Clinical Trial: 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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title:

Brief Summary:

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 .


Detailed Summary:
Sponsor: Assistance Publique Hopitaux De Marseille

Current Primary Outcome: foot morphology variation [ Time Frame: 3 months ]

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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • age [ Time Frame: 3 months ]
    year
  • sex [ Time Frame: 3 months ]
    female or male
  • weight [ Time Frame: 3 months ]
  • Body Mass Index (BMI) [ Time Frame: 3 months ]
  • Percentage of premature onset of muscle activity (EMG) [ Time Frame: 3 months ]
  • Radiological data [ Time Frame: 3 months ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique Hopitaux De Marseille

Dates:
Date Received: July 28, 2016
Date Started: January 2016
Date Completion: November 2016
Last Updated: August 1, 2016
Last Verified: July 2016