The Effect of AFOs on the EMG of Children With CP
ConditionSpastic Cerebral Palsy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 1 trial groupGroup A: Ambulatory children with spastic CP
Trial outcomes
Primary outcomes
1
EMG-waveform amplitude & timing
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).
Time frame
One measurement of 150 minutes2
EMG co-activation
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.
Time frame
One measurement of 150 minutesSponsors and contacts
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Source ClinicalTrials.gov