Using the Exopulse Mollii Suit to improve motor functions in children with cerebral palsy
The Effects of EXOPULSE Mollii Suit on Motor Functions in Children With Cerebral Palsy (EXOCEP 2 GER)
NA · Exoneural Network AB · NCT05885139
This study tests if wearing the Exopulse Mollii Suit can help improve movement and balance in children aged 5 to 12 with spastic cerebral palsy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 5 Years to 12 Years |
| Sex | All |
| Sponsor | Exoneural Network AB (industry) |
| Locations | 2 sites (Traunstein, Bavaria and 1 other locations) |
| Trial ID | NCT05885139 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of the Exopulse Mollii Suit on motor functions in children aged 5 to 12 with spastic cerebral palsy. The intervention aims to noninvasively reduce spasticity and improve balance and mobility, which are often compromised in these patients. Participants will be assessed based on their ability to walk and their level of spasticity, with the study comparing the effects of the active suit against a sham version. The goal is to provide a novel therapeutic approach to enhance the quality of life for children suffering from this condition.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 to 12 with a clinical diagnosis of unilateral or bilateral spastic cerebral palsy who can walk with slight limitations.
Not a fit: Patients with other serious medical conditions or those currently involved in other research protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve mobility and quality of life for children with cerebral palsy.
How similar studies have performed: While there have been studies on neurostimulation and spasticity, the specific use of the Exopulse Mollii Suit represents a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Traunstein, Bavaria and 1 other locations
- Pohlig GmbH — Traunstein, Bavaria, Germany (RECRUITING)
- Medizinische Hochschule Hannover (MHH) — Hanover, Germany (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Palsy, Spasticity, Muscle, Pain Syndrome, Hemiplegia, Diplegia, Tetraplegia, Balance