euromodulation by repetitive neuromuscular magnetic stimulation in children with central movement disorder - feasibility and acceptance of an innovative approach
- Conditions
- G80.2Spastic hemiplegic cerebral palsy
- Registration Number
- DRKS00022100
- Lead Sponsor
- Fachzentrum für Pädiatrische Neurologie, Neurorehabilitation und Epilepsie, Schön Klinik Vogtareuth
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 30
Congenital or acquired brain injury (> 12 months ago)
Cerebral Palsy GMFCS Level I or II or III
Age between 6 and 17 years
Dorsiflexor weakness (Medical Research Conucil Score < 4)
Spasticity of the plantarflexors (Tardieu Scale >1)
Admission for at least 3 week to the reabilitation clinic (inpatient setting)
Confirmed intellectual disability, defined by IQ < 70
Confirmed attention deficit disorder (F90-F98, ICD 10)
Severe impairment of communication (CFCS Level III, IV, V)
Treatment with Botulinumtoxin or orthopedic operation of the lower extremity within the past 3 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients that take part in at least 9 of 10 scheduled treamtent sessions.<br><br>Further questions adressing adherence rate: what are the reasons for discontinuation of treatment? What would be reasons to not recommend the treatment to other patients and their parents?
- Secondary Outcome Measures
Name Time Method Clincal effects: Evaluation on an individual basis in terms of clinical assessments during 4 timepoints.<br>Recruiting rate: Proportion of eligible paitents, that take part in the study<br>Safety: Reporting fo adverese events <br>Satisfaction: Are patients and parents satisfied with the treatment<br>Feasibility from the physiotherapist's perspective after the invertention period