Forefoot AdductusMediopied-PCNCT05662046
Deformity of the Forefoot in Children With Unilateral Cerebral Palsy
An observational study of Forefoot Adductus and Cerebral Palsy, run by University Hospital, Brest at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Forefoot Adductus, Cerebral Palsy
- How many people
- 52 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Jun 2018to 14 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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 .
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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.
- Conditions
- Forefoot Adductus, Cerebral Palsy
- Keywords
- Cerebral Palsy, Forefoot Deformity
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (7)
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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start14 Jun 2018
- Primary completion14 Jun 2018
- Study completion14 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forefoot AdductusStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662046
- Sponsor's protocol ID
- Mediopied-PC
- Acronym
- Mediopied-PC
- Status last verified
- Dec 2022
- First submitted
- 28 Mar 2019
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deformity of the Forefoot in Children With Unilateral Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05662046
- Acronym / sponsor ID
- Mediopied-PC / Mediopied-PC
- Conditions
- Forefoot Adductus, Cerebral Palsy
- Keywords
- Cerebral Palsy, Forefoot Deformity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 14 Jun 2018 (actual)
- Study completion
- 14 Jun 2018 (actual)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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 .
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Anthropometric factors (age) associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.
Time frame: 1 day
Anthropometric factors (sexe) associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.
Time frame: 1 day
Anthropometric factors (type of cerebral palsy)associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.
Time frame: 1 day
functional factors associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.
Time frame: 1 day
biomechanical osteoarticular factors associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.
Time frame: 1 day
Spasticity factors associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.
Time frame: 1 day
Motricity factors associated with forefoot deformities on plegia side in walking children with unilateral Cerebral Palsy.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Forefoot Adductus and Cerebral Palsy, run by University Hospital, Brest at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of the forefoot deformity prevalence in plegia and non-plegia foot during gait in unilateral cerebral palsy children (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.