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

January 17, 2024 updated by: Naji Joseph Riachi, Sheikh Shakhbout Medical City

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Naji J Riachi, MD
  • Phone Number: 2979 +97123144444
  • Email: nriachi@ssmc.ae

Study Contact Backup

  • Name: Hasan M Jaber, Bsc
  • Phone Number: 3869 +97123144444
  • Email: hasjaber@ssmc.ae

Study Locations

  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Recruiting
        • SSMC
        • Contact:
          • Naji J Riachi, MD
          • Phone Number: 2979 +971 2 314 4444
          • Email: nriachi@ssmc.ae
        • Contact:
        • Principal Investigator:
          • Naji J Riachi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: EXOPULSE Mollii Suit Stimulation Sham
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
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.
Active Comparator: EXOPULSE Mollii Suit Stimulation Active
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance using Berg Balance Scale (BBS)
Time Frame: To be assessed at baseline.
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)
Time Frame: To be assessed at week 2.
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)
Time Frame: To be assessed at week 4.
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)
Time Frame: To be assessed at week 8.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Score for spasticity.
Time Frame: This to be assessed at baseline, then at week 2, week 4 and week 8.
Spasticity will be measured using a visual analog score from 0 to 10, 0 being no spasticity and 10 being the worst possible spasticity.
This to be assessed at baseline, then at week 2, week 4 and week 8.
Visual Analog Score for pain.
Time Frame: This to be assessed at baseline, then at week 2, week 4 and week 8.
Pain will be measured using a visual analog score from 0 to 10, 0 being no pain, to 10 being the worst possible pain.
This to be assessed at baseline, then at week 2, week 4 and week 8.
Muscle tone.
Time Frame: This to be assessed at baseline, then at week 2, week 4 and week 8.
Muscle tone will be evaluated by the Modified Ashworth Scale (MAS). Scores will range from 0 to 4, 0 being no increase or normal muscle tone, to 4 being rigidity in flexion or extension of muscles.
This to be assessed at baseline, then at week 2, week 4 and week 8.
Fall Risk
Time Frame: Two weeks after the second stimulation and 4 weeks later at the end of phase 2.

Fall risk will be assessed using the Falls Efficacy Scale-International scale. It is a 16-item scale, including a range of functional activities, that assesses the perceived risk of falling, using a score that will range from 1 to 4, 1 being not at all concerned to 4 being very concerned.

Items are summed to a total score that will range from a minimum of 16 (no concern about falling) to a maximum of 64 (severe concern about falling).
Two weeks after the second stimulation and 4 weeks later at the end of phase 2.
Body Mass Index (BMI)
Time Frame: Baseline
The weight and height will be combined to report BMI in kg/m^2. BMI of 35 kg/m^2 or more will be used as an exclusion criterion for the study.
Baseline
Weight
Time Frame: Baseline.
The patient weight will be measured and recorded in kilograms.
Baseline.
EQ-5D-5L: EuroQol 5 Dimensions 5 Levels Quality of Life Questionnaire
Time Frame: Two weeks after the second stimulation and 4 weeks later at the end of phase 2.
Two weeks after the second stimulation and 4 weeks later at the end of phase 2.
Overall Clinical improvement
Time Frame: This to be assessed at baseline, then at week 2, and week 8.

Evaluation of overall Clinical improvement will be done using the 7-point Clinical Global Impression (CGI). Patient will fill a questionnaire that will address their clinical situation as follows:

Very much improved. Much improved. Slightly improved. No change. Slightly worse. Much worse. Very much worse.

The score will range from 1-7, 1 being the best clinical outcome and 7 the worst.
This to be assessed at baseline, then at week 2, and week 8.
Blinding Questionnaire
Time Frame: This to be assessed at baseline, then at week 2.

Evaluation of patient's blinding to the type of stimulation in the crossover trial periods using a dedicated questionnaire. Patients will be asked whether they think they received the sham or active stimulation.

No scale will be used for this measure.
This to be assessed at baseline, then at week 2.
Visual Analog Score for fatigue
Time Frame: This to be assessed at baseline, then at week 2, week 4 and week 8.
Fatigue will be measured using a visual analog score from 0 to 10, 0 being no fatigue, to 10 being the worst possible fatigue.
This to be assessed at baseline, then at week 2, week 4 and week 8.
Height
Time Frame: Baseline
The patient height will be measured and recorded in centimeters.
Baseline
Time Up and Go (TUG)
Time Frame: This to be assessed at baseline, then at week 2, week 4 and week 8.
Patients have to stand up from a chair when they hear the verbal instruction "go", walk a distance of 3 meters, turn around, walk back to the chair and sit down. Timing starts with the verbal instruction "go' and stops when the patients return to the seated position. The score consists of the time taken to complete the test activity, measured in seconds.
This to be assessed at baseline, then at week 2, week 4 and week 8.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheikh Shakhbout Medical City

Investigators

  • Principal Investigator: Naji J Riachi, MD, SSMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2023

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

December 2, 2024

Study Registration Dates

First Submitted

November 20, 2023

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXOSTROKE2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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