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

NCT06302790 | Recruiting

• 1 other identifier: AcuteMolliiSuitEffects
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Mollii Suit; Cerebral Palsy

Keywords

cerebral palsy; mollii suit; muscle tone; balance

Outcome Measures

Primary Outcomes (4)

• Gross Motor Function Classification System (GMFCS)

  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)

  The MTS assesses the muscle's response to stretch at given velocities.

  5 minutes

• Modifiye Modified Ashworth Scale (MAS)

  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

  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

Study Arms (3)

Molli Suit Apply Group (Device On)

ACTIVE COMPARATOR

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

Mollii Suit Placebo Group (Device Off)

PLACEBO COMPARATOR

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

Control Group

NO INTERVENTION

Children will be evaluated and the evaluations will be repeated 60 minutes later.

Interventions

Molli Suit Apply OTHER

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.

Molli Suit Apply Group (Device On); Mollii Suit Placebo Group (Device Off)

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Kırıkkale University: lead
• Gazi University: collaborator

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Rubio-Zarapuz A, Apolo-Arenas MD, Clemente-Suarez VJ, Costa AR, Pardo-Caballero D, Parraca JA. Acute Effects of a Session with The EXOPULSE Mollii Suit in a Fibromyalgia Patient: A Case Report. Int J Environ Res Public Health. 2023 Jan 26;20(3):2209. doi: 10.3390/ijerph20032209.

  PMID: 36767576 RESULT

• Pennati GV, Bergling H, Carment L, Borg J, Lindberg PG, Palmcrantz S. Effects of 60 Min Electrostimulation With the EXOPULSE Mollii Suit on Objective Signs of Spasticity. Front Neurol. 2021 Oct 15;12:706610. doi: 10.3389/fneur.2021.706610. eCollection 2021.

  PMID: 34721255 RESULT

• Flodstrom C, Viklund Axelsson SA, Nordstrom B. A pilot study of the impact of the electro-suit Mollii(R) on body functions, activity, and participation in children with cerebral palsy. Assist Technol. 2022 Jul 4;34(4):411-417. doi: 10.1080/10400435.2020.1837288. Epub 2021 Mar 29.

  PMID: 33151822 RESULT

• Nordstrom B, Prellwitz M. A pilot study of children and parents experiences of the use of a new assistive device, the electro suit Mollii. Assist Technol. 2021 Sep 3;33(5):238-245. doi: 10.1080/10400435.2019.1579267. Epub 2019 Apr 4.

  PMID: 30945989 RESULT

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Kübra Uğurlu

CONTACT

+905077295353; kubra.ozdamar06@gmail.com

Bülent Elbasan

CONTACT

+905324672923; bulentelbasan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The statistician in the study and the physiotherapist performing the evaluation will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)