euromodulation by repetitive neuromuscular magnetic stimulation (rNMS) applied to the gluteus muscles in bilateral spastic Cerebral Palsy – effects on activity, participation, body structure and function.
- Conditions
- G80.1Spastic diplegic cerebral palsy
- Registration Number
- DRKS00023766
- Lead Sponsor
- MU Klinikum, Dr. von Haunersches Kinderspital, Abteilung für Pädiatrische Neurologie, Entwicklungsneurologie, Sozialpädiatrie und LMU Zentrum für Entwicklung und komplex chronisch kranke Kinder - iSPZ Hauner
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 40
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
- 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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)? <br>Concerning adherence, the following supplementary questions will be addressed: <br>-What are the reasons for discontinuation of treatment or for skipping more than one of the scheduled sessions of functional rNMS? <br>-Are there any considerations for patients or their caregivers, who participated in the study, not to recommend functional rNMS to other patients/families? <br>
- Secondary Outcome Measures
Name Time Method