Mollii SuitNCT06302790
Examination of the Acute Effect of Mollii Suit in Children With Cerebral Palsy
A study testing Molli Suit Apply in people with Mollii Suit and Cerebral Palsy, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Mollii Suit, Cerebral Palsy
- What is being tested?
- Molli Suit Apply
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University
Ankara
Kübra Uğurlu, +905077295353, kubra.ozdamar06@gmail.com
About this study
Official title: Examination of the Acute Effect of Mollii Suit in Children With Cerebral Palsy: A Double-Blind Randomized Controlled Study
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.
- Conditions
- Mollii Suit, Cerebral Palsy
- Being tested
- Molli Suit Apply
- Keywords
- cerebral palsy, mollii suit, muscle tone, balance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molli Suit ApplyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Molli Suit Apply |
| Control Group | No intervention | Children will be evaluated and the evaluations will be repeated 60 minutes later. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Minute
Modified Tardiue Scale (MTS)
The MTS assesses the muscle's response to stretch at given velocities.
Measured: 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.
Measured: 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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mollii SuitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Kübra Uğurlu, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302790
- Sponsor's protocol ID
- AcuteMolliiSuitEffects
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 36767576Pennati 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 34721255Flodstrom 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 33151822Nordstrom 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Acute Effect of Mollii Suit in Children With Cerebral Palsy: A Double-Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06302790
- Acronym / sponsor ID
- AcuteMolliiSuitEffects
- Conditions
- Mollii Suit, Cerebral Palsy
- Keywords
- cerebral palsy, mollii suit, muscle tone, balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Molli Suit Apply Group (Device On) | Active comparator | Other: Molli Suit ApplyEvaluations 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) | Placebo comparator | Other: Molli Suit ApplyEvaluations 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. |
| Control Group | No intervention | –Children will be evaluated and the evaluations will be repeated 60 minutes later. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molli Suit ApplyExopulse 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. | Other | Molli Suit Apply Group (Device On), Mollii Suit Placebo Group (Device Off) |
Primary outcome
Gross Motor Function Classification System (GMFCS)
Time frame: 1 Minute
Gross Motor Function Classification System (GMFCS) developed by R. Palisano will be used in the classification of motor function.
Modified Tardiue Scale (MTS)
Time frame: 5 minutes
The MTS assesses the muscle's response to stretch at given velocities.
Modifiye Modified Ashworth Scale (MAS)
Time frame: 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.
NMC Tests with Seansamove Sensbalance
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Results publication: PubMed 36767576Rubio-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.
- Results publication: PubMed 34721255Pennati 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.
- Results publication: PubMed 33151822Flodstrom 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.
- Results publication: PubMed 30945989Nordstrom 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Molli Suit Apply in people with Mollii Suit and Cerebral Palsy, run by Kırıkkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kübra Uğurlu (+905077295353, kubra.ozdamar06@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Classification System (GMFCS) (time frame: 1 Minute). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06302790, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.