Effects of Using the Electrodress Mollii on Spasticity

NCT ID: NCT04076878

Last Updated: 2019-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-15
• Study Completion Date: 2019-02-01

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.

Conditions

Spasticity, Muscle; Stroke; Electric Stimulation Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention in a Mechanism and a Clinical substudy

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

Group Type: EXPERIMENTAL

Mollii

Intervention Type: 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.

Interventions

Mollii

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 Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danderyd Hospital

OTHER

Sponsor Role: lead

Responsible Party

Susanne Palmcrantz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susanne Palmcrantz, PhD

Role: PRINCIPAL_INVESTIGATOR

Danderyd Hospital

Locations

Department of Rehabilitation Medicine, Danderyd Hospital

Danderyd, Stockholm County, Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 24850135 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23695917 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21490269 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34721255 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32778118 (View on PubMed)

Other Identifiers

Mollii for spasticity

Identifier Type: -

Identifier Source: org_study_id