Investigating how ankle-foot orthoses affect muscle activity in children with cerebral palsy
The Effect of the Ankle-foot Orthosis on Muscle Activity in the Lower Limbs in Children With Cerebral Palsy
This study is testing how ankle-foot braces can change muscle activity in children with cerebral palsy while they walk to help improve their mobility.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06532981 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on children with spastic cerebral palsy (CP) to assess the impact of ankle-foot orthoses (AFOs) on muscle activity during walking. It aims to analyze the amplitude, timing, and co-activation of lower limb muscles, particularly the medial gastrocnemius and tibialis anterior. Participants will undergo a standard clinical examination followed by a three-dimensional gait analysis to gather data on muscle performance. The findings could provide insights into optimizing AFO prescriptions for improved mobility in children with CP.
Who should consider this trial
Good fit: Ideal candidates include children aged 6 to 17 years with spastic CP who are classified as GMFCS level I-III and have been prescribed AFOs.
Not a fit: Patients with severe contractures, cognitive or visual impairments, or those who have had recent surgeries on their legs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of AFOs' effects on muscle activity, leading to better rehabilitation strategies for children with cerebral palsy.
How similar studies have performed: Previous studies have shown varying effects of AFOs on gait mechanics, but this specific focus on muscle activity remains less explored, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Gross Motor Function Classification System (GMFCS) level I - III * CP (bilateral \& unilateral) * Age: 6 - 17 years * Prescribed AFO by the medical team (as part of the standard care) Exclusion criteria: * Severe contractures or spasticity, which makes it impossible to wear a conventional AFO * Cognitive or visual impairment that hinder them to understand instructions * Previous surgery on bones and/or muscles of the legs in the last 12 months prior to assessment * Presence of ataxia or dystonia
Where this trial is running
Leuven, Vlaams-Brabant
- UZ Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Kaat Desloovere, Prof. dr. — Department of Rehabilitation Sciences, KU Leuven, Belgium
- Study coordinator: Laure Everaert
- Email: laure.everaert@kuleuven.be
- Phone: +32472277564
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.