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Search / Trial NCT06532981

The Effect of AFOs on the EMG of Children With CP

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Jul 29, 2024

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Cerebral Palsy Rehabilitation Gait Analysis Variability

ClinConnect Summary

This clinical trial is studying how wearing ankle-foot orthoses (AFOs) affects muscle activity in children with spastic cerebral palsy (CP). Children with CP often have difficulty walking due to changes in how their muscles work. AFOs are devices that can help improve their walking patterns, but we don’t fully understand how these devices influence the muscles in their legs. The researchers want to see how AFOs impact the strength and timing of muscle movements, as well as how different muscles work together when children walk.

To participate in this study, children aged 6 to 17 with a diagnosis of CP, who have been prescribed AFOs as part of their treatment, may be eligible. They must be classified as level I to III on the Gross Motor Function Classification System, which helps to understand their mobility abilities. However, children with certain conditions, like severe muscle tightness or those who have had recent leg surgery, may not qualify. Participants will have the opportunity to contribute to important research that could help improve treatments for children with CP, and they can expect a supportive environment as they take part in the study.

Gender

ALL

Eligibility 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

About Universitaire Ziekenhuizen Ku Leuven

Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.

Locations

Leuven, Vlaams Brabant, Belgium

Patients applied

0 patients applied

Trial Officials

Kaat Desloovere, Prof. dr.

Principal Investigator

Department of Rehabilitation Sciences, KU Leuven, Belgium

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported