Clinical trial NCT06214975: EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE 2)
Official title: The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Stroke (EXOSTROKE 2)"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Spasticity, Muscle
Spastic
Lead sponsor: Sheikh Shakhbout Medical City
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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 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.

.

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.

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 "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.

Eligibility 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.

Primary outcomes:
measure: Balance using Berg Balance Scale (BBS)
timeFrame: To be assessed at baseline.
measure: Balance using Berg Balance Scale (BBS)
timeFrame: To be assessed at week 2.
measure: Balance using Berg Balance Scale (BBS)
timeFrame: To be assessed at week 4.
measure: Balance using Berg Balance Scale (BBS)
timeFrame: To be assessed at week 8.
Secondary outcomes:
measure: Visual Analog Score for spasticity.
timeFrame: This to be assessed at baseline, then at week 2, week 4 and week 8.
measure: Visual Analog Score for pain.
timeFrame: This to be assessed at baseline, then at week 2, week 4 and week 8.
measure: EQ-5D-5L: EuroQol 5 Dimensions 5 Levels Quality of Life Questionnaire
timeFrame: Two weeks after the second stimulation and 4 weeks later at the end of phase 2.
measure: Overall Clinical improvement
timeFrame: This to be assessed at baseline, then at week 2, and week 8.
measure: Blinding Questionnaire
timeFrame: This to be assessed at baseline, then at week 2.
measure: Visual Analog Score for fatigue
timeFrame: This to be assessed at baseline, then at week 2, week 4 and week 8.
measure: Muscle tone.
timeFrame: This to be assessed at baseline, then at week 2, week 4 and week 8.
measure: Fall Risk
timeFrame: Two weeks after the second stimulation and 4 weeks later at the end of phase 2.
measure: Weight
timeFrame: Baseline.
measure: Height
timeFrame: Baseline
measure: Time Up and Go (TUG)
timeFrame: This to be assessed at baseline, then at week 2, week 4 and week 8.
measure: Body Mass Index (BMI)
timeFrame: Baseline
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: SSMC
Study officials:
affiliation: SSMC
name: Naji J Riachi, MD
role: PRINCIPAL_INVESTIGATOR
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