The Effect of AFOs on the EMG of Children With CP

February 9, 2026 updated by: Kaat Desloovere, Universitaire Ziekenhuizen KU Leuven

The Effect of the Ankle-foot Orthosis on Muscle Activity in the Lower Limbs in Children With Cerebral Palsy

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.

Study Overview

Status

Recruiting

Detailed Description

With a prevalence of two to three per 1000 live births, Cerebral Palsy (CP) is the most common motor disability of childhood. Improving disturbed gait in ambulatory children with CP is an important treatment goal because it is associated with functional independence and participation of children in the society. It is a common practice to prescribe ankle-foot orthoses (AFO) for ambulatory children to improve their gait, prevent secondary deformities, provide an improved base of support, and compensate for muscle weakness.

Previous research highlighted that there is a direct effect on the muscle activity of the distal muscles and an indirect effect on the proximal muscles. However, the impact of the AFO on the muscle activity of the plantar and dorsiflexors is clinically relevant since reduced muscle activity may lead to muscle atrophy and altered motor control. Therefore, more research is needed on the effect of AFOs on the medial gastrocnemius and the tibialis anterior, in both unilaterally and bilaterally involved children. Moreover, the impact of the AFO on the muscle activity of the quadriceps, apart from the hamstrings, needs to be further explored as well.

The purpose of the current study is to investigate the effect of the AFO on muscle activity in the distal and proximal leg muscles of children with CP while walking.

On the measurement day, subjects will first receive a standard clinical examination preceding the clinical overground three-dimensional gait analysis (3DGA) that is planned as a routine clinical follow-up at the CMAL (clinical motion analysis laboratory), extended with an additional 3DGA on the treadmill. The treadmill gait laboratory and overground gait laboratory are across the hall from each other, which makes it possible for the subject to walk from one to the other gait laboratory in just a minute. During the 3DGA, kinematic, kinetic and EMG-data will be collected.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Ambulant children with cerebral palsy between 6 and 17 years old with a consistent gait pattern. They have prescribed ankle-foot orthoses by the medical team as part of the standard care.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Ambulatory children with spastic CP
Ambulant children with cerebral palsy between 6 and 17 years old with a consistent gait pattern. They have prescribed ankle-foot orthoses by the medical team as part of the standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EMG-waveform amplitude & timing
Time Frame: 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).
One measurement of 150 minutes
EMG co-activation
Time Frame: 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.
One measurement of 150 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kaat Desloovere, Prof. dr., Department of Rehabilitation Sciences, KU Leuven, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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