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

Hvidovre University Hospital31 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spastic Cerebral Palsy

Interventions

TENS incorporated into the Mollii suitDEVICE

trans cutaneous electric stimulation,

Eligibility

Sex: ALLMin age: 4 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

hospital of Hvidovre

Hvidovre, Denmark

Outcomes

Primary Outcomes

modified ashworth scale

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

Time frame: 24 weeks

Secondary Outcomes

Goal Attainment Scale

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

Time frame: 24 weeks

Data from ClinicalTrials.gov

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