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

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.

• Timed Up and Go (TUG), if applicable for the patient [Срок оценки: To be assessed at baseline, immediately after 60 minutes stimulation (T1), and after two weeks of home use (T2).]
• 10 m Walk Test, if applicable for the patient [Срок оценки: To be assessed at baseline, immediately after 60 minutes stimulation (T1), and after two weeks of home use (T2).]
• Numeric Rating Scale (NRS), if applicable for the patient [Срок оценки: To be assessed at baseline, immediately after 60 minutes stimulation (T1), after two weeks of home use (T2) and during the two additional phone calls (T1,5 and T3 respectively).]
• EQ-5D-5L, if applicable for the patient [Срок оценки: To be assessed at baseline, after two weeks of home use (T2) and during the two additional phone calls (T1,5 and T3 respectively).]
• Revised Fibromyalgia Impact Questionnaire (FIQR), if applicable for the patient [Срок оценки: To be assessed at baseline, after 2 weeks of home use and during the two additional phone calls (T1,5 and T3 respectively).]
• Box and Block Test (BBT), if applicable to the patient [Срок оценки: To be assessed at baseline, immediately after 60 minutes stimulation (T1) and after two weeks of home use (T2)]
• 12-item Multiple Sclerosis Walking Scale (MSWS-12) , if applicable for the patient [Срок оценки: To be assessed at baseline, after two weeks of home use (T2) and during the two additional phone calls (T1,5 and T3 respectively).]
• Widespread Pain Index (WPI) , if applicable for the patient [Срок оценки: To be assessed at baseline, immediately after 60 minutes stimulation (T1), after two weeks of home use (T2) and and during the two additional phone calls (T1,5 and T3 respectively).]
• Symptom Severity Scale (SSS) , if applicable for the patient [Срок оценки: To be assessed at baseline, after two weeks of home use (T2) and during the two additional phone calls (T1,5 and T3 respectively).]