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Effects of Using the Electrodress Mollii on Spasticity

Sponsored by Danderyd Hospital

About this trial

Last updated 6 years ago

Study ID

Mollii for spasticity

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 7 years ago

What is this trial 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.

What are the participation requirements?

Yes

Inclusion Criteria

- 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

No

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