Examining the effects of the Mollii Suit on balance and muscle tone in children with cerebral palsy
Examination of the Acute Effect of Mollii Suit in Children With Cerebral Palsy: A Double-Blind Randomized Controlled Study
This study is testing if wearing the Mollii Suit can help improve balance and muscle control in children with spastic cerebral palsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 4 Years to 18 Years |
| Sex | All |
| Sponsor | Kırıkkale University Academic / other |
| Locations | 1 site (Ankara) |
| Trial ID | NCT06302790 on ClinicalTrials.gov |
What this trial studies
This study investigates the acute effects of the Mollii Suit, a non-invasive neuromodulation garment, on balance and muscle tone in children diagnosed with spastic cerebral palsy. The suit utilizes electrodes to stimulate antagonist muscles, aiming to reduce spasticity and improve motor function. Participants aged 4 to 18 with a Gross Motor Classification System (GMFCS) level of 1 or 2 will be included, while those with higher GMFCS levels or recent surgical interventions will be excluded. The study is conducted at Gazi University in Ankara, Turkey.
Who should consider this trial
Good fit: Ideal candidates are children aged 4 to 18 with a diagnosis of spastic cerebral palsy and a GMFCS level of 1 or 2.
Not a fit: Patients with higher GMFCS levels (3, 4, or 5) or those who have had recent botulinum toxin injections or surgical interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance motor function and independence in daily activities for children with cerebral palsy.
How similar studies have performed: While the use of neuromodulation techniques in rehabilitation is gaining traction, the specific application of the Mollii Suit in this context is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
Ankara
- Gazi University — Ankara, Turkey (Recruiting)
Study contacts
- Study coordinator: Kübra Uğurlu
- Email: kubra.ozdamar06@gmail.com
- Phone: +905077295353
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.