Effectiveness of the EXOPULSE Mollii Ⓡ Suit in Patients With Multiple
Effectiveness of the EXOPULSE Mollii Ⓡ Suit in Patients With Multiple Sclerosis: Randomized Clinical Trial
We could not find results for this trial
What it found
We found no results in the registry or in papers.
This trial finished 2 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- EXOPULSE Mollii Ⓡ
What it measured
Main measures
referred pain
3 weeks
PainBalance
3 weeks
Walking and mobilitygait speed and distance
3 weeks
Walking and mobility
Other measures (3)
fall risk
3 weeks
Walking and mobilityperception of walking difficulties
3 weeks
Walking and mobilityperceived quality of life
3 weeks
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 18 and over
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Apr 2024
Main results due
May 2024
Finished
Sept 2024