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

Hvidovre University Hospital

Status: Completed

Conditions: Spastic Cerebral Palsy

Treatments: Device: TENS incorporated into the Mollii suit

Study type: Interventional

Funder types: Other

Identifiers

NCT04322825

H-17004467

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

intervention

Experimental group

Description:

24 weeks of TENS

Treatment:

Device: TENS incorporated into the Mollii suit