Cerebral PalsyCPABONENCT04761666
Influence of Verticalization on Bone Mineral Density and Biological Parameters of Bone Remodeling in Children With Severe Cerebral Palsy
An observational study of Cerebral Palsy and Osteoporosis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Low bone mineral density affects 77% of children with severe cerebral palsy (GMFCS IV \& V) with an increased fracture risk of 4%. One strategy supposed to improve bone mineral density is verticalisation with static devices. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Cerebral Palsy, Osteoporosis, Bone Mineral Density
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2021to 1 Jul 2023
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children whom age is between 3 and 18 years old. Children with cerebral palsy GMFCS (gross motor functionnal classification scale) IV-V.
Who may be able to join
- patients with cerebral palsy GMFCS (gross motor functional classification scale) IV-V
- age of patients 3-18 years
Who cannot join
- patients with neuro muscular disease
- patient age < 3 years old and > 18 years old
- patient with constitutionnal bone disease
- patient with growth hormone treatment
- patient with surgery < 6 months
- patient with fracture <3 months
- Refusal of the legal representative
Trial locations and contacts
1 site in 1 country.
About this study
Low bone mineral density affects 77% of children with severe cerebral palsy (GMFCS IV \& V) with an increased fracture risk of 4%. One strategy supposed to improve bone mineral density is verticalisation with static devices. Nowadays there is no time recommendation of verticalisation however high intensity verticalisation has been shown to be effective in improving bone mineral density in childrens with cerebral palsy, but difficult to apply in real life due to lack of qualified therapists, device's complexity, and severe impairment in those children. The investigators aim to compare bone mineral density and bone remodelling factors of verticalized and non verticalized childrens with severe cerebral palsy as achieved in everyday life. The investigators conduced a retrospective study comparing bone mineral density and factors who influence bone remolling in severe cerebral palsy's according to whether they are verticalized or not.
- Keywords
- Cerebral Palsy, Osteoporosis, bone mineral density, bone remodelling factors, Fracture, static verticalization device, weight bearing exersices
- Medical subject headings
- Cerebral Palsy, Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| static verticalization device | children with severe cerebral palsy (GMFCS IV \& V) with static verticalization device | |
| non verticalization device | children with severe cerebral palsy (GMFCS IV \& V) without static verticalization device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of Densitometric Z score between both groups
A Z-score compares the patient bone density to the average bone density of people your own age and gender.A Z-score is helpful in diagnosing secondary osteoporosis and is always used for children. It is most useful when the score is less than 2 standard deviations below this normal. In this setting, it is helpful to scrutinize for coexisting illnesses or treatments that may contribute to osteoporosis such as glucocorticoid therapy, hyperparathyroidism, or alcoholism.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start16 Feb 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Why it stopped: no participants enrolled
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 Centre Hospitalier Universitaire, AmiensThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761666
- Sponsor's protocol ID
- PI2021_843_0036
- Acronym
- CPABONE
- Status last verified
- Jul 2023
- First submitted
- 16 Feb 2021
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Verticalization on Bone Mineral Density and Biological Parameters of Bone Remodeling in Children With Severe Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04761666
- Acronym / sponsor ID
- CPABONE / PI2021_843_0036
- Keywords
- Cerebral Palsy, Osteoporosis, bone mineral density, bone remodelling factors, Fracture, static verticalization device, weight bearing exersices
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 21 Feb 2021 (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.
Low bone mineral density affects 77% of children with severe cerebral palsy (GMFCS IV \& V) with an increased fracture risk of 4%. One strategy supposed to improve bone mineral density is verticalisation with static devices. Nowadays there is no time recommendation of verticalisation however high intensity verticalisation has been shown to be effective in improving bone mineral density in childrens with cerebral palsy, but difficult to apply in real life due to lack of qualified therapists, device's complexity, and severe impairment in those children. The investigators aim to compare bone mineral density and bone remodelling factors of verticalized and non verticalized childrens with severe cerebral palsy as achieved in everyday life. The investigators conduced a retrospective study comparing bone mineral density and factors who influence bone remolling in severe cerebral palsy's according to whether they are verticalized or not.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| static verticalization device | – | –children with severe cerebral palsy (GMFCS IV \& V) with static verticalization device |
| non verticalization device | – | –children with severe cerebral palsy (GMFCS IV \& V) without static verticalization device |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children whom age is between 3 and 18 years old. Children with cerebral palsy GMFCS (gross motor functionnal classification scale) IV-V.
Key inclusion criteria (2 listed)
- patients with cerebral palsy GMFCS (gross motor functional classification scale) IV-V
- age of patients 3-18 years
Key exclusion criteria (7 listed)
- patients with neuro muscular disease
- patient age < 3 years old and > 18 years old
- patient with constitutionnal bone disease
- patient with growth hormone treatment
- patient with surgery < 6 months
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
Variation of Densitometric Z score between both groups
Time frame: 6 months
A Z-score compares the patient bone density to the average bone density of people your own age and gender.A Z-score is helpful in diagnosing secondary osteoporosis and is always used for children. It is most useful when the score is less than 2 standard deviations below this normal. In this setting, it is helpful to scrutinize for coexisting illnesses or treatments that may contribute to osteoporosis such as glucocorticoid therapy, hyperparathyroidism, or alcoholism.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Osteoporosis, run by Centre Hospitalier Universitaire, Amiens at 1 site 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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Variation of Densitometric Z score between both groups (time frame: 6 months). 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 20 Jul 2023.