Multiparametric investigation of the effects of the Magic Moves intervention at the clinical, muscular and central level

Not Applicable

• Conditions: G81.1; Spastic hemiplegia

• Registration Number: DRKS00034444
• Lead Sponsor: MU Klinikum, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital, Abteilung für Pädiatrische Neurologie, Entwicklungsneurologie und Sozialpädiatrie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 15

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

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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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?