Effects of Using the Electrodress Mollii on Spasticity

NCT04076878 | Completed

• 1 other identifier: Mollii for spasticity
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Spasticity, Muscle; Stroke; Electric Stimulation Therapy

Keywords

Spasticity; Stroke; Functioning; Disability; Intervention; electrical stimulation therapy

Outcome Measures

Primary Outcomes (1)

• Mechanism substudy and Clinical substudy: NeuroFlexor

  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.

  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 (15)

• Mechanism substudy: Surface electromyography

  To assess change sEMG are assessed before and after 60 min of treatment at each session.

• Mechanism substudy: Modified Ashworth scale:

  Before and after 60 min of treatment at each session to assess change

• Mechanism substudy: Semi structured interview

  During the 60 min of treatment at each session

• Clinical substudy: the Fugl-Meyer scale

  Before and after the 6 week intervention to assess change

• Clinical substudy: Modified Ashworth scale

  Before and after the 6 week intervention to assess change

Study Arms (1)

Intervention in a Mechanism and a Clinical substudy

EXPERIMENTAL

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

Device: Mollii

Interventions

Mollii DEVICE

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.

Intervention in a Mechanism and a Clinical substudy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danderyd Hospital: lead

Study Sites (1)

Department of Rehabilitation Medicine, Danderyd Hospital

Danderyd, Stockholm County, SE18288, Sweden

Location

Related Publications (5)

• 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.

  PMID: 24850135 BACKGROUND

• 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.

  PMID: 23695917 BACKGROUND

• 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.

  PMID: 21490269 BACKGROUND

• 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.

  PMID: 34721255 DERIVED

• 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.

  PMID: 32778118 DERIVED

MeSH Terms

Conditions

Muscle Spasticity; Stroke

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Susanne Palmcrantz, PhD

  Danderyd Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: September 3, 2019
• Study Start: August 15, 2017
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: September 3, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)