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The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes

Recruitingn/aAges 2 Years - anyAllOtto Bock Healthcare Products GmbH
NCT05901259 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The objective is to explore the potential short and long-term impact of the EXOPULSE Mollii Suit and EXOPULSE Suit on subjects with CP, MS, stroke, fibromyalgia or other neurologic disorders which may cause such types of symptoms, and to identify high responders among the sub-categories of the diagnoses. The primary endpoint will be improvements in the Berg/Pediatric Balance Scale (BBS/PBS) as a measurement of balance and risk of falls.

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📋 Eligibility rules (as published)
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
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What it tests

  • EXOPULSE Mollii Suit and EXOPULSE Suit
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Where

1 site
Ottobock Care Sverige
Bergshamra, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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