Status:
RECRUITING
EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE 2)
Lead Sponsor:
Sheikh Shakhbout Medical City
Conditions:
Stroke
Spasticity, Muscle
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to demonstrate the improvement of motor functions related symptoms in patients with stroke and spasticity using Exopulse Mollii suit stimulation. The main questions...
Detailed Description
The study is a randomized crossover, sham-controlled, double-blind trial to demonstrate the improvement of motor functions and stroke related symptoms following a single session of "active" versus "sh...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 2 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06214975
Start Date
October 24 2023
End Date
December 2 2024
Last Update
January 22 2024
Active Locations (1)
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1
SSMC
Abu Dhabi, United Arab Emirates