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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04322825
Enrollment
31
Registered
2020-03-26
Start date
2017-06-01
Completion date
2019-07-01
Last updated
2023-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spastic Cerebral Palsy

Keywords

Mollii suit;, Goal Attainment Scale;, Reciprocal inhibition;, modified ashworth scale,, trans cutaneous electric stimulation, TENS, Spasticity reduction,

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.

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.

Interventions

DEVICETENS incorporated into the Mollii suit

trans cutaneous electric stimulation,

Sponsors

Eurostars
CollaboratorOTHER
Hvidovre University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

prospective cohort study

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
modified ashworth scale24 weeksspasticity evaluation from 0 (best) to 4 (worst) in modified ashworth scale

Secondary

MeasureTime frameDescription
Goal Attainment Scale24 weekssmart goals from -2 (worst) to +2 (best)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026