EXOPULSE database for routine follow-up of balance, muscle function, and chronic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.