The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes
Recruiting · NCT05901259 · Observational (researchers observe without assigning treatment) · Lead sponsor: Exoneural Network AB
View the official record on ClinicalTrials.gov →Interventions studied
EXOPULSE Mollii Suit and EXOPULSE Suit
What this trial is about
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.
Who can take part
Age range
2 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
2 locations listed.
- Ottobock Care Sverige - Bergshamra, Stockholm County, Sweden
- Ottobock Care Sverige - Bergshamra, Stockholm County, Sweden