Effectiveness of the Mollii Suit for children with cerebral palsy
Investıgatıon Of The Effectıveness Of The Mollıı Suıt In Chıldren Wıth Ambulatory Cerebral Palsy: A Double-Blınd Randomızed Controlled Study
This study is testing if the Mollii Suit can help children with spastic cerebral palsy improve their movement and reduce pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 4 Years to 18 Years |
| Sex | All |
| Sponsor | Kastamonu University Academic / other |
| Locations | 1 site (Ankara) |
| Trial ID | NCT06109129 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have shown promise with similar rehabilitation technologies, indicating potential for success with this novel approach.
Eligibility criteria
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 this trial is running
Ankara
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.