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Mollii - Personalized Suit for Treatment of Spasticity, GFMCS 3-5

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ClinicalTrials.gov Identifier: NCT04322825
Recruitment Status : Completed
First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
Eurostars
Information provided by (Responsible Party):
christian wong, Hvidovre University Hospital

Study Description
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Brief Summary:
The objective of this study was to examine the effect on spasticity and function of multifocal transcutaneous electrical stimulation incorporated in a 2-piece (Mollii) suit.

Condition or disease Intervention/treatment Phase
Spastic Cerebral Palsy Device: TENS incorporated into the Mollii suit Not Applicable

Detailed Description:
In this prospective cohort study, the participants (children with predominantly spastic CP, GFMCS 3-5) wore the suit for 1 hour every second day for 24 weeks. The investigators evaluated level of spasticity using the modified Ashworth scale (MAS) and other related measures before initiation, after 4, 12, and 24 weeks. Two motor related smart goals were defined and evaluated by the goal attainment scale (GAS). GMFM-66 and posture and postural ability scale (PPAS) were performed.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: prospective cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mollii - Personalized Suit for Treatment of Spasticity, GFMCS3-5
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: intervention
24 weeks of TENS
 Device: TENS incorporated into the Mollii suit
trans cutaneous electric stimulation,


Outcome Measures
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Primary Outcome Measures :
  1. modified ashworth scale [ Time Frame: 24 weeks ]
    spasticity evaluation from 0 (best) to 4 (worst) in modified ashworth scale


Secondary Outcome Measures :
  1. Goal Attainment Scale [ Time Frame: 24 weeks ]
    smart goals from -2 (worst) to +2 (best)


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- cerebral palsy with spastic disease, GMFCS 3-5.

Exclusion Criteria:

  • other disorders affecting the sensorimotor functions without spasticity,
  • implanted electric medical devices,
  • BMI>35
  • other severe concomitant diseases such as cancer, cardiovascular, inflammatory, psychiatric disease, medical dysregulated epilepsy or hypertension.
Contacts and Locations
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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): NCT04322825


Locations
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Denmark
hospital of Hvidovre
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Eurostars
More Information
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Responsible Party: christian wong, consultant, clinical lecturer, PhD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT04322825    
Other Study ID Numbers: H-17004467
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: we are not permitted to share these data due to gpdr ruels

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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 christian wong, Hvidovre University Hospital:
Mollii suit;
Goal Attainment Scale;
Reciprocal inhibition;
 modified ashworth scale,
trans cutaneous electric stimulation, TENS
Spasticity reduction,
Additional relevant MeSH terms:
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Muscle Spasticity
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations