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RecruitingNCT06302790Updated Mar 12, 2024

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

An interventional study of Molli Suit Apply in Mollii Suit and Cerebral Palsy, sponsored by Kırıkkale University. Recruiting at 1 site in Turkey. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by Kırıkkale University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
4 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mollii Suit
  • Cerebral Palsy

Keywords

  • cerebral palsy
  • mollii suit
  • muscle tone
  • balance
03

In context

Paralysis

750 studies on the registry are indexed under Paralysis; 133 are open to participants now.

This study's planned enrollment of 30 is close to the median of 30 across 537 interventional studies indexed under Paralysis.

Browse Paralysis studies →

Lead sponsor

Kırıkkale University is the lead sponsor of 112 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 18 Years
Sexes eligible
All
Accepts 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

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.)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • 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

  • 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

  • No intervention
    Control Group

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

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 Minute

  2. Modified Tardiue Scale (MTS)

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

    Time frame: 5 minutes

  3. 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.

    Time frame: 5 Minutes

  4. 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.

    Time frame: 5 minutes

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 36767576 ↗
  • 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. PubMed 34721255 ↗
  • 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. PubMed 33151822 ↗
  • 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. PubMed 30945989 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06302790
Lead sponsor
Kırıkkale University
Collaborators
Gazi University
Responsible party
Kübra Uğurlu (research assistant, Kırıkkale University) — Principal investigator
First posted
Mar 12, 2024
Start date
Mar 1, 2024
Primary completion
Mar 1, 2025 (estimated)
Completion
May 1, 2025 (estimated)
Last update
Mar 12, 2024

Study contacts

Kübra Uğurlu
Contact
kubra.ozdamar06@gmail.com
+905077295353
Bülent Elbasan
Contact
bulentelbasan@gmail.com
+905324672923

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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