The Effect of AFOs on the EMG of Children With CP

NCT06532981 | Recruiting

• 1 other identifier: s65337_s66532_EMG
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spastic Cerebral Palsy

Keywords

Cerebral Palsy; Rehabilitation; Gait analysis; Variability

Outcome Measures

Primary Outcomes (2)

• 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).

  One measurement of 150 minutes

• 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.

  One measurement of 150 minutes

Study Arms (1)

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.

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Kaat Desloovere, Prof. dr.

  Department of Rehabilitation Sciences, KU Leuven, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laure Everaert

CONTACT

+32472277564; laure.everaert@kuleuven.be

Tijl Dewit

CONTACT

tijl.dewit@kuleuven.be

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: August 1, 2024
• Study Start: January 6, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 12, 2026

Record last verified: 2025-10

Locations

BE (1)