Effectiveness of the EXOPULSE Mollii Ⓡ Suit in Patients With Multiple Sclerosis - Trial NCT06384729

Timeline & Enrollment

Primary Outcome

referred pain,Balance,gait speed and distance

Summary

Abstract:
 
 Background:
 
 Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central
 nervous system with unknown etiology, causing a variety of symptoms including impaired
 balance, coordination, and walking difficulties. The Exopulse Mollii Ⓡ suit is an innovative
 approach for non-invasive, self-administered electrical stimulation designed to alleviate
 spasticity and improve motor function in various neurological conditions.
 
 Objective:
 
 To determine the effectiveness of the Exopulse Mollii Ⓡ suit in improving motor control in
 patients with MS.
 
 Methods:
 
 A randomized, double-blind clinical trial will be conducted, recruiting patients diagnosed
 with MS , aged 18 or above, with a Functional Ambulation Category (FAC) score between 2 and
 4. Patients will be randomly assigned to two groups receiving either inactive or active
 Exopulse Mollii Ⓡ treatment for 60 minutes, three times a week, for three weeks. Outcome
 measures include pain, balance, gait speed, risk of falls, perception of walking
 difficulties, and quality of life assessed using validated scales. Statistical analysis will
 be performed using SPSS v.29.0.0.0.
 
 Results:
 
 Data on age, sex, weight, and MS-related factors will be collected at baseline. Primary
 outcomes include changes in pain, balance, and gait speed, while secondary outcomes encompass
 risk of falls, perception of walking difficulties, and quality of life. Analysis will compare
 mean differences between groups using appropriate statistical tests.
 
 Conclusion:
 
 This study aims to evaluate the efficacy of the Exopulse Mollii Ⓡ suit in enhancing motor
 function in MS patients. Findings may contribute to the development of novel therapeutic
 strategies for managing MS-related symptoms and improving patients' quality of life.

ICD-10 Classifications