Fall, Fall Patients, Osteoporosis
Conditions
Keywords
FeetMe, Insoles, Fall, Osteoporosis
Brief summary
The objective of this study is to determine which gait parameters measured at home using e FeetMe® Insoles are associated with a risk for falls in a patient population suffering from osteoporosis and a higher with high risk of fractures and falls. Each patient will be asked to go to 3 visits at the Cochin hospital, and to wear the soles after each of these visits during 3 days, at home, to record the data, so that it reflects walking patterns of the patient in his/her daily life and activities. At the eachvisit, clinical tests to assess fall risk will be performed (Timed Up and Go test, one foot stance, Short Physical Performance Battery and 6 minutes walking test ). The patients will be supplied with a pair of FeetMe® Monitor Insoles, return home and walking parameters will be recorded for 3 to 10 consecutive days.
Interventions
DEVICEFeetMe® Monitor
Each patient will be asked to go to 3 visits at the Cochin hospital, and to wear the soles after each of these visits during 3 days, at home, to record the data, so that it reflects walking patterns of the patient in his/her daily life and activities. At each visit, clinical tests to assess fall risk will be performed (Timed Up and Go test, one foot stance, Short Physical Performance Battery and 6 minutes walking test ). The patients will be supplied with a pair of FeetMe® Monitor insoles, return home and walking parameters will be recorded for 3 to 10 consecutive days.
Sponsors
FeetMe
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male and female subjects aged 60 years and above * with a high fracture and fall risk defined by osteoporosis (low-trauma fracture within the last 5 years and/or osteoporotic bone density) * a fall within the last year, who own a smartphone.
Exclusion criteria
* cognitive deficit or concomitant disorder limiting communication or participation in the study * simultaneous participation in another study * deprivation of liberty due to a legal or administrative decision * patients receiving psychiatric care * adults beyond the age of majority under legal protection measures or unable to express their consent * patients admitted to a health or social establishment for reasons other than research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess how a walking speed decrease at baseline during a 6MWT as measured by the connected Insoles, connected insoles devices, has an effect on risk of fall in subjects with osteoporosis. | at baseline | Assess walking speed decrease during 6MWT at baseline |
Countries
France
Outcome results
None listed