NCT04322825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
Last Updated

January 6, 2023

Status Verified

January 1, 2023

Enrollment Period

2.1 years

First QC Date

November 1, 2019

Last Update Submit

January 4, 2023

Conditions

Spastic Cerebral Palsy

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • modified ashworth scale

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

    24 weeks

Secondary Outcomes (1)

  • Goal Attainment Scale

    24 weeks

Study Arms (1)

intervention

EXPERIMENTAL

24 weeks of TENS

Device: TENS incorporated into the Mollii suit

Interventions

TENS incorporated into the Mollii suitDEVICE

trans cutaneous electric stimulation,

intervention

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- cerebral palsy with spastic disease, GMFCS 3-5.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

hospital of Hvidovre

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: prospective cohort study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

November 1, 2019

First Posted

March 26, 2020

Study Start

June 1, 2017

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

January 6, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

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

Locations

DK(1)