Cerebral Palsy, Fibromyalgia, Multiple Sclerosis, Neurologic Disorder, Stroke
Conditions
Keywords
EXOREG
Brief summary
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
DEVICEEXOPULSE 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 use (T2) and during two additional phone calls 1-3 days after the first stimulation session (T1,5) as well as 4 weeks after the first stimulation session (T3).
Sponsors
Otto Bock Healthcare Products GmbH
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Berg's Balance Scale | To be assessed at baseline, after 60 minutes stimulation (T1), and after 2 weeks of home use (T2). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go (TUG), if applicable for the patient | To be assessed at baseline, immediately after 60 minutes stimulation (T1), and after two weeks of home use (T2). | 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. |
| 10 m Walk Test, if applicable for the patient | To be assessed at baseline, immediately after 60 minutes stimulation (T1), and after two weeks of home use (T2). | The 10mWT is used to assess the change in walking speed in meters/second (m/s) over a short distance. |
| Numeric Rating Scale (NRS), if applicable for the patient | 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). | The change in pain will be assess with NRS. NRS measures the subjective intensity of pain, where 0=no pain and 10=worst pain imaginable. |
| EQ-5D-5L, if applicable for the patient | To be assessed at baseline, after two weeks of home use (T2) and during the two additional phone calls (T1,5 and T3 respectively). | The change in quality of life will be assessed with EQ-5D, which is an instrument that evaluates the generic quality of life. Designed as a self-completion questionnaire, it embodies two components, a health state description followed by an evaluation.The respondent classifies his or her prevailing state of health by selecting one of three different levels of problem severity within each of five health domains. |
| Revised Fibromyalgia Impact Questionnaire (FIQR), if applicable for the patient | To be assessed at baseline, after 2 weeks of home use and during the two additional phone calls (T1,5 and T3 respectively). | The FIQR evaluates the function, overall impact and symptoms of fibromyalgia over the last 7 days. The Fibromyalgia Impact Questionnaire (FIQ) is a well-established and commonly used instrument to evaluate Fibromyalgia patients. The FIQR is a revised version of the FIQ, that has the same 3 domains, i.e. function, overall impact and symptoms. The FIQR also consists of modified function questions as well as questions on memory, tenderness, balance and environmental sensitivity. All questions are graded on a 0-10 numeric scale. |
| Box and Block Test (BBT), if applicable to the patient | To be assessed at baseline, immediately after 60 minutes stimulation (T1) and after two weeks of home use (T2) | The Box and Block Test (BBT) measures unilateral gross manual dexterity in patients with neurological diagnoses. Patients are scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds |
| 12-item Multiple Sclerosis Walking Scale (MSWS-12) , if applicable for the patient | To be assessed at baseline, after two weeks of home use (T2) and during the two additional phone calls (T1,5 and T3 respectively). | The MSWS-12 is a self-report measure of the impact of MS on the individual's walking ability. It contains 12 questions with Likert-type responses and has a recall period of 2 weeks. The psychometric properties of the MSWS-12 have been extensively evaluated in diverse MS populations in both community and hospital settings, with demonstration of internal consistency, high reliability and validity, and good generalizability. The MSWS-12 is less prone to floor and ceiling effects than are other tools, suggesting adequate assessment of the impact of walking impairment across the range of disability. |
| Widespread Pain Index (WPI) , if applicable for the patient | 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). | The WPI is based on a standardized questionnaire. Patients are asked in which regions of the body they have experienced pain in the past seven days. In total, the WPI measures pain in 19 defined body regions or pain zones. It is supposed to be used in combination with the Symptom Severity Scale. |
| Symptom Severity Scale (SSS) , if applicable for the patient | To be assessed at baseline, after two weeks of home use (T2) and during the two additional phone calls (T1,5 and T3 respectively). | SSS calculates severity scores of a number of Fibromyalgia-related symptoms. Together, the WPI and SSS can be used as diagnostic criteria for Fibromyalgia. |
Countries
Sweden
Contacts
CONTACTMilana Mileusnic, PhD
PRINCIPAL_INVESTIGATORMilana Mileusnic, PhD
Otto Bock Healthcare Products GmbH
Outcome results
None listed