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

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.

Conditions

• Cerebral Palsy
• Spasticity
• Muscle
• Pain Syndrome
• Hemiplegia
• Diplegia
• Tetraplegia
• Balance

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• Ottobock SE & Co. KGaA

  collaborator UNKNOWN

• Hannover Medical School

  collaborator OTHER

• Pohlig GmbH

  collaborator UNKNOWN

• Exoneural Network AB

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

5 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-17

Primary Completion

2024-06-30

Completion

2024-06-30

Countries

• Germany

Study Locations