Effects of Using the Electrodress Mollii on Spasticity

Study Overview
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Brief Summary
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Spasticity is a common manifestation of lesions of central motor pathways, such as after stroke, traumatic brain or spinal cord injury and in cerebral palsy and is associated with increased impairments and disabilities. Spasticity may be associated with pain and contractures, caused by muscle weakness, reduced muscle length and volume that add to the disability.Treatments of spasticity comprise physical therapy, pharmacological agents and surgical treatment. Recently, a systematic review concluded that transcutaneous, electric nerve stimulation may have beneficial effects on spasticity and activity performance after stroke, which lends support to the new treatment method Mollii, which will be evaluated in this study.The Mollii suit provides electric stimulation through multiple electrodes places in a tight fitting suit. This study relates to the clinical trials performed at the University department of rehabilitation medicine at Danderyd Hospital in Stockholm and comprises an initial study of effects on spasticity (Mechanical substudy) and a following, exploratory treatment trial (Clinical substudy) in patients with spasticity after stroke.

Detailed Description
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Spasticity is a common manifestation of lesions of central motor pathways, such as after stroke, traumatic brain or spinal cord injury and in cerebral palsy and is associated with increased impairments and disabilities. Spasticity may be associated with pain and contractures, caused by muscle weakness, reduced muscle length and volume that add to the disability.Treatments of spasticity comprise physical therapy, pharmacological agents and surgical treatment. Recently, a systematic review concluded that transcutaneous, electric nerve stimulation may have beneficial effects on spasticity and activity performance after stroke, which lends support to the new treatment method Mollii, which will be evaluated in this study.The Mollii method has been developed by Inervetions, which is a small Swedish med-tech company, and represents an innovative approach for non-invasive electro-stimulation to reduce spasticity and improve motor function. The theoretical background of this treatment method primarily refers to the concept of reciprocal inhibition, i.e. that sensory input from a muscle may inhibit the activation of an antagonistic muscle. Thus, the application of Mollii aims at stimulating a muscle, e.g. the anterior tibial muscle of the lower leg in order to reduce reflex mediated over-activity, i.e. spasticity, in calf muscles by inducing reciprocal inhibition.

Official Title
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Effects of Using the Electrodress Mollii to Reduce Spasticity and Enhance Functioning After Stroke.

Conditions
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Spasticity, Muscle, Stroke, Electric Stimulation Therapy

Intervention / Treatment
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* Device: Mollii


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible participants had suffered a stroke > 12 months earlier were living with hemiplegia affecting the right or the left side of the body including both upper and lower extremity function were able to walk with assistance or independently according to the Functional Ambulatory Categories (Holden 1984) with a score of 2-5 activity in upper extremity was limited according to the Action Research Arm test (ARAT) (Nordin 2014) but could perform a grasp and grip movement were > 17 years old, able to understand instructions as well as written and oral study information and could express informed consent Exclusion Criteria: no detected neural component exceeding the cut off for spasticity according to the Neuroflexor (> 3. 4 Newton) in the wrist flexors contractures not compatible with performing the Neurofexor test or walking any other disorder with an impact on sensorimotor function any other severe concomitant disease (such as cancer, cardiovascular, inflammatory or psychiatric disease), uncontrolled epilepsy or blood pressure, major surgery during the last year, any implanted medical devices pregnancy BMI>35

