RecruitingNCT05901259

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


Sponsor

Exoneural Network AB

Enrollment

200 participants

Start Date

Feb 18, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 2 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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

Interventions

DEVICEEXOPULSE Mollii Suit and EXOPULSE Suit

The registry is designed to demonstrate the impact of EXOPULSE Mollii Suit or EXOPULSE Suit on muscle relaxation, muscle activation, local blood circulation and/or chronic pain relief. The subjects included use the suit for 60 minutes every other day, unless other is specified by the Investigator, in their home environment for up to a maximum of 2 consecutive weeks. Qualitative and quantitative measures will be collected at baseline (T0), after 60 minutes stimulation (T1), after 2 weeks of home use (T2) and during two additional phone calls 1-3 days after the first stimulation session (T1,5) as well as 4 weeks after the first stimulation session (T3).


Locations(1)

Ottobock Care Sverige

Bergshamra, Stockholm County, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05901259


Related Trials