PerLE (Peroneus Longus Evaluation): A Study Evaluating the Efficacy of Injection of Dysport in Peroneus Longus in Equinus Foot Deformity in Children With Cerebral Palsy (PerLE)

A recent publication (Boulay et al. 2012) highlighted the role of the peroneus longus (PL) muscle in equinus foot deformity in children with hemiplegia. BoNT (Dysport) injections into this muscle have not yet been described in the literature. Based on the results of a previous study, the hypothesis is: this muscle may thus constitute a new therapeutic target for botulinum toxin injections in the early management of spastic equinus in children aged 2 years or older, before the onset of fixed neuro-orthopedic deformity and the midfoot break.

The aim of this retrospective study is to describe in intramuscular BoNT (Dysport) injections into PL based on the results obtained in a cohort of children (approximately 30 subjects) with cerebral palsy (hemiplegia or diplegia) and which have been treated in the service since 2007 until July 2012.

The investigators results are based on clinical, radiological and video evaluations. For this study, data will be collected in medical folder of each children belonging to this cohort.

All children (approximately 30 subjects) with cerebral palsy (hemiplegia or diplegia) which have been treated by BoNT (Dysport) intramuscular injections into PL in the service between 2007 and July 2012 will be screened. Subjects will be selected according to the following defined inclusion and exclusion criteria.

Data will be collected retrospectively (using a specific case report form designed for the study) in medical folder of each included subject for all visit of follow-up after BoNT (Dysport) injection into PL (since the first BoNT (Dysport) injection up to 2012). Then, data will be entered in a database. After that, they will be analysed .

Study Overview

• Status: Unknown
• Conditions: Equinus Foot Deformity in Children With Cerebral Palsy

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Hopital de la Timone
    • Contact: Christophe BOULAY; Phone Number: 0491384216; Email: christophe.boulay@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

children with cerebral palsy (hemiplegia or diplegia) which have been treated by BoNT (Dysport) intramuscular injections into PL in the service between 2007 and July 2012 .

Description

Inclusion Criteria:

• Children between 2 and 6 years of age with cerebral palsy treated by intramuscular injection of BoNT (Dysport) into the PL (only) between 2007 and 2012.
• At least one BoNT (Dysport) injection performed into PL only
• Hemiplegic or diplegic subjects
• Dynamic equinus with hindfoot valgus with a documented premature onset activity of the peroneus longus which occurred earlier than the onset of Gastrocnemius Medialis (GM) activity, during terminal SW (i.e. EMG background data available).
• Evaluation based on Gross Motor Function Classification System (GMFCS ≤ 2) performed for children aged to 6-12 years (i.e available in the subject's medical folder).
• Feet Xrays data available before the first injection of BoNT (Dysport) and after for each subject
• Pre- and post-BoNT (Dysport) injection radiological data available in the subjects's medical folder

Exclusion Criteria:

• Equinus deformity due to a triceps surae contracture and a limb length discrepancy over 1 cm.
• Other muscle than PL injected with BoNT (Dysport) during the evaluation period (between the pre- ant post-BoNT (Dysport) radiological evaluation)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
foot morphology variation	radiological foot parameters including measured forefoot pronation (metatarsal stacking angle), midfoot planus (lateral talo-first metatarsal or Meary angle) and equinovalgus hind foot (incidence of postero-anterior ankle, calcaneal pitch and talocalcaneal angles)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
age	year	3 months
sex	female or male	3 months
weight		3 months
Body Mass Index (BMI)		3 months
Percentage of premature onset of muscle activity (EMG)		3 months
Radiological data		3 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ANTICIPATED): August 1, 2016
• Study Completion (ANTICIPATED): November 1, 2016

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (ESTIMATE): August 4, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): August 4, 2016
• Last Update Submitted That Met QC Criteria: August 1, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Lower Extremity Deformities, Congenital; Cerebral Palsy; Congenital Abnormalities; Foot Deformities; Foot Deformities, Congenital
• Other Study ID Numbers: 2014-52