About this trial
This study is being carried out at Multiple Sclerosis (MS) centers to evaluate whether a full-body stimulation suit at home can help people with Multiple Sclerosis (pwMS) reduce symptoms like spasticity (muscle stiffness) and ataxia (poor coordination), and improve daily functioning.
Can pwMS who experience spasticity or ataxia benefit from using a stimulation suit for 6 weeks?
Researchers will compare two groups: an intervention group (who will use the suit) and a control group (who will not use the suit).
Participants in the intervention group will:
* Wear the suit for 6 weeks in total every day or every other day (1 week during their MS center admission and 5 weeks at home). * Receive their usual care in addition to wearing the suit. * Undergo clinical tests at the MS center after 1 week and 6 weeks of stimulation.
Participants in the control group will:
* Receive their usual care. * Undergo clincial tests at the same time points as the other group.
Eligibility criteria
Qualifiers
Eligible participants must have ataxia or spasticity alongside impairments in upper or lower extremity physical function. MAS score ≥ 1 will be used as an inclusion criterion to determine the presence of spasticity. SARA score ≥ 4 will be used as an inclusion criterion to determine the presence of ataxia. Note: one of the two criteria (MAS score or SARA score) must be fulfilled for a pwMS to be eligible.
The patient must have the cognitive abilities to understand instructions and to be able to complete the questionnaires adequately
Diagnosis of multiple sclerosis.
Disqualifiers
Implanted devices (like pacemaker, Baclofen pump, neurostimulator, defibrillator, shunts, ECG equipment, electronic life support, high frequency operation equipment )
Change in disease modifying treatment within the last 3 months
Use of Botuline Toxine A within the last 3months
Recent relapse within the last 3 months
Trial design
Treatments tested in this trial
- electro-stimulation suit
- Usual Care
Treatment groups
Sponsors and collaborators
Daphne Kos
Lead sponsor
Universitair Ziekenhuis Brussel
Sponsor institution
Danish MS Hospitals, Haslev and Ry
Collaborator
Universitair Ziekenhuis Brussel
Collaborator
National MS Center Melsbroek
Collaborator