The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EXOPULSE Mollii Suit and EXOPULSE Suit.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy, Multiple Sclerosis, Stroke, Neurologic Disorder. Basic parameters: from 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Interventions
- Device EXOPULSE 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
Primary outcome measures
- Berg's Balance Scale [Time frame: To be assessed at baseline, after 60 minutes stimulation (T1), and after 2 weeks of home use (T2).]
Secondary outcome measures (9)
- Timed Up and Go (TUG), if applicable for the patient [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: To be assessed at baseline, after two weeks of home use (T2) and during the two additional phone calls (T1,5 and T3 respectively).]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Sweden · 1 center
- Ottobock Care Sverige — Bergshamra
Identifiers
NCT: NCT05901259 · CIV-22-08-040366