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Recruiting
NCT05901259
The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes
Conditions: Cerebral Palsy, Multiple Sclerosis, Stroke, Neurologic Disorder, Fibromyalgia
Sex: All
Ages: 2 Years – N/A
Healthy volunteers: No
Enrollment: 200
Sponsor: Otto Bock Healthcare Products GmbH
Location: Ottobock Care Sverige Bergshamra Stockholm County
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 \
Source: ClinicalTrials.gov (NCT05901259). StuddyBuddy aggregates publicly available trial information.