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

CompletedNA

Sponsor: Universidad Europea de Madrid

Conditions: Multiple Sclerosis

Interventions: EXOPULSE Mollii Ⓡ

Countries: Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* • Diagnosis of Multiple Sclerosis as confirmed by a physician using McDonald's criteria.

  * Age over 18 years.
  * Ability to comprehend verbal commands.
  * Scoring between 2 and 4 on the Functional Ambulation Category (FAC).

Exclusion Criteria:

* Pregnancy.

  * Having an intrathecal baclofen pump.
  * Having received botulinum toxin injections in the last 3 months.
  * Wearing electronic or magnetic medical devices (pacemakers, shunts, etc.) that may be affected by magnets.
  * BMI \> 35.

Locations (1)

Villaviciosa de Odón, Madrid, Spain