NCT05662046

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2019

Completed
3.7 years until next milestone

First Posted

Study publicly available on registry

December 22, 2022

Completed
Last Updated

December 22, 2022

Status Verified

December 1, 2022

Enrollment Period

Same day

First QC Date

March 28, 2019

Last Update Submit

December 14, 2022

Conditions

Keywords

Cerebral PalsyForefoot Deformity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

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

    1 day

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

    1 day

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

    1 day

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

    1 day

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

    1 day

  • +2 more secondary outcomes

Eligibility Criteria

Age2 Years - 18 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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 .

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Houx

Brest, 29609, France

Location

PRIGENT

Concarneau, 29900, France

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2019

First Posted

December 22, 2022

Study Start

June 14, 2018

Primary Completion

June 14, 2018

Study Completion

June 14, 2018

Last Updated

December 22, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning three years and ending fifteen years following the final study report completion
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.

Locations