Trials / Completed
CompletedNCT04322825
Mollii - Personalized Suit for Treatment of Spasticity, GFMCS 3-5
Mollii - Personalized Suit for Treatment of Spasticity, GFMCS3-5
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Hvidovre University Hospital · Academic / Other
- Sex
- All
- Age
- 4 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TENS incorporated into the Mollii suit | trans cutaneous electric stimulation, |
Timeline
- Start date
- 2017-06-01
- Primary completion
- 2019-07-01
- Completion
- 2019-07-01
- First posted
- 2020-03-26
- Last updated
- 2023-01-06
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04322825. Inclusion in this directory is not an endorsement.