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

Launched by EXONEURAL NETWORK AB · May 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the Exopulse Mollii Suit, a special wearable device designed to help children with Cerebral Palsy (CP). CP is a condition that affects movement and muscle control, often resulting in stiffness or weakness in the muscles. The trial aims to see if wearing this suit can improve balance, mobility, and overall quality of life for kids with CP, while also reducing muscle tightness (called spasticity) and pain.

To be eligible for the trial, children must be between 5 and 12 years old and diagnosed with either unilateral (affecting one side) or bilateral (affecting both sides) spastic CP. They should be able to walk, even if it’s with some difficulty or with support. Children must also be able to understand basic instructions in German. Participants will not be allowed to join if they have certain medical devices, other serious medical conditions, or have received specific treatments in the last few months. If eligible, children will get the chance to wear the Exopulse Mollii Suit and take part in activities that may help improve their movement and comfort. This trial is currently looking for participants, and it offers a promising opportunity for kids with CP to potentially benefit from new technology designed for their needs.

Gender

ALL

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