Gender
All
Age
6 Years to 17 Years
Inclusion criteria
Inclusion criteria: - Diagnosis of bilateral spastic CP, GMFCS Level I, II or III - Age between 6 17 years - Insufficient hip and knee extension during standing and/or walking, classified on a clinical basis
Exclusion criteria
Exclusion criteria: - Hipflexion contraction >15° - Treatment with Botulinumtoxin or orthopedic operation of the lower extremity within the past three months - Contraindication for a treatment with magnetic stimulation • Confirmed epilepsy • Ferromagnetic (metal) parts in or on the body (e.g. piercings, intrauterine spiral, vascular clamps) • Biomedical implanted shunt-systems (e.g. ventriculo-peritoneal shunt) • Biomedical implanted devices (e.g. cochlear implant, medication pump, heart or brain pacemaker) • Pregnancy - Confirmed intellectual disability, defined by IQ < 70 - Confirmed attention deficit disorder (F90-F98, ICD 10)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| How many patients took part in at least eleven out of twelve scheduled session for functional rNMS over the three weeks intervention period (adherence rate)? Concerning adherence, the following supplementary questions will be addressed: -What are the reasons for discontinuation of treatment or for skipping more than one of the scheduled sessions of functional rNMS? -Are there any considerations for patients or their caregivers, who participated in the study, not to recommend functional rNMS to other patients/families? | — |
Secondary
| Measure | Time frame |
|---|---|
| - Recruiting rate: Proportion of eligible patients, who agree to participate in the study. - Clinical effects (ICF activity & participation): Comparison on an individual basis of clinical meaningful outcome parameters collected during a baseline and follow-up assessment. - Posture related effects (ICF structure & function): Comparison on an individual basis of parameters concerning postural control during instrumented posturography. - Gait related effects (ICF structure & function): Comparison on an individual basis of parameters concerning gait quality, muscle recruitment and functional aspects collected during 3D-gait analysis at a baseline and follow-up assessment. - Muscular effects (ICF structure): Comparison on an individual basis of ultrasound studies collected during a baseline and follow-up assessment. - Safety: Documentation of any adverse events (AEs) occurring during the intervention period by customized questionnaires for therapists, patients and caregivers (e.g. asking for pain, discomfort, headache, nausea). - Satisfaction: Assessment of the patients’ and caregivers’ overall satisfaction with the intervention, their motivation to continue treatment and their attitude towards recommending rNMS to other patients and families by a customized questionnaire. - Feasibility from the therapist’s perspective: Assessment of practicability and attitude towards the interventions by a customized questionnaire. | — |
Countries
Germany
Contacts
Public ContactMichaela Bonfert
LMU Klinikum, Dr. von Haunersches Kinderspital, Abteilung für Pädiatrische Neurologie, Entwicklungsneurologie, Sozialpädiatrie und LMU Zentrum für Entwicklung und komplex chronisch kranke Kinder - iSPZ Hauner
Outcome results
None listed