The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorOtto Bock Healthcare Products GmbH
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Subjects over 2 years of age diagnosed with CP, MS, stroke, fibromyalgia or other neurologic disorder that may cause such type of symptoms.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
EXOPULSE Mollii Suit and EXOPULSE Suit
DeviceThe 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).
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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), and after 2 weeks of home use (T2).Secondary outcomes
1
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.
Time frame
To be assessed at baseline, immediately after 60 minutes stimulation (T1), and after two weeks of home use (T2).2
10 m Walk Test, if applicable for the patient
The 10mWT is used to assess the change in walking speed in meters/second (m/s) over a short distance.
Time frame
To be assessed at baseline, immediately after 60 minutes stimulation (T1), and after two weeks of home use (T2).3
Numeric Rating Scale (NRS), if applicable for the patient
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.
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).4
EQ-5D-5L, if applicable for the patient
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.
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).Sponsors and contacts
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Source ClinicalTrials.gov