Effects of Using the Electrodress Mollii on Spasticity

Danderyd Hospital

Status: Completed

Conditions: Spasticity, Muscle; Electric Stimulation Therapy; Stroke

Treatments: Device: Mollii

Study type: Interventional

Funder types: Other

Identifiers

NCT04076878

Mollii for spasticity

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Intervention in a Mechanism and a Clinical substudy

Experimental group

Description:

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

Treatment:

Device: Mollii