Influence of Verticalization on Bone Mineral Density and Biological Parameters of Bone Remodeling in Children With Severe Cerebral Palsy

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04761666

Acronym

CPABONE

Enrollment

Registered

2021-02-21

Start date

2021-02-16

Completion date

2023-07-01

Last updated

2023-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Mineral Density, Bone Remodeling Disorder, Cerebral Palsy, Fracture, Osteoporosis

Keywords

Cerebral Palsy, Osteoporosis, bone mineral density, bone remodelling factors, Fracture, static verticalization device, weight bearing exersices

Brief 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. 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 18 Years

Healthy volunteers

Inclusion criteria

* patients with cerebral palsy GMFCS (gross motor functional classification scale) IV-V * age of patients 3-18 years

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Variation of Densitometric Z score between both groups	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.

Countries

France

Outcome results