Spastic, Spasticity, Muscle, Stroke
Conditions
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.
Interventions
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.
Sponsors
Sheikh Shakhbout Medical City
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Balance using Berg Balance Scale (BBS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Score for pain. | 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. |
| 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. | 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. |
| Blinding Questionnaire | 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. |
| Visual Analog Score for fatigue | 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. |
| Visual Analog Score for spasticity. | 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. |
| Fall Risk | 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). |
| Weight | Baseline. | The patient weight will be measured and recorded in kilograms. |
| Height | Baseline | The patient height will be measured and recorded in centimeters. |
| Time Up and Go (TUG) | 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. |
| Body Mass Index (BMI) | 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. |
| Muscle tone. | 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. |
Countries
United Arab Emirates
Contacts
Primary ContactNaji J Riachi, MD
Backup ContactHasan M Jaber, Bsc
Outcome results
None listed