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Recruiting NCT05901259

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

Trial Parameters

Condition Cerebral Palsy
Sponsor Exoneural Network AB
Study Type OBSERVATIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 2 Years
Max Age N/A
Start Date 2026-02-18
Completion 2027-08-01
Interventions
EXOPULSE Mollii Suit and EXOPULSE Suit

Brief Summary

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.

Eligibility 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

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