Clinical trial NCT05901259: The Exopulse Mollii Suit Study - a Database for Routine Follow-up of Clinical Outcomes
Official title: The Exopulse Mollii Suit Study - a Database for Routine Follow-up of Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cerebral Palsy
Multiple Sclerosis
Stroke
Spinal Cord Injuries
Neurologic Disorder
Lead sponsor: Exoneural Network AB
Sponsor class: INDUSTRY
First posted: 2023-06-13
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects over 2 years of age diagnosed with CP, MS, stroke, spinal cord injury or other neurologic disorder that may cause such type of symptoms.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Berg's Balance Scale
timeFrame: 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:
measure: Timed Up and Go (TUG), if applicable for the patient
timeFrame: To be assessed at baseline, immediately after 60 minutes stimulation (T1), 4 weeks after first visit (T4) and at the end of the 12-week intervention period (T12).
measure: 10 m Walk Test, if applicable for the patient
timeFrame: To be assessed at baseline, immediately after 60 minutes stimulation (T1), 4 weeks after first visit (T4) and at the end of the 12-week intervention period (T12).
measure: Wolf Motor Function Test, if applicable for the patient
timeFrame: To be assessed at baseline, immediately after 60 minutes stimulation (T1), 4 weeks after first visit (T4) and at the end of the 12-week intervention period (T12).
measure: Numeric Rating Scale (NRS), if applicable for the patient
timeFrame: To be assessed at baseline, immediately after 60 minutes stimulation (T1), 4 weeks after first visit (T4) and at the end of the 12-week intervention period (T12).
measure: EQ-5D-5L, if applicable for the patient
timeFrame: To be assessed at baseline, immediately after 60 minutes stimulation (T1), 4 weeks after first visit (T4) and at the end of the 12-week intervention period (T12).
measure: Fibromyalgia Impact Questionnaire (FIQ), if applicable for the patient
timeFrame: To be assessed at baseline, immediately after 60 minutes stimulation (T1), 4 weeks after first visit (T4) and at the end of the 12-week intervention period (T12).
measure: Quebec Back Pain Disability Scale, if applicable for the patient
timeFrame: To be assessed at baseline, immediately after 60 minutes stimulation (T1), 4 weeks after first visit (T4) and at the end of the 12-week intervention period (T12).
measure: Near Infrared Spectroscopy (NIRS), if applicable for the patient
timeFrame: To be assessed at baseline, immediately after 60 minutes stimulation (T1), 4 weeks after first visit (T4) and at the end of the 12-week intervention period (T12).
Other outcomes:
Locations:
city: Bergshamra
country: Sweden
facility: Exoneural Network Ab
state: Stockholm
Study officials:
affiliation: Exoneural Network AB
name: Mimi Westerlund, Phd
role: PRINCIPAL_INVESTIGATOR
References: