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

NCT04761666 | Withdrawn

• 1 other identifier: PI2021_843_0036
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (2)

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

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children whom age is between 3 and 18 years old. Children with cerebral palsy GMFCS (gross motor functionnal classification scale) IV-V.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Cerebral Palsy; Osteoporosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: February 16, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)