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Mechanism substudy: explorative single group design with three different stimulation paradigms provided to all participants by double blinded randomisation. Clinical substudy: explorative single group design.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention in a Mechanism and a Clinical substudy<br>Mechanism substudy: 3 trial sessions ( electrodes set to 1) 20 Hz, 2) 30 Hz, 3) 0 Hz (placebo). Patients and datacollectors were blinded in terms of the randomised order of the treatment at each of the 3 trial sessions ( electrodes set to 1) 20 Hz, 2) 30 Hz, 3) 0 Hz (placebo). Clinical substudy: Use of the fitted and individually set body suit, Mollii, in the home setting for 6 weeks | Device: Mollii<br>* The Mollii method is provided in a tight fitting, whole body suit with multiple electrodes that can be set individually. The Mollii method uses low frequencies and low intensities that evokes sensory input but does not directly elicit muscle contractions. The theoretical background of this treatment method primarily refers to the concept of reciprocal inhibition, i.e. that sensory input from a muscle may inhibit the activation of an antagonistic muscle through the activation of the disynaptic reciprocal Ia inhibitory pathway.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanism substudy and Clinical substudy: NeuroFlexor | Measure related to spasticity: The Neuroflexor device comprises a portable computer-controlled step motor system with a lever arm that generates constant velocity movements of the wrist or ankle. The passive resistive force of the wrist or ankle is recorded by a force transducer. The force is then analyzed off-line and the total resistance is separated into mechanical and a neural components using a neuro-biomechanical computerized model. NeuroFlexor neural component reflecting stretch reflex mediated resistance, represents the main outcome. The NeuroFlexor hand (used in mechanism and clinical substudy) and foot module (used in mechansim substudy only) is a valid method that quantifies and distinguishes the genuine spasticity and the mechanical contributions (viscoelastic and soft tissue components) of the resistance opposing a passive stretch. | Mechanism study: To assess change, NeuroFlexor data is recorded before, during and 10 minutes after treatment at each session. Clinical study: To assess change Neuroflexor data is collected before and after the 6 week intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanism substudy: Surface electromyography | Measure related to spasticity: Surface electromyography (sEMG) signal of spastic muscles in the upper and lower limb (flexor carpi radialis, medial gastrocnemius and soleus muscles). | To assess change sEMG are assessed before and after 60 min of treatment at each session. | 
| Mechanism substudy: Modified Ashworth scale: | Clinical assessment of spasticity on a 5 point scale ranging from 0= no spasticity to 5= rigidity | Before and after 60 min of treatment at each session to assess change | 
| Mechanism substudy: Semi structured interview | To assess perceived effects of each intervention | During the 60 min of treatment at each session | 
| Clinical substudy: the Fugl-Meyer scale | Clinical assessment of motor sensory function of the upper (min 0 p and max 126p) and lower extremity (min 0 p and max 86p). Max point indicates no detected impairment. | Before and after the 6 week intervention to assess change | 
| Clinical substudy: Modified Ashworth scale | Clinical assessment of spasticity on a 5 point scale ranging from 0= no spasticity to 5= rigidity | Before and after the 6 week intervention to assess change | 
| Clinical substudy: Barthel Index | Assessment of self-care and mobility (min 0 p and max 100p). Max point indicates independence | Before and after the 6 week intervention to assess change | 
| Clinical substudy: Berg balance scale | Clinical assessment of balance (max 56p). Max point indicate no limitations in balance. | Before and after the 6 week intervention to assess change | 
| Clinical substudy: Montreal Cognitive Assessment | Assessment of cognitive function (min 0 p and max 30p). Max point indicate no impairment. | Before and after the 6 week intervention to assess change | 
| Clinical substudy: Action Research Arm Test | Clinical assessment of activity in upper extremity (max 57 p). Max point indicate no limitation. | Before and after the 6 week intervention to assess change | 
| Clinical substudy: A digital hand dynamometer | Clinical assessment of grip strength in kilograms. | Before and after the 6 week intervention to assess change | 
| Clinical substudy: 10 meter walk test | Clinical assessment of walking speed (m/s) | Before and after the 6 week intervention to assess change | 
| Clinical substudy: 6 min walk test | Clinical assessment of walking endurance (meters) | Before and after the 6 week intervention to assess change | 
| Clinical substudy: Functional Ambulation Category | Assessment of indedence in walking (min 0 p and max 5p) Max point indicate independence | Before and after the 6 week intervention to assess change | 
| Clinical substudy: Stroke Impact Scale | Self-perceived functioning and disability (min 0 p and max 100p/item). Max point indicate no perceived disability. | Before and after the 6 week intervention to assess change | 
| Clinical substudy: Weekly semistructured telephone interview | To assess compliance, perceived effects and adverse events. | Weekly during the 6 week intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spasticity, Stroke, Functioning, Disability, Intervention, electrical stimulation therapy