Using the Mollii Suit to help children with severe cerebral palsy
Examining the Efficacy of Mollii Suit in Children With Non-Ambule Cerebral Palsy: A Single Blind Randomized Controlled Study.
This study is testing if wearing the Mollii Suit can help children with severe cerebral palsy improve their movement and overall well-being when combined with therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 4 Years to 12 Years |
| Sex | All |
| Sponsor | Kırıkkale University Academic / other |
| Locations | 1 site (Ankara) |
| Trial ID | NCT06259864 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of the Mollii Suit in improving various aspects of health and function in children with non-ambulatory spastic cerebral palsy. Participants will be children classified at GMFCS levels 4 or 5, who will receive neurodevelopmental therapy alongside the Mollii Suit treatment for 8 weeks. The study will assess improvements in gross motor function, spasticity, postural control, and quality of life, among other factors, through evaluations conducted before and after the intervention. Participants will be randomly assigned to either the Mollii Suit group or a control group receiving standard therapy only.
Who should consider this trial
Good fit: Ideal candidates are children with spastic cerebral palsy at GMFCS levels 4 or 5 who are willing to participate.
Not a fit: Patients who have received botulinum toxin injections in the last 3 months or have had recent surgical interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life and functional abilities of children with severe cerebral palsy.
How similar studies have performed: While the use of the Mollii Suit is a novel approach, similar interventions have shown promise in improving motor function in children with cerebral palsy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * GMFCS 4 or 5 with spastic cerebral palsy children * Volunteering to participate in the study Exclusion Criteria: * Botulinum toxinA injection in the last 3 months * Surgical intervention involving the musculoskeletal system in the last 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.