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Completed

NCT Number: NCT04322825

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

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.

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Key information

Conditions

Spastic Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

hospital of Hvidovre

Hvidovre, 2650, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TENS incorporated into the Mollii suit

Device

trans cutaneous electric stimulation,

Primary outcomes

  1. modified ashworth scale

    Time frame: 24 weeks

    spasticity evaluation from 0 (best) to 4 (worst) in modified ashworth scale

Secondary outcomes

  1. Goal Attainment Scale

    Time frame: 24 weeks

    smart goals from -2 (worst) to +2 (best)

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Eurostars

Registry information

Official study title

Mollii - Personalized Suit for Treatment of Spasticity, GFMCS3-5

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 26, 2020
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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