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

Withdrawn

• Conditions: Bone Mineral Density; Bone Remodeling Disorder; Cerebral Palsy; Osteoporosis; Fracture

• Registration Number: NCT04761666
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-16
• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-21
• Status Verified: 2023-07
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France