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

NCT05901259 | Recruiting

• 1 other identifier: CIV-22-08-040366
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Multiple Sclerosis; Stroke; Neurologic Disorder; Fibromyalgia

Keywords

EXOREG

Outcome Measures

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.

  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

  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

  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

  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

  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

  To be assessed at baseline, after 2 weeks of home use and during the two additional phone calls (T1,5 and T3 respectively).

Interventions

EXOPULSE Mollii Suit and EXOPULSE Suit DEVICE

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).

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Diagnosed with CP, MS, stroke, fibromyalgia or other neurologic disorder that may cause such type of symptoms.
• Give written informed consent
• Cognitively able to understand and follow verbal and/or written instructions
• A minimum age of 2 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Exoneural Network AB: lead

Study Sites (1)

Ottobock Care Sverige

Bergshamra, Stockholm County, 170 73, Sweden

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Multiple Sclerosis; Stroke; Nervous System Diseases; Fibromyalgia

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases

Study Officials

• Milana Mileusnic, PhD

  Otto Bock Healthcare Products GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Milana Mileusnic, PhD

CONTACT

+43 6648415079; milana.mileusnic@ottobock.com

Sanna Dünesius, MSc

CONTACT

+46 706243064; sanna.dunesius@ottobock.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 4 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 13, 2023
• Study Start: February 18, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

SE (1)