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Exopulse Mollii Suit, Motor Functions & CP Children With Cerebral Palsy
Sponsor: Exoneural Network AB
Summary
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.
Official title: The Effects of EXOPULSE Mollii Suit on Motor Functions in Children With Cerebral Palsy (EXOCEP 2 GER)
Key Details
Gender
All
Age Range
5 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2023-04-17
Completion Date
2025-12-31
Last Updated
2026-08-05
Healthy Volunteers
No
Interventions
Exopulse Mollii Suit
Exopulse Mollii suits consists of a body Garments (Jacket and Pants) and a control unit. The body Garments (Jacket and Pants) is a suit with 58 embedded electrodes that can stimulate 40 groups of muscles, conductive wires and connectors to a detachable control unit, whose intended purpose is to transmit electric pulses from the control unit to key nerves and corresponding muscle groups throughout the body. The control unit is a battery powered electrical device which sends low intensity electric pulses through connectors to the Body Garments which in turn transmits the pulses from the connectors to key nerves and corresponding muscle groups throughout the body.
Sham Exopulse Mollii Suit
In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.
Locations (2)
Pohlig GmbH
Traunstein, Bavaria, Germany
Medizinische Hochschule Hannover (MHH)
Hanover, Germany