Deformity of the Forefoot in Children With Unilateral Cerebral Palsy

Cerebral Palsy Clinical Trial

— Mediopied-PC  

Official title:

Deformity of the Forefoot in Children With Unilateral Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05662046
• Other study ID #: Mediopied-PC
• Status: Completed
• Start date: June 14, 2018
• Est. completion date: June 14, 2018

Study information

• Verified date: December 2022
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 14, 2018
• Est. primary completion date: June 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Congenital Abnormalities
• Paralysis

Locations

Country	Name	City	State
France	Houx	Brest
France	PRIGENT	Concarneau

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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