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

Not Applicable

Recruiting

• Conditions: Mollii Suit; Cerebral Palsy
• Interventions: Other: Molli Suit Apply

• Registration Number: NCT06302790
• Lead Sponsor: Kırıkkale University

Brief Summary

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.

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 Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-01
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-04
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-03-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Molli Suit Apply Group (Device On)	Molli Suit Apply	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.
Mollii Suit Placebo Group (Device Off)	Molli Suit Apply	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.

Primary Outcome Measures

Name	Time	Method
NMC Tests with Seansamove Sensbalance	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.
Gross Motor Function Classification System (GMFCS)	1 Minute	Gross Motor Function Classification System (GMFCS) developed by R. Palisano will be used in the classification of motor function.
Modifiye Modified Ashworth Scale (MAS)	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.
Modified Tardiue Scale (MTS)	5 minutes	The MTS assesses the muscle's response to stretch at given velocities.

Trial Locations

Locations (1)

Gazi University; 🇹🇷 Ankara, Turkey