Examination of the Acute Effect of Mollii Suit in Children With Cerebral Palsy

March 4, 2024 updated by: Kübra Uğurlu, Kırıkkale University

Examination of the Acute Effect of Mollii Suit in Children With Cerebral Palsy: A Double-Blind Randomized Controlled Study

The aim of our study is to examine the acute effect of Mollii Suit application on balance and muscle tone problems in children with spastic cerebral palsy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cerebral Palsy (CP) is the most common developmental disorder in childhood. Individuals' independence in daily living activities and participation in education, games, social and community activities are restricted. Technology applications in the field of rehabilitation are gaining momentum. EXOPULSE Mollii Suit method, one of the newest rehabilitation technology products, is a non-invasive neuromodulation approach with a garment that covers the whole body and electrodes placed inside. Designed to improve motor function by reducing spasticity and pain, the method is based on the principle of reciprocal inhibition, which occurs by stimulating the antagonist of a spastic muscle at low frequencies and intensities. Therefore, the aim of our study is to examine the acute effect of Mollii Suit application on balance and muscle tone problems in children with spastic cerebral palsy.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • volunteering to participate in the study
  • Having a diagnosis of spastic CP
  • 1 or 2 on the Gross Motor Classification System (GMFCS)
  • Between the ages of 4-18.

Exclusion Criteria:

  • Having GMFCS 3,4,5
  • Botulinum Toxin A performed before 3 months or surgical intervention before 6 months
  • Having an invasive medical pump (baclofen, insulin, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Molli Suit Apply Group (Device On)
Evaluations will be made before the children are dressed in the Mollii Suit, and the evaluations will be repeated after the children are dressed and practiced for 60 minutes.
Other: Molli Suit Apply
Exopulse Mollii Suit is a neuromodulation application that has been extensively evaluated and is a reliable technique in patients with spasticity. Unlike many neurostimulation techniques that focus only on symptomatic muscles, Suit relieves spasticity and associated pain by stimulating the weakened antagonist of the spastic muscle. Its wearable structure is designed to manage spasticity and associated pain in both upper and lower extremities.
Placebo Comparator: Mollii Suit Placebo Group (Device Off)
Evaluations will be made before the children are dressed in the Mollii Suit, and the evaluations will be repeated after the children are dressed and applied for 60 minutes with the device in off mode.
Other: Molli Suit Apply
Exopulse Mollii Suit is a neuromodulation application that has been extensively evaluated and is a reliable technique in patients with spasticity. Unlike many neurostimulation techniques that focus only on symptomatic muscles, Suit relieves spasticity and associated pain by stimulating the weakened antagonist of the spastic muscle. Its wearable structure is designed to manage spasticity and associated pain in both upper and lower extremities.
No Intervention: Control Group
Children will be evaluated and the evaluations will be repeated 60 minutes later.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross Motor Function Classification System (GMFCS)
Time Frame: 1 Minute
Gross Motor Function Classification System (GMFCS) developed by R. Palisano will be used in the classification of motor function.
1 Minute
Modified Tardiue Scale (MTS)
Time Frame: 5 minutes
The MTS assesses the muscle's response to stretch at given velocities.
5 minutes
Modifiye Modified Ashworth Scale (MAS)
Time Frame: 5 Minutes
The modified Ashworth scale (MAS), has been applied in clinical practice and research as a measure of spasticity. The modified Ashworth scale purpose is to grade muscle spasticity.
5 Minutes
NMC Tests with Seansamove Sensbalance
Time Frame: 5 minutes
NMC Tests means Neuro Muscular Control tests, and it consists of a number of fully adjustable balance tests. The software calculates up to what point the person is able to perform within the outlines of the exercise, and it will give a score per test. The tests and their duration can be adjusted. Individually applicable and very handy. Once it is adjusted, the same test can be repeated by just pushing a button. Time and results are easy to compare with previous tests.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kırıkkale University

Collaborators

Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AcuteMolliiSuitEffects

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Palsy

Clinical Trials on Molli Suit Apply

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe