Clinical trial NCT06302790: Examination of the Acute Effect of Mollii Suit in Children With Cerebral Palsy
Official title: Examination of the Acute Effect of Mollii Suit in Children With Cerebral Palsy: A Double-Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mollii Suit
Cerebral Palsy
Keywords: cerebral palsy
mollii suit
muscle tone
balance
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2024-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Gross Motor Function Classification System (GMFCS)
timeFrame: 1 Minute
measure: Modified Tardiue Scale (MTS)
timeFrame: 5 minutes
measure: Modifiye Modified Ashworth Scale (MAS)
timeFrame: 5 Minutes
measure: NMC Tests with Seansamove Sensbalance
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.