Accidental Falls Clinical Trial
— CFCOfficial title:
Falls With Fracture : Role of Cognitive Disorders and Comparison With Bone Fragility
Verified date | March 2020 |
Source | University Hospital, Caen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether cognitive disorders are a risk factor for a fracture after a fall independently of a bone fragility.
Status | Completed |
Enrollment | 218 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years and older |
Eligibility |
Inclusion Criteria: - Affiliation to the social security system - For subjects with fracture : victim of a low-energy fracture of the upper or lower limb that was consecutive to a fall from standing height, and who has accepted to realize a DXA exam in the context of the medical follow-up - For control subjects : victim of a fall from standing height, with no fracture, matched in terms of age, sex, socio-cultural level and living space with subjects with fracture. - Written informed consent Exclusion Criteria: - Subject who is deprived of liberty, under supervision or legal guardianship - Pathology affecting balance (Parkinson's disease, after-effects of stroke, …) - Important visual impairment : age-related macular degeneration, … - Depressed state - Important consumption of alcohol (> 14 drinks per week for women / >21 for men) - Subject who is concurrently participating in another clinical study (unless prior notice of the principal investigator) - Fall has been caused by a third party (e.g. : pushing), is not from standing height (e.g. : fall from a ladder); fracture is not a low-energy one (e.g. : further a fall during running) - For subjects with fracture : - The fracture is not consecutive to a fall - The fracture is pathological, beyond osteoporosis (e.g. : bone metastases) - The last fall responsible for a fracture goes back more than 6 months - For control subjects : o The fall goes back more than 12 months - The fall has led to a medical consultation |
Country | Name | City | State |
---|---|---|---|
France | University Hospital | Caen | |
France | Dr Alain Daragon | Rouen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Analysis of a global cognitive efficiency score Analysis of bone mineral density | MMS, MoCA | on the inclusion day and two years after | |
Secondary | Age | on the inclusion day and over two years | ||
Secondary | Cognitive scores | Mainly tests of memory, attention and executive functions | on the inclusion day and over two years | |
Secondary | Fracture features | Location and severity | on the inclusion day and over two years | |
Secondary | Balance and walking parameters | Tinetti scale, TUG and dual-tasks | on the inclusion day and over two years | |
Secondary | handgrip force | using a dynamometer | on the inclusion day and over two years | |
Secondary | Daily life scales scores | Mainly IADL | on the inclusion day and over two years | |
Secondary | fear of falling | ABC-scale | on the inclusion day and over two years | |
Secondary | functional restrictions score | Lequesne score | on the inclusion day and over two years | |
Secondary | Degree of depression | MADRS | on the inclusion day and over two years | |
Secondary | biological data | 25OHD | on the inclusion day and over two years | |
Secondary | Dual-energy X-ray absorptiometry | bone mineral densitometry | on the inclusion day and two years after |
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