EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE 2) — EXOSTROKE2  

Stroke Clinical Trial

Official title: The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Stroke (EXOSTROKE 2)"

Status Recruiting

Clinical Trial 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 it aims to answer are:

to evaluate the short-term impact of EXOPULSE Mollii suit on balance in adult patients with stroke and suffering from spasticity.

to assess the effects of Exopulse Mollii suit on spasticity, mobility, pain, fatigue and QoL.

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Participants will participate in:

One baseline visit for inclusion during which the patient will undergo the first session (active or sham) along with evaluations (before and after the session) One visit after two weeks during which the patient will undergo the second session (active or sham) along with evaluations (before and after the session) One visit after two weeks of the second stimulation condition; the patients will undergo a third evaluation and receive the EXOPULSE Mollii Suit for the four-week open label phase and will use the suit at home for an active stimulation session every other day for four weeks.

One visit at the end of the open label phase to perform the fourth and last evaluation and return the EXOPULSE Mollii suit.

Researchers will compare both Active and Sham groups to demonstrate the improvement of motor functions related symptoms in patients with stroke and spasticity using Exopulse Mollii suit.

Clinical Trial 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 "sham" EXOPULSE Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. Two weeks after the end of this phase (phase 1), a second phase of this trial, an open label phase, will be proposed for all patients to understand the effects of EXOPULSE Mollii suit employed over 4 weeks (a session every other day for a total of 14 sessions) on stroke related symptoms. ;

Related Conditions & MeSH terms

• Muscle Spasticity
• Spastic
• Spasticity, Muscle
• Stroke

• NCT number: NCT06214975
• Study type: Interventional
• Source: Sheikh Shakhbout Medical City
• Contact: Naji J Riachi, MD
• Phone: +97123144444
• Email: nriachi@ssmc.ae
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2023
• Completion date: December 2, 2024