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

NCT ID: NCT04761666

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-16
• Study Completion Date: 2023-07-01

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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

static verticalization device

children with severe cerebral palsy (GMFCS IV \& V) with static verticalization device

No interventions assigned to this group

non verticalization device

children with severe cerebral palsy (GMFCS IV \& V) without static verticalization device

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens

Amiens, , France

Countries

France

Other Identifiers

PI2021_843_0036

Identifier Type: -

Identifier Source: org_study_id