Department of Rehabilitation Medicine, Danderyd Hospital
Danderyd, Stockholm County, SE18288, Sweden
NCT Number: NCT04076878
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.
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All sexes
Interventional
Not applicable
Danderyd, Stockholm County, SE18288, Sweden
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.
Healthy volunteers accepted: No
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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.
Time frame: 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.
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.
Time frame: To assess change sEMG are assessed before and after 60 min of treatment at each session.
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).
Time frame: Before and after 60 min of treatment at each session to assess change
Clinical assessment of spasticity on a 5 point scale ranging from 0= no spasticity to 5= rigidity
Time frame: During the 60 min of treatment at each session
To assess perceived effects of each intervention
Time frame: Before and after the 6 week intervention to assess change
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.
Time frame: Before and after the 6 week intervention to assess change
Clinical assessment of spasticity on a 5 point scale ranging from 0= no spasticity to 5= rigidity
Time frame: Before and after the 6 week intervention to assess change
Assessment of self-care and mobility (min 0 p and max 100p). Max point indicates independence
Time frame: Before and after the 6 week intervention to assess change
Clinical assessment of balance (max 56p). Max point indicate no limitations in balance.
Time frame: Before and after the 6 week intervention to assess change
Assessment of cognitive function (min 0 p and max 30p). Max point indicate no impairment.
Time frame: Before and after the 6 week intervention to assess change
Clinical assessment of activity in upper extremity (max 57 p). Max point indicate no limitation.
Time frame: Before and after the 6 week intervention to assess change
Clinical assessment of grip strength in kilograms.
Time frame: Before and after the 6 week intervention to assess change
Clinical assessment of walking speed (m/s)
Time frame: Before and after the 6 week intervention to assess change
Clinical assessment of walking endurance (meters)
Time frame: Before and after the 6 week intervention to assess change
Assessment of indedence in walking (min 0 p and max 5p) Max point indicate independence
Time frame: Before and after the 6 week intervention to assess change
Self-perceived functioning and disability (min 0 p and max 100p/item). Max point indicate no perceived disability.
Time frame: Weekly during the 6 week intervention
To assess compliance, perceived effects and adverse events.
Danderyd Hospital
Other
Effects of Using the Electrodress Mollii to Reduce Spasticity and Enhance Functioning After Stroke.
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