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Completed

NCT Number: NCT05662046

Deformity of the Forefoot in Children With Unilateral Cerebral Palsy

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.

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Houx, Brest, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Measure of the forefoot deformity prevalence in plegia and non-plegia foot during gait in unilateral cerebral palsy children

    Time frame: 1 day

    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.

Secondary outcomes

  1. Anthropometric factors (age) associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.

    Time frame: 1 day

    we report the age (years mean, standard deviation) of the patients CP

  2. Anthropometric factors (sexe) associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.

    Time frame: 1 day

    we report the sexe of the patients (female or male)

  3. Anthropometric factors (type of cerebral palsy)associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.

    Time frame: 1 day

    we report the plegia side of the patients cerebral palsy : right or left

  4. functional factors associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.

    Time frame: 1 day

    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)

  5. biomechanical osteoarticular factors associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.

    Time frame: 1 day

    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)

  6. Spasticity factors associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.

    Time frame: 1 day

    we report the Spasticity of lower limb muscle (Modified Ashworth Scale and Tardieu Scale)

  7. Motricity factors associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.

    Time frame: 1 day

    we report the motricity of lower limb muscle ( Boyd scale and MRC evaluation)

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: Mediopied-PC

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 22, 2022
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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