Cerebral PalsyBB-AQMNCT03902886
Independent Walking Onset of Children With Cerebral Palsy
An observational study of Cerebral Palsy, run by University Hospital, Brest at 2 sites in 2 countries.
Trial summary
This study will focus the gait analysis, using an optoelectronic system, of children with unilateral cerebral palsy compared to typically developed children in the first 6 months of independent walking. Read more about this study
- Who is it for?
- Ages Up to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- gait analysis
- How many people
- 27 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 Sep 2018to 23 Oct 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 Up to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: 10 toddlers with unilateral CP will be compared to 10 toddlers typically developed. The populations will have maximum 6 months of walking experience.
Who may be able to join
- Maximum age of 3 years old
- Independent walking experience of maximum 6 months
- Ability to walk 5 m without falling or needing a technical assistance
- A right or left hemiplegia in a predictive clinical context of a CP at the age of 2 years
Who cannot join
- History of lower limb musculoskeletal trauma in the last 6 months
- A known skin allergy to any adhesive product
- History of lower limb musculoskeletal surgery
- History of BTX injections into the lower limbs muscles in the last 3 months
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Romania1 site
Centrul National Clinic Recuperare Copii "Dr. N. Robanescu"
Bucharest, 041408
About this study
Official title: Biomechanics and Motor Control of the First 6 Months of Independent Walking for Children With Unilateral Cerebral Palsy
This study will focus the gait analysis, using an optoelectronic system, of children with unilateral cerebral palsy compared to typically developed children in the first 6 months of independent walking.
- Conditions
- Cerebral Palsy
- Being tested
- gait analysis
- Keywords
- toddlers, gait
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait analysisDiagnostic test
gait analysis using an optoelectronic system and a surface EMG
| Study group | Role | What they receive |
|---|---|---|
| cerebral palsy infants | gait analysis Receives: Diagnostic Test: gait analysis | |
| typically developed infants | gait analysis Receives: Diagnostic Test: gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The lower limbs Global Profile Score during gait
Data will be collected from gait analysis of unilateral CP children and the Global Profile Score, characterizing the overall kinematics of the pelvis and lower limbs, during gait, will be compared those of a typical developed children group matched in walking experience. Mann Whitney U test will be used for this comparison.
Measured: All the data collection and analysis wil be done within 2 months from the start point of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start5 Sep 2018
- Primary completion23 Oct 2018
- Study completion23 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 27 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
- NCT03902886
- Sponsor's protocol ID
- BB-AQM ( 29BRC18.071)
- Acronym
- BB-AQM
- Status last verified
- Oct 2018
- First submitted
- 22 Oct 2018
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanics and Motor Control of the First 6 Months of Independent Walking for Children With Unilateral Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03902886
- Acronym / sponsor ID
- BB-AQM / BB-AQM ( 29BRC18.071)
- Conditions
- Cerebral Palsy
- Keywords
- toddlers, gait
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 23 Oct 2018 (actual)
- First posted
- 4 Apr 2019 (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.
This study will focus the gait analysis, using an optoelectronic system, of children with unilateral cerebral palsy compared to typically developed children in the first 6 months of independent walking.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cerebral palsy infants | – | Diagnostic Test: gait analysisgait analysis |
| typically developed infants | – | Diagnostic Test: gait analysisgait analysis |
Who may qualify
- Ages
- Up to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 10 toddlers with unilateral CP will be compared to 10 toddlers typically developed. The populations will have maximum 6 months of walking experience.
Key inclusion criteria (4 listed)
- Maximum age of 3 years old
- Independent walking experience of maximum 6 months
- Ability to walk 5 m without falling or needing a technical assistance
- A right or left hemiplegia in a predictive clinical context of a CP at the age of 2 years
Key exclusion criteria (4 listed)
- History of lower limb musculoskeletal trauma in the last 6 months
- A known skin allergy to any adhesive product
- History of lower limb musculoskeletal surgery
- History of BTX injections into the lower limbs muscles in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gait analysisgait analysis using an optoelectronic system and a surface EMG | Diagnostic test | cerebral palsy infants, typically developed infants |
Primary outcome
The lower limbs Global Profile Score during gait
Time frame: All the data collection and analysis wil be done within 2 months from the start point of the study.
Data will be collected from gait analysis of unilateral CP children and the Global Profile Score, characterizing the overall kinematics of the pelvis and lower limbs, during gait, will be compared those of a typical developed children group matched in walking experience. Mann Whitney U test will be used for this comparison.
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 4 Apr 2019.
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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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by University Hospital, Brest at 2 sites in 2 countries.
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 4 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 4 Apr 2019. 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, Romania. 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?
The lower limbs Global Profile Score during gait (time frame: All the data collection and analysis wil be done within 2 months from the start point of the study.). 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 4 Apr 2019.