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Exopulse Mollii Suit, Motor Functions & CP Children With Cerebral Palsy

CompletedNA

Sponsor: Exoneural Network AB

Conditions: Cerebral Palsy, Spasticity, Muscle, Pain Syndrome, Hemiplegia

Interventions: Exopulse Mollii Suit, Sham Exopulse Mollii Suit

Countries: Germany

Cerebral Palsy (CP) is is estimated to be around 1.5-3 per live birth, with prenatal factors accounting for 75% of cases. CP appears in early childhood and persists with age and is characterized by permanent lesions or abnormalities affecting the immature brain. It mainly occurs as a motor system disorder (e.g., abnormal movements or posture) with the presence of hemiplegia, diplegia or tetraplegia, and spastic, dyskinetic or atactic syndromes. .This study will explore the potential clinical benefits of the Molliimethod in children with cerebral palsy. Spasticity impacts balance and mobility, halts the patients quality of life and their ability to perform their activity of daily living, and could also increase the risk of fractures and falls. Available interventions that aim on improving spasticity are facing limitations such as varios side effects. Therefore, developing novel therapies such as the EXOPULSE Mollii Suit could help to overcome such limitations and noninvasively improve balance, mobility, quality of life and reduce spasticity and pain in children with CP.

Eligibility overview

Sex: ALL

Age: 5 Years to 12 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

Patients will be included if they

* are between 5 and 12 years of age.
* have a clinical diagnosis of unilateraal or bilateral spastic CP by birth \[15\].
* have a PBS score between a minimum of 15 and a maxmimum of 44 points.
* are able to walk freely, with slight limitation or using ancillary equipment's (GMFCS score ≤3) \[49\].
* are German speakers, able to understand verbal instructions.
* have spasticity with a score of at least 1+ on the MAS

Exclusion Criteria:

Patients will not be included if they

* are included in another research protocol during the study period.
* are unable to undergo clinical procedures for the study purposes due to geographical or social reasons.
* have a cardiac stimulator, a ventriculoperitoneal shunt, intrathecal baclofen pump.
* have a change in their pharmacological therapy over the last three months or are planning to do so during the study.
* suffer from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).
* have a body mass index above 35 kg/m2,
* have contraindications to wearing Exopulse Mollii Suit, receive a medical device other than Exopulse Mollii during the study period.
* have received botulinum toxin (botox) therapy in the last 3 months before the start of the study

Locations (2)

Traunstein, Bavaria, Germany
Hanover, Germany