EXOPULSE database for routine follow-up of balance, muscle function, and chronic pain
The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes
This registry will try the EXOPULSE Mollii and EXOPULSE suits to see if they improve balance, muscle relaxation, local circulation, and chronic pain for people with cerebral palsy, multiple sclerosis, stroke, fibromyalgia, or other neurologic conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Exoneural Network AB Industry-sponsored |
| Locations | 1 site (Bergshamra, Stockholm County) |
| Trial ID | NCT05901259 on ClinicalTrials.gov |
What this trial studies
This is an observational registry collecting standardized clinical data before, during, and after use of the EXOPULSE Mollii Suit and EXOPULSE Suit in people with CP, MS, stroke, fibromyalgia and related neurologic disorders. Participants serve as their own controls and the primary outcome is change in the Berg Balance Scale or Pediatric Balance Scale, with additional measures of muscle activation, relaxation, local blood flow, and chronic pain. Investigators are trained and certified in the EXOPULSE method and apply standardized stimulation settings based on age and impairment to reduce variability; assessments are unblinded because the stimulation is usually perceptible. Routine re-assessments are conducted at scheduled visits by multiple investigators to help identify high responders within diagnostic subgroups.
Who should consider this trial
Good fit: Ideal candidates are people aged 2 years or older with cerebral palsy, multiple sclerosis (diagnosed >6 months), stroke (diagnosed >6 months), fibromyalgia (diagnosed >1 month), or other neurologic disorders causing similar symptoms, who can give informed consent and follow instructions and who meet the device size and safety criteria.
Not a fit: Patients with device contraindications, recent botulinum toxin treatment (<3 months), recent medication changes affecting neuromuscular activity, extreme body sizes outside the device limits, or inability to attend on-site assessments are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the suits could reduce muscle stiffness and chronic pain, improve balance, and lower fall risk, leading to better daily function.
How similar studies have performed: Smaller case series and pilot studies of Mollii-style wearable electrical stimulation have reported improvements in spasticity, pain, and function, but robust randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with CP, MS, stroke, fibromyalgia or other neurologic disorder that may cause such type of symptoms. * Diagnosed \>6 months prior to inclusion in case of MS or stroke as well as \>1 month prior to inclusion in the case of fibromyalgia. * Give written informed consent * Cognitively able to understand and follow verbal and/or written instructions * A minimum age of 2 years Exclusion Criteria: * Any of the contraindications listed in the instructions for use of the EXOPULSE Mollii Suit or EXOPULSE Suit * Being introduced to any new medication affecting the neuromuscular activity during the study period * Using botulinum toxin \<3 month before or during the study period * Subjects \<100 cm and \<13 kg * Subjects \>205 cm and \>115 kg
Where this trial is running
Bergshamra, Stockholm County
- Ottobock Care Sverige — Bergshamra, Stockholm County, Sweden (Recruiting)
Study contacts
- Principal investigator: Milana Mileusnic, PhD — Otto Bock Healthcare Products GmbH
- Study coordinator: Milana Mileusnic, PhD
- Email: milana.mileusnic@ottobock.com
- Phone: +43 6648415079
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.