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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04076878
Study type Interventional
Source Danderyd Hospital
Contact
Status Completed
Phase N/A
Start date August 15, 2017
Completion date February 1, 2019

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