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

NCT06214975 | Unknown

• 1 other identifier: EXOSTROKE2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Spasticity, Muscle; Spastic

Outcome Measures

Primary Outcomes (4)

• Balance using Berg Balance Scale (BBS)

  Balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in patients with stroke (concurrent validity, interrater reliability). The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with risk of fall across the literature.

  To be assessed at baseline.

• Balance using Berg Balance Scale (BBS)

  Balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in patients with stroke (concurrent validity, interrater reliability). The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with risk of fall across the literature.

  To be assessed at week 2.

• Balance using Berg Balance Scale (BBS)

  Balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in patients with stroke (concurrent validity, interrater reliability). The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with risk of fall across the literature.

  To be assessed at week 4.

• Balance using Berg Balance Scale (BBS)

  Balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in patients with stroke (concurrent validity, interrater reliability). The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with risk of fall across the literature.

  To be assessed at week 8.

Secondary Outcomes (12)

• Visual Analog Score for spasticity.

  This to be assessed at baseline, then at week 2, week 4 and week 8.

• Visual Analog Score for pain.

  This to be assessed at baseline, then at week 2, week 4 and week 8.

• EQ-5D-5L: EuroQol 5 Dimensions 5 Levels Quality of Life Questionnaire

  Two weeks after the second stimulation and 4 weeks later at the end of phase 2.

• Overall Clinical improvement

  This to be assessed at baseline, then at week 2, and week 8.

• Blinding Questionnaire

  This to be assessed at baseline, then at week 2.

Study Arms (2)

EXOPULSE Mollii Suit Stimulation Active

ACTIVE COMPARATOR

This will be the EXOPULSE Mollii Suit Active Stimulation. Stimulation will go on for 60 minutes while control unit is on for 60 minutes

Device: EXOPULSE Mollii Suit Stimulation

EXOPULSE Mollii Suit Stimulation Sham

SHAM COMPARATOR

This will be the EXOPULSE Mollii Suit Sham Stimulation. Stimulation will go on for 1 minute then it turns off while the control unit will remain on for total of 60 minutes.

Device: EXOPULSE Mollii Suit Stimulation

Interventions

EXOPULSE Mollii Suit Stimulation DEVICE

We designed 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 stimulation. in phase 1, the patient will receive two stimulations separated by a two-week washout period. The patients will be randomized to receive either active/sham or sham/active and both patients and investigators will be blinded to the order in which the stimulation will be given. A 2-week washout period should be enough to prevent a potential carry over effect. Two weeks after the end of phase 1, a second open label phase (phase 2) of this trial will be proposed to all patients where they will receive active stimulation every other day at home over four weeks (for a total of 14 sessions). This will help understand the long term effects of EXOPULSE Mollii suit stimulation on stroke related symptoms.

EXOPULSE Mollii Suit Stimulation Active; EXOPULSE Mollii Suit Stimulation Sham

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheikh Shakhbout Medical City: lead

Study Sites (1)

SSMC

Abu Dhabi, United Arab Emirates

RECRUITING

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MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Naji J Riachi, MD

  SSMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naji J Riachi, MD

CONTACT

+97123144444; nriachi@ssmc.ae

Hasan M Jaber, Bsc

CONTACT

+97123144444; hasjaber@ssmc.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: January 22, 2024
• Study Start: October 24, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 2, 2024
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)