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NCT04322825 Clinical Trial

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

Spastic Cerebral Palsy Clinical Trial

Official title:
Mollii - Personalized Suit for Treatment of Spasticity, GFMCS3-5

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04322825
Other study ID # H-17004467
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date July 1, 2019

Study information
Verified date January 2023
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 31
Est. completion date July 1, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers No
Gender All
Age group 4 Years to 18 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• TENS incorporated into the Mollii suit
trans cutaneous electric stimulation,

Locations
Country Name City State
Denmark hospital of Hvidovre Hvidovre

Sponsors (2)
Lead Sponsor Collaborator
Hvidovre University Hospital Eurostars

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary modified ashworth scale spasticity evaluation from 0 (best) to 4 (worst) in modified ashworth scale 24 weeks
Secondary Goal Attainment Scale smart goals from -2 (worst) to +2 (best) 24 weeks
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