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

NCT05901259

RecruitingN/A

Sponsor: Exoneural Network AB

Conditions: Cerebral Palsy, Multiple Sclerosis, Stroke, Neurologic Disorder, Fibromyalgia

Interventions: EXOPULSE Mollii Suit and EXOPULSE Suit

Countries: Sweden

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 overview

Sex: ALL

Age: 2 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

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
Locations (1)
  • Bergshamra, Stockholm County, Sweden