Improving motor functions in stroke patients using the Exopulse Mollii suit
The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Stroke (EXOSTROKE 2)"
This study is testing if wearing the Exopulse Mollii suit can help improve movement and reduce symptoms for people who have had a stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sheikh Shakhbout Medical City Academic / other |
| Locations | 1 site (Abu Dhabi) |
| Trial ID | NCT06214975 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the Exopulse Mollii suit in enhancing motor functions and alleviating symptoms related to stroke and spasticity. Participants will undergo a randomized crossover design, receiving either active or sham stimulation, followed by a four-week open-label phase where they will use the suit regularly. The study will assess various outcomes, including balance, mobility, pain, fatigue, and quality of life. Evaluations will occur at baseline, after two weeks, and after the open-label phase to measure the impact of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 who have experienced a stroke at least three months prior and exhibit spasticity.
Not a fit: Patients with contraindications to using the Exopulse Mollii suit or those with other serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve motor function and quality of life for stroke patients suffering from spasticity.
How similar studies have performed: While the specific use of the Exopulse Mollii suit is novel, similar approaches using electrical stimulation for motor function improvement in stroke patients have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 75 years. * Having a clinical diagnosis of stroke since at least three months. * Being able to walk freely or with the need of support (modified Rankin score ≤ 4). * Able to understand verbal instructions. * Having spasticity with a score of at least 1+ on the MAS. * Having a BBS score ≤46 associated in the literature with a risk of fall. Exclusion Criteria: * Being included in another research protocol during the study period. * Inability to undergo medical monitor for the study purposes due to geographical or social reasons. * Having a cardiac stimulator, a ventriculoperitoneal shunt, an intrathecal baclofen pump or other contraindications to using EXOPULSE Mollii suit. * Being pregnant. * Having a change in their stroke pharmacological therapy in the last three months. * Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain). * Having a body mass index above 35 Kg/m2. * In case of the introduction of a medical device other than EXOPULSE Mollii suit during the study period. * Patients under juridical protection. * Prisoners.
Where this trial is running
Abu Dhabi
- Ssmc — Abu Dhabi, United Arab Emirates (Recruiting)
Study contacts
- Principal investigator: Naji J Riachi, MD — Ssmc
- Study coordinator: Naji J Riachi, MD
- Email: nriachi@ssmc.ae
- Phone: +97123144444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.