Deformity of the Forefoot in Children With Unilateral Cerebral Palsy (Mediopied-PC)

Midfoot and backfoot deformities are well described in children with Cerebral palsy. However, data regarding forefoot deformities in Cerebral palsy remain scarce in a population were foot deformities are the most frequent musculo-skeletal deformities.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Forefoot Adductus

Detailed Description

Foot deformities are the most frequent musculo-skeletal deformities in children with Cerebral palsy. Pain starts in the foot, especially during gait in Cerebral Palsy Children (GMFCS I and II) and induce gait limitations, balance disorders, wounds, aesthetic disorders and difficulties to support shoes.

Metatarsus Adductus is the most common foot deformity in children with or without disorder, occuring on 1-2/1000 births. In 4 to 14% of the children, evolution is not favorable at 5 years. In that case, the diagnostic of Cerebral palsy have to be considered.

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • Houx
  • Concarneau, France, 29900
    • PRIGENT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Walking child with unilateral Cerebral Palsy who benefit of a 3D Motion Analysis on the motion analysis laboratory in Brest, France, between august 2012 and may 2017.

Description

Inclusion Criteria:

• Child who benefit a standardised clinical evaluation before a 3D Gait Analysis with forefoot deformity measure
• Child age less than 18 years old
• Child with left or right unilateral cerebral palsy
• Walking child ( GMFCS score I, II or III)
• In case of several 3D Gait Analysis for the child: the 3D gait analysis was chosen first before any local spasticity treatment with botulinic toxin injection or the 3D gait evaluation the more far from local spastica treatment with botulinic toxin injection was chosen in second .

Exclusion Criteria:

• Hemiplegia due to another etiology
• History of lower limb or foot surgery before the clinical evaluation
• Local spasticy treatment with botulinic toxin injection less than 3 months before the clinical evaluation
• Participation refusal

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of the forefoot deformity prevalence in plegia and non-plegia foot during gait in unilateral cerebral palsy children	we report in our population the forefoot axis measured by the angle between the heel bisector and the axis between the second and third metatarsal.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric factors (age) associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.	we report the age (years mean, standard deviation) of the patients CP	1 day
Anthropometric factors (sexe) associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.	we report the sexe of the patients (female or male)	1 day
Anthropometric factors (type of cerebral palsy)associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.	we report the plegia side of the patients cerebral palsy : right or left	1 day
functional factors associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.	we report the GMFCS score of the patients cerebral palsy : GMFCS 1, 2, 3, 4 or 5 (4-5 non ambulant 1-3 ambulant children)	1 day
biomechanical osteoarticular factors associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.	we report biomechanical osteoarticular factors : hindfoot axis, foot dorsiflexion, footprint, tibial torsion, femoral antetorsion, leg length inequality) , Spasticity of lower limb muscle (Modified Ashworth Scale and Tardieu Scale) and Motricity of lower limb muscle ( Boyd scale and MRC evaluation)	1 day
Spasticity factors associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.	we report the Spasticity of lower limb muscle (Modified Ashworth Scale and Tardieu Scale)	1 day
Motricity factors associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.	we report the motricity of lower limb muscle ( Boyd scale and MRC evaluation)	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2018
• Primary Completion (Actual): June 14, 2018
• Study Completion (Actual): June 14, 2018

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Estimate): December 22, 2022

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Forefoot Deformity
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Congenital Abnormalities; Paralysis
• Other Study ID Numbers: Mediopied-PC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No