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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06302790
Enrollment
30
Registered
2024-03-12
Start date
2024-03-01
Completion date
2025-05-01
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Mollii Suit

Keywords

cerebral palsy, mollii suit, muscle tone, balance

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.

Interventions

OTHERMolli 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.

Sponsors

Gazi University
CollaboratorOTHER
Kırıkkale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

The statistician in the study and the physiotherapist performing the evaluation will be blinded.

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Gross Motor Function Classification System (GMFCS)1 MinuteGross Motor Function Classification System (GMFCS) developed by R. Palisano will be used in the classification of motor function.
Modified Tardiue Scale (MTS)5 minutesThe MTS assesses the muscle's response to stretch at given velocities.
Modifiye Modified Ashworth Scale (MAS)5 MinutesThe 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.
NMC Tests with Seansamove Sensbalance5 minutesNMC 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactKübra Uğurlu
kubra.ozdamar06@gmail.com+905077295353
Backup ContactBülent Elbasan
bulentelbasan@gmail.com+905324672923

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026