RecruitingRecruiting
The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes
NCT05901259 · Exoneural Network AB
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
The observational study (also referred to as the 'registry') is designed to demonstrate the impact of EXOPULSE Mollii Suit and EXOPULSE Suit on relaxation of muscles, muscle activation, local blood circulation and chronic pain relief.
The subjects will serve as their own control and the data will be collected before, during and after the treatment period. As the electrical stimulation from the suit usually is above the level of sensation, the study participant will not be blinded to the treatment.
To prevent bias, multiple investigators will be collecting the data and only standardized and validated methods will be used. All investigators will be trained on the measurements prior to the registry start.
Additionally, all investigators are trained and certified in the EXOPULSE method, and the generic stimulation settings are selected according to a standardized matrix based on the subjects' age and level of impairment.
Re-assessments during scheduled visits are part of normal routine and use. The decision whether the subjects will be enrolled in the registry is separated from the subject's decision to use the device.
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
Study design
Enrollment target: 200 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2026-02-18
Estimated completion: 2027-12-31
Last updated: 2026-02-27
Interventions
Device: EXOPULSE Mollii Suit and EXOPULSE Suit
Primary outcomes
- • Berg's Balance Scale (To be assessed at baseline, after 60 minutes stimulation (T1), and after 2 weeks of home use (T2).)
Sponsor
Exoneural Network AB · industry
Contacts & investigators
ContactMilana Mileusnic, PhD · contact · milana.mileusnic@ottobock.com · +43 6648415079
ContactSanna Dünesius, MSc · contact · sanna.dunesius@ottobock.com · +46 706243064
InvestigatorMilana Mileusnic, PhD · principal_investigator, Otto Bock Healthcare Products GmbH
All locations (1)
Ottobock Care SverigeRecruiting
Bergshamra, Stockholm County, Sweden