The Exopulse Mollii Suit Study - a Database for Routine Follow-up of Clinical Outcomes

N/ANot Yet RecruitingNCT05901259

Exoneural Network AB200 enrolled

Overview

The objective is to explore the potential short and long-term impact of the Exopulse Mollii Suit on subjects with CP, MS, stroke, SCI or other neurological 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 improvement on the Berg/Pediatric Balance Scale (BBS) as a measurement of balance and risk of falls.

The registry is designed to demonstrate the impact of Exopulse Mollii Suit on improvement and 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 cannot 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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Cerebral Palsy Multiple Sclerosis Stroke

Interventions

Exopulse Mollii SuitDEVICE

The registry is designed to demonstrate the impact of Exopulse Mollii Suit on improvement of 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 12 consecutive weeks. Qualitative and quantitative measures will be collected at baseline (T0), after 60 minutes stimulation (T1), after 4 weeks (T4) and at the end of the 12-week intervention period (T12).

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with CP, MS, stroke, spinal cord injury or other neurologic disorder that may cause such type of symptoms. * Diagnosed \>6 months prior to inclusion in case of MS, stroke, or SCI * 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 * 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

Outcomes

Primary Outcomes

Berg's Balance Scale

Change in balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in Patients with Multiple Sclerosis (concurrent validity, interrater reliability). The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with risk of fall across the literature.

Time frame: To be assessed at baseline, after 60 minutes stimulation (T1), after 4 weeks (T4) and at the end of the 12-week intervention period (T12).

Secondary Outcomes

Timed Up and Go (TUG), if applicable for the patient

Change in walking velocity will be assessed with TUG. Patients have to stand up from a chair when they hear the verbal instruction "go", walk a distance of 3 meters, turn around, walk back to the chair and sit down. Timing starts with the verbal instruction "go' and stops when the patients return to the seated position. The score consists of the time taken to complete the test activity, measured in seconds.