Fall Risk Assessment With an Innovative Device for Quantifying Gait and Static Balance in Geriatric Consultation
NCT Number: NCT06535477
Acronym: PARACHUTE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Risk of Falling in the Elderly
Interventions: DEVICE: Fall risk assessment
Sponsor: Gérond'if
Sex: ALL
Age: OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-28
Completion Date: 2025-07-28
Locations: Ambulatory Care Department, Charles Foix Hospital, Ivry-sur