Mollii - Personalized Suit for Treatment of Spasticity, GFMCS 3-5
- Conditions
- Spastic Cerebral Palsy
- Interventions
- Device: TENS incorporated into the Mollii suit
- Registration Number
- NCT04322825
- Lead Sponsor
- Hvidovre University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- cerebral palsy with spastic disease, GMFCS 3-5.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description intervention TENS incorporated into the Mollii suit 24 weeks of TENS
- Primary Outcome Measures
Name Time Method modified ashworth scale 24 weeks spasticity evaluation from 0 (best) to 4 (worst) in modified ashworth scale
- Secondary Outcome Measures
Name Time Method Goal Attainment Scale 24 weeks smart goals from -2 (worst) to +2 (best)
Trial Locations
- Locations (1)
hospital of Hvidovre
🇩🇰Hvidovre, Denmark