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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2019-07-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Spastic Cerebral Palsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective cohort study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intervention

24 weeks of TENS

Group Type EXPERIMENTAL

TENS incorporated into the Mollii suit

Intervention Type DEVICE

trans cutaneous electric stimulation,

Interventions

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TENS incorporated into the Mollii suit

trans cutaneous electric stimulation,

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No