Effectiveness of the Mollii Suit for children with cerebral palsy
Official title: Investıgatıon Of The Effectıveness Of The Mollıı Suıt In Chıldren Wıth Ambulatory Cerebral Palsy: A Double-Blınd Randomızed Controlled Study
Run by Kastamonu University · NCT06109129 · Data updated 2026-11-12
This study is testing if the Mollii Suit can help children with spastic cerebral palsy improve their movement and reduce pain.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 4 Years to 18 Years |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | Kastamonu University Academic / other |
| Locations | 1 site (Ankara) |
| Status | Recruiting |
| Started | November 5, 2023 |
| Main results expected | November 5, 2025 |
| Study ends | November 5, 2025 |
| Registry record updated | July 11, 2025 |
| Trial ID | NCT06109129 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 4 to 18 with a diagnosis of spastic cerebral palsy who can express pain and discomfort.
✕Probably not a fit
Patients classified as level 4-5 on the Gross Motor Classification System or those who have had recent botulinum toxin applications or surgical interventions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of the EXOPULSE Mollii Suit, a non-invasive neuromodulation garment designed to improve motor function in children with spastic cerebral palsy. The suit uses electrodes to stimulate the antagonist muscles of spastic areas, aiming to reduce spasticity and pain. Participants will be assessed on various outcomes including gross and fine motor function, balance, and quality of life. The study targets children aged 4 to 18 who have a specific diagnosis of spastic CP and are classified between levels 1-3 on the Gross Motor Classification System.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance motor function and quality of life for children with cerebral palsy.
How similar studies have gone: Previous studies have shown promise with similar rehabilitation technologies, indicating potential for success with this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Being a voluntary participant in the study, * Having a diagnosis of spastic CP, * Being between 1-3 on the Gross Motor Classification System (GMFCS), * Being between the ages of 4 and 18, * Being able to express pain and discomfort Exclusion Criteria: * Being between 4-5 on Gross Motor Classification System (GMFCS) * Having Botolunim Toxin A application before 3 months * Having a surgical intervention before 6 months * Having a shunt or an invasive medical pump (baclofen, insulin, etc.)
Where it's running
-
Gazi University
Ankara, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Hidayet Cuha, PHD Candidate
- Email: hcuha@kastamonu.edu.tr
- Phone: +90 534 646 01 06
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study looks at whether individualized multisite upper limb surgery helps improve hand function in kids with hemiplegic cerebral palsy, using each child as their own control before and after surgery.
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This study tests whether walking with non-invasive spinal stimulation reduces leg muscle tightness and improves walking in children and young adults with cerebral palsy.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.