Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384729
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-08
Brief Title:
Effectiveness of the EXOPULSE Mollii Suit in Patients With Multiple Sclerosis
Sponsor:
Universidad Europea de Madrid
Organization:
Universidad Europea de Madrid
Study Overview
Official Title:
Effectiveness of the EXOPULSE Mollii Suit in Patients With Multiple Sclerosis Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 v29000
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
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 v29000
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
Detailed Description:
Introduction
Multiple sclerosis MS is a chronic inflammatory demyelinating disease of the central nervous system with unknown etiology Common symptoms include fatigue visual disturbances balance and coordination problems sensory disturbances spasticity cognitive and emotional disorders speech impairments bladder and bowel issues and sexual dysfunction MS affects approximately 22 million people worldwide Gait abnormalities are a distinctive feature of MS and a significant cause of disability and reduced health-related quality of life Individuals with MS typically exhibit slower walking speeds lower cadence and increased variability between strides attributed to demyelination resulting in reduced conductivity in the somatosensory nervous system decreased muscle strength vestibular dysfunction and severe fatigue
The EXOPULSE Mollii method is an innovative approach to non-invasive self-administered electrical stimulation using multiple electrodes incorporated into a full-body suit Comprising comfortable breathable and washable synthetic material the Mollii suit primarily aims to alleviate disabling spasticity and enhance motor function The method operates on the concept of reciprocal inhibition induced by stimulating the antagonist of a spastic muscle at low frequencies and intensities thus considered to reduce spasticity Moreover the EXOPULSE Mollii suit has demonstrated benefits in children with cerebral palsy spasticity and chronic stroke patients Therefore this study aims to evaluate the effects of a 60-minute session with the EXOPULSE Mollii suit on patients with multiple sclerosis
Methodology
A randomized double-blind clinical trial will be conducted with two investigators performing the intervention and a third responsible for programming the suits and attaching the belt Patients will be recruited from the Fivan Foundation where the intervention will take place Recruitment and patient selection will be conducted through therapists at the center informed in advance about the projects content The suits provided by the Fivan Foundation and Ottobock consist of comfortable breathable and washable synthetic pants and jackets Patients meeting the following inclusion criteria will be selected
Diagnosed with multiple sclerosis by their physician
Aged 18 or above
Able to understand verbal commands
Having a Functional Ambulation Category FAC score between 2 and 4
Exclusion criteria include
Pregnancy
Having an intrathecal baclofen pump
Having received botulinum toxin infiltration in the last 3 months
Wearing electronic or magnetic medical devices pacemakers shunts etc that may be affected by magnets
BMI 35
Patients will be randomly divided into two groups using a coin toss method An initial individual assessment session will be conducted including randomization providing each patient with an assessment sheet and obtaining informed consent The control group will wear the Exopulse Mollii suit with parameters set to 0 while the second group will wear the same suit with parameters adjusted to each individual assessment Both groups will undergo 60-minute sessions three times a week for three weeks to assess potential beneficial effects of this device for MS patients At three weeks a crossover will occur with the group initially having parameters set to 0 now receiving treatment for another 3 weeks while the other group will have the treatment discontinued to assess maintenance of effects Initial 3-week and 6-week assessments will be conducted for both groups using previously validated scales detailed in the following section This intervention will be added to the patients usual treatment without interfering with it Sample size was determined using the GRANMO program with 11 subjects per group considering an alpha risk of 005 a beta risk below 02 in a bilateral contrast and an estimation based on a common standard deviation of 489 taking into account a 5 follow-up loss rate
Multiple sclerosis MS is a chronic inflammatory demyelinating disease of the central nervous system with unknown etiology Common symptoms include fatigue visual disturbances balance and coordination problems sensory disturbances spasticity cognitive and emotional disorders speech impairments bladder and bowel issues and sexual dysfunction MS affects approximately 22 million people worldwide Gait abnormalities are a distinctive feature of MS and a significant cause of disability and reduced health-related quality of life Individuals with MS typically exhibit slower walking speeds lower cadence and increased variability between strides attributed to demyelination resulting in reduced conductivity in the somatosensory nervous system decreased muscle strength vestibular dysfunction and severe fatigue
The EXOPULSE Mollii method is an innovative approach to non-invasive self-administered electrical stimulation using multiple electrodes incorporated into a full-body suit Comprising comfortable breathable and washable synthetic material the Mollii suit primarily aims to alleviate disabling spasticity and enhance motor function The method operates on the concept of reciprocal inhibition induced by stimulating the antagonist of a spastic muscle at low frequencies and intensities thus considered to reduce spasticity Moreover the EXOPULSE Mollii suit has demonstrated benefits in children with cerebral palsy spasticity and chronic stroke patients Therefore this study aims to evaluate the effects of a 60-minute session with the EXOPULSE Mollii suit on patients with multiple sclerosis
Methodology
A randomized double-blind clinical trial will be conducted with two investigators performing the intervention and a third responsible for programming the suits and attaching the belt Patients will be recruited from the Fivan Foundation where the intervention will take place Recruitment and patient selection will be conducted through therapists at the center informed in advance about the projects content The suits provided by the Fivan Foundation and Ottobock consist of comfortable breathable and washable synthetic pants and jackets Patients meeting the following inclusion criteria will be selected
Diagnosed with multiple sclerosis by their physician
Aged 18 or above
Able to understand verbal commands
Having a Functional Ambulation Category FAC score between 2 and 4
Exclusion criteria include
Pregnancy
Having an intrathecal baclofen pump
Having received botulinum toxin infiltration in the last 3 months
Wearing electronic or magnetic medical devices pacemakers shunts etc that may be affected by magnets
BMI 35
Patients will be randomly divided into two groups using a coin toss method An initial individual assessment session will be conducted including randomization providing each patient with an assessment sheet and obtaining informed consent The control group will wear the Exopulse Mollii suit with parameters set to 0 while the second group will wear the same suit with parameters adjusted to each individual assessment Both groups will undergo 60-minute sessions three times a week for three weeks to assess potential beneficial effects of this device for MS patients At three weeks a crossover will occur with the group initially having parameters set to 0 now receiving treatment for another 3 weeks while the other group will have the treatment discontinued to assess maintenance of effects Initial 3-week and 6-week assessments will be conducted for both groups using previously validated scales detailed in the following section This intervention will be added to the patients usual treatment without interfering with it Sample size was determined using the GRANMO program with 11 subjects per group considering an alpha risk of 005 a beta risk below 02 in a bilateral contrast and an estimation based on a common standard deviation of 489 taking into account a 5 follow-up loss rate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None