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

Primary Purpose

Spastic Cerebral Palsy

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

TENS incorporated into the Mollii suit

About this trial

This is an interventional treatment trial for Spastic Cerebral Palsy focused on measuring Mollii suit;, Goal Attainment Scale;, Reciprocal inhibition;, modified ashworth scale,, trans cutaneous electric stimulation, TENS, Spasticity reduction,

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

hospital of Hvidovre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intervention

Arm Description

24 weeks of TENS

Outcomes

Primary Outcome Measures

modified ashworth scale

spasticity evaluation from 0 (best) to 4 (worst) in modified ashworth scale

Secondary Outcome Measures

Goal Attainment Scale

smart goals from -2 (worst) to +2 (best)

Full Information

NCT ID

NCT04322825

First Posted

November 1, 2019

Last Updated

January 4, 2023

Sponsor

Hvidovre University Hospital

Collaborators

Eurostars

1. Study Identification

Unique Protocol Identification Number

NCT04322825

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

July 1, 2019 (Actual)

Study Completion Date

July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hvidovre University Hospital

Collaborators

Eurostars

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spastic Cerebral Palsy

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

prospective cohort study

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

intervention

Arm Type

Experimental

Arm Description

24 weeks of TENS

Intervention Type

Device

Intervention Name(s)

TENS incorporated into the Mollii suit

Intervention Description

trans cutaneous electric stimulation,

Primary Outcome Measure Information:

Title

modified ashworth scale

Description

spasticity evaluation from 0 (best) to 4 (worst) in modified ashworth scale

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Goal Attainment Scale

Description

smart goals from -2 (worst) to +2 (best)

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

hospital of Hvidovre

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

we are not permitted to share these data due to gpdr ruels

Learn more about this trial

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

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