Clinical trial NCT04076878: Effects of Using the Electrodress Mollii on Spasticity
Official title: Effects of Using the Electrodress Mollii to Reduce Spasticity and Enhance Functioning After Stroke.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spasticity, Muscle
Stroke
Electric Stimulation Therapy
Keywords: Spasticity
Stroke
Functioning
Disability
Intervention
electrical stimulation therapy
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mechanism substudy and Clinical substudy: NeuroFlexor
timeFrame: 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 outcomes:
measure: Mechanism substudy: Surface electromyography
timeFrame: To assess change sEMG are assessed before and after 60 min of treatment at each session.
measure: Mechanism substudy: Modified Ashworth scale:
timeFrame: Before and after 60 min of treatment at each session to assess change
measure: Mechanism substudy: Semi structured interview
timeFrame: During the 60 min of treatment at each session
measure: Clinical substudy: the Fugl-Meyer scale
timeFrame: Before and after the 6 week intervention to assess change
measure: Clinical substudy: Modified Ashworth scale
timeFrame: Before and after the 6 week intervention to assess change
measure: Clinical substudy: Barthel Index
timeFrame: Before and after the 6 week intervention to assess change
measure: Clinical substudy: Berg balance scale
timeFrame: Before and after the 6 week intervention to assess change
measure: Clinical substudy: Montreal Cognitive Assessment
timeFrame: Before and after the 6 week intervention to assess change
measure: Clinical substudy: Action Research Arm Test
timeFrame: Before and after the 6 week intervention to assess change
measure: Clinical substudy: A digital hand dynamometer
timeFrame: Before and after the 6 week intervention to assess change
measure: Clinical substudy: 10 meter walk test
timeFrame: Before and after the 6 week intervention to assess change
measure: Clinical substudy: 6 min walk test
timeFrame: Before and after the 6 week intervention to assess change
measure: Clinical substudy: Functional Ambulation Category
timeFrame: Before and after the 6 week intervention to assess change
measure: Clinical substudy: Stroke Impact Scale
timeFrame: Before and after the 6 week intervention to assess change
measure: Clinical substudy: Weekly semistructured telephone interview
timeFrame: Weekly during the 6 week intervention
Other outcomes:
Locations:
city: Danderyd
country: Sweden
facility: Department of Rehabilitation Medicine, Danderyd Hospital
state: Stockholm
Study officials:
affiliation: Danderyd Hospital
name: Susanne Palmcrantz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gaverth J, Eliasson AC, Kullander K, Borg J, Lindberg PG, Forssberg H. Sensitivity of the NeuroFlexor method to measure change in spasticity after treatment with botulinum toxin A in wrist and finger muscles. J Rehabil Med. 2014 Jul;46(7):629-34. doi: 10.2340/16501977-1824.
citation: Gaverth J, Sandgren M, Lindberg PG, Forssberg H, Eliasson AC. Test-retest and inter-rater reliability of a method to measure wrist and finger spasticity. J Rehabil Med. 2013 Jul;45(7):630-6. doi: 10.2340/16501977-1160.
citation: Lindberg PG, Gaverth J, Islam M, Fagergren A, Borg J, Forssberg H. Validation of a new biomechanical model to measure muscle tone in spastic muscles. Neurorehabil Neural Repair. 2011 Sep;25(7):617-25. doi: 10.1177/1545968311403494. Epub 2011 Apr 13.
citation: Pennati GV, Bergling H, Carment L, Borg J, Lindberg PG, Palmcrantz S. Effects of 60 Min Electrostimulation With the EXOPULSE Mollii Suit on Objective Signs of Spasticity. Front Neurol. 2021 Oct 15;12:706610. doi: 10.3389/fneur.2021.706610. eCollection 2021.
citation: Palmcrantz S, Pennati GV, Bergling H, Borg J. Feasibility and potential effects of using the electro-dress Mollii on spasticity and functioning in chronic stroke. J Neuroeng Rehabil. 2020 Aug 10;17(1):109. doi: 10.1186/s12984-020-00740-z.