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Effects of Using the Electrodress Mollii on Spasticity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04076878
Recruitment Status : Completed
First Posted : September 3, 2019
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Susanne Palmcrantz, Danderyd Hospital

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.

Condition or disease Intervention/treatment Phase
Spasticity, Muscle Stroke Electric Stimulation Therapy Device: Mollii Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Using the Electrodress Mollii to Reduce Spasticity and Enhance Functioning After Stroke.
Actual Study Start Date : August 15, 2017
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 1, 2019

Arm Intervention/treatment
Experimental: 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

Device: 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.




Primary Outcome Measures :
  1. Mechanism substudy and Clinical substudy: NeuroFlexor [ Time Frame: 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. ]
    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.


Secondary Outcome Measures :
  1. Mechanism substudy: Surface electromyography [ Time Frame: To assess change sEMG are assessed before and after 60 min of treatment at each session. ]
    Measure related to spasticity: Surface electromyography (sEMG) signal of spastic muscles in the upper and lower limb (flexor carpi radialis, medial gastrocnemius and soleus muscles).

  2. Mechanism substudy: Modified Ashworth scale: [ Time Frame: Before and after 60 min of treatment at each session to assess change ]
    Clinical assessment of spasticity on a 5 point scale ranging from 0= no spasticity to 5= rigidity

  3. Mechanism substudy: Semi structured interview [ Time Frame: During the 60 min of treatment at each session ]
    To assess perceived effects of each intervention

  4. Clinical substudy: the Fugl-Meyer scale [ Time Frame: Before and after the 6 week intervention to assess change ]
    Clinical assessment of motor sensory function of the upper (min 0 p and max 126p) and lower extremity (min 0 p and max 86p). Max point indicates no detected impairment.

  5. Clinical substudy: Modified Ashworth scale [ Time Frame: Before and after the 6 week intervention to assess change ]
    Clinical assessment of spasticity on a 5 point scale ranging from 0= no spasticity to 5= rigidity

  6. Clinical substudy: Barthel Index [ Time Frame: Before and after the 6 week intervention to assess change ]
    Assessment of self-care and mobility (min 0 p and max 100p). Max point indicates independence

  7. Clinical substudy: Berg balance scale [ Time Frame: Before and after the 6 week intervention to assess change ]
    Clinical assessment of balance (max 56p). Max point indicate no limitations in balance.

  8. Clinical substudy: Montreal Cognitive Assessment [ Time Frame: Before and after the 6 week intervention to assess change ]
    Assessment of cognitive function (min 0 p and max 30p). Max point indicate no impairment.

  9. Clinical substudy: Action Research Arm Test [ Time Frame: Before and after the 6 week intervention to assess change ]
    Clinical assessment of activity in upper extremity (max 57 p). Max point indicate no limitation.

  10. Clinical substudy: A digital hand dynamometer [ Time Frame: Before and after the 6 week intervention to assess change ]
    Clinical assessment of grip strength in kilograms.

  11. Clinical substudy: 10 meter walk test [ Time Frame: Before and after the 6 week intervention to assess change ]
    Clinical assessment of walking speed (m/s)

  12. Clinical substudy: 6 min walk test [ Time Frame: Before and after the 6 week intervention to assess change ]
    Clinical assessment of walking endurance (meters)

  13. Clinical substudy: Functional Ambulation Category [ Time Frame: Before and after the 6 week intervention to assess change ]
    Assessment of indedence in walking (min 0 p and max 5p) Max point indicate independence

  14. Clinical substudy: Stroke Impact Scale [ Time Frame: Before and after the 6 week intervention to assess change ]
    Self-perceived functioning and disability (min 0 p and max 100p/item). Max point indicate no perceived disability.

  15. Clinical substudy: Weekly semistructured telephone interview [ Time Frame: Weekly during the 6 week intervention ]
    To assess compliance, perceived effects and adverse events.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04076878


Locations
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Sweden
Department of Rehabilitation Medicine, Danderyd Hospital
Danderyd, Stockholm, Sweden, SE18288
Sponsors and Collaborators
Danderyd Hospital
Investigators
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Principal Investigator: Susanne Palmcrantz, PhD Danderyd Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Susanne Palmcrantz, Principal Investigator, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT04076878    
Other Study ID Numbers: Mollii for spasticity
First Posted: September 3, 2019    Key Record Dates
Last Update Posted: September 3, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Susanne Palmcrantz, Danderyd Hospital:
Spasticity
Stroke
Functioning
Disability
Intervention
electrical stimulation therapy
Additional relevant MeSH terms:
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Muscle Spasticity
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations