Using the EXOPULSE Mollii Suit to Help Children with Cerebral Palsy
The Effects of EXOPULSE Mollii Suit on Motor Functions in Children With Cerebral Palsy (EXOCEP): A Pilot Study
This study is testing if the EXOPULSE Mollii suit can help children with cerebral palsy relax their tight muscles and move better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 5 Years to 12 Years |
| Sex | All |
| Sponsor | Institut De La Colonne Vertebrale Et Des Neurosciences Academic / other |
| Locations | 4 sites (Aix-en-Provence and 3 other locations) |
| Trial ID | NCT06266286 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the EXOPULSE Mollii suit, a non-invasive device that applies transcutaneous electrostimulation to manage spasticity in children with cerebral palsy. The suit aims to relax spastic muscles, improve mobility, and enhance overall quality of life by providing a novel therapeutic approach. Participants will be assessed for their ability to walk and their level of spasticity, with the goal of determining the suit's impact on their motor functions and daily activities. The study will compare the active suit to a sham version to evaluate its true efficacy.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 to 12 years with a clinical diagnosis of unilateral or bilateral spastic cerebral palsy who can walk with slight limitations.
Not a fit: Patients who have contraindications to wearing the EXOPULSE Mollii suit or are currently involved in another research protocol 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 by providing a non-invasive treatment option for spasticity.
How similar studies have performed: Previous studies have shown some success with transcutaneous electrical nerve stimulation for spasticity management, but the EXOPULSE Mollii suit represents a novel application of this technology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 5 and 12 years. * Having a clinical diagnosis of unilateral or bilateral spastic cerebral palsy since at least one month. * Being able to walk freely, with slight limitation or using ancillary equipment's (Gross Motor Function Classification System (GMFCS) score ≤3). * Having a PBS score \< 45. * Being French speaker, able to understand verbal instructions, and affiliated to the national health insurance (sécurité sociale). * Having spasticity with a score of at least 1+ on the MAS Exclusion Criteria: * Being included in another research protocol during the study period * Being unable to undergo medical monitor for the study purposes due to geographical or social reasons * Having contraindications to wearing EXOPULSE Mollii suit (i.e., implanted electronic medical devices or equipments which can be disrupted by magnets including ventriculoperitoneal shunts and intrathecal baclofen pumps, electronic life support equipment or high-frequency operation equipment, as well as well electrocardiography equipment or cardiac stimulator) * Having a change in the pharmacological therapy over the last three months * Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain, skin diseases). * Suffering from a cutaneous disease * Using another medical device * Being part of other protected populations as defined in articles L. 1121-5, L. 1121 6,1121-8 and L. 1122-1-2 of the Public Health Code
Where this trial is running
Aix-en-Provence and 3 other locations
- Centre Hospitalier Intercommunal D'Aix Pertuis — Aix-en-Provence, France (Recruiting)
- Centre Medico Chirurgical de Readaptation Des Massues — Lyon, France (Not_yet_recruiting)
- Centre de Sante Rossetti — Nice, France (Recruiting)
- Centre de Readaptation Pediatrique D'Oleron — Saint-Trojan-les-Bains, France (Recruiting)
Study contacts
- Study coordinator: Samar S AYACHE, MD, PhD
- Email: samarayache@gmail.com
- Phone: 0149814662
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.