- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06532981
The Effect of AFOs on the EMG of Children With CP
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
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Laure Everaert
- Phone Number: +32472277564
- Email: laure.everaert@kuleuven.be
Study Contact Backup
- Name: Tijl Dewit
- Email: tijl.dewit@kuleuven.be
Study Locations
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgium, 3000
- Recruiting
- UZ Leuven
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Contact:
- Kaat Desloovere, prof. dr.
- Phone Number: +3216338009
- Email: kaat.desloovere@kuleuven.be
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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.
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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
Investigators
- Principal Investigator: Kaat Desloovere, Prof. dr., Department of Rehabilitation Sciences, KU Leuven, Belgium
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- s65337_s66532_EMG
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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