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Clinical Trials in Belgium / NCT06532981
Recruiting Observational

The Effect of AFOs on the EMG of Children With CP

NCT06532981 · tracked via the Priya Life Science Belgium tracker
Sponsor
Universitaire Ziekenhuizen KU Leuven
Phase
Observational
Started
2023-01-06
Last updated
2026-02-12

Condition(s) studied

Spastic Cerebral Palsy

Study summary

Children with cerebral palsy (CP) have altered gait patterns as a result of primary and secondary symptoms. Ankle-foot orthoses (AFOs) are frequently used to improve their gait. Despite evidence of AFO-effects on gait kinetics and -kinematics, the effects on muscle activity remain unclear.

This study will investigate the effect of AFOs on the amplitude and timing, as well as the co-activation of lower limb muscle activity in children with spastic CP.

Eligibility

Sex
ALL
Min age
6 Years
Max age
17 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • EMG-waveform amplitude & timing — One measurement of 150 minutes
    The averaged time-normalized continuous EMG-waveforms for each walking condition (i.e., barefoot, AFO, overground and on the treadmill) the following muscles: the quadriceps (m. rectus femoris, m. vastus lateralis), the hamstrings (m. semitendinosus, m. biceps femoris) and the shank (m. gastrocnemius medialis, m. tibialis anterior).
  • EMG co-activation — One measurement of 150 minutes
    The co-activation was calculated by defining the synchronised activations of the agonist and antagonist muscles. To quantify the co-activation, the on- and off-timing of the muscle activity needed to be defined for the rectus femoris, the medial hamstrings, the gastrocnemius and the tibialis anterior.

Trial sites (1)

FacilityCityRegionStatus
UZ Leuven Leuven Vlaams-Brabant Recruiting

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Other trials for the same condition

Evaluation of Macroscopic Muscle Growth in Infants and Young Children With Spastic Cerebral Palsy Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06532981 on ClinicalTrials.gov ↗ ← All trials in Belgium