Cerebral PalsyEXOREGNCT05901259
The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes
An observational study of Cerebral Palsy and Multiple Sclerosis, run by Otto Bock Healthcare Products GmbH at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Cerebral Palsy, Multiple Sclerosis, Stroke
- What is being tested?
- EXOPULSE Mollii Suit and EXOPULSE Suit
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 18 Feb 2026to 31 Dec 2027
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects over 2 years of age diagnosed with CP, MS, stroke, fibromyalgia or other neurologic disorder that may cause such type of symptoms.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Ottobock Care Sverige
Bergshamra, Stockholm County, 170 73
Ines Cunha, ines.cunha@ottobockcare.se
About this study
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.
Read the 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.
- Conditions
- Cerebral Palsy, Multiple Sclerosis, Stroke, Neurologic Disorder, Fibromyalgia
- Being tested
- EXOPULSE Mollii Suit and EXOPULSE Suit
- Keywords
- EXOREG
- Medical subject headings
- Cerebral Palsy, Multiple Sclerosis, Stroke, Nervous System Diseases, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXOPULSE Mollii Suit and EXOPULSE SuitDevice
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: To be assessed at baseline, after 60 minutes stimulation (T1), and after 2 weeks of home use (T2).
Secondary outcomes (9)
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.
Measured: 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
The 10mWT is used to assess the change in walking speed in meters/second (m/s) over a short distance.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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
Measured: 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
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.
Measured: 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
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.
Measured: 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
SSS calculates severity scores of a number of Fibromyalgia-related symptoms. Together, the WPI and SSS can be used as diagnostic criteria for Fibromyalgia.
Measured: To be assessed at baseline, after two weeks of home use (T2) and during the two additional phone calls (T1,5 and T3 respectively).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start18 Feb 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Otto Bock Healthcare Products GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Milana Mileusnic, PhD, Principal investigator, Otto Bock Healthcare Products GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901259
- Sponsor's protocol ID
- CIV-22-08-040366
- Acronym
- EXOREG
- Status last verified
- Sep 2026
- First submitted
- 29 May 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes
- ClinicalTrials.gov ID
- NCT05901259
- Acronym / sponsor ID
- EXOREG / CIV-22-08-040366
- Conditions
- Cerebral Palsy, Multiple Sclerosis, Stroke, Neurologic Disorder, Fibromyalgia
- Keywords
- EXOREG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Otto Bock Healthcare Products GmbHIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Weeks
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects over 2 years of age diagnosed with CP, MS, stroke, fibromyalgia or other neurologic disorder that may cause such type of symptoms.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXOPULSE Mollii Suit and EXOPULSE SuitThe 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). | Device | – |
Primary outcome
Berg's Balance Scale
Time frame: 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.
9 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Milana Mileusnic, PhD principal investigator
Otto Bock Healthcare Products GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Multiple Sclerosis, run by Otto Bock Healthcare Products GmbH at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Milana Mileusnic, PhD (+43 6648415079, milana.mileusnic@ottobock.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg's Balance Scale (time frame: To be assessed at baseline, after 60 minutes stimulation (T1), and after 2 weeks of home use (T2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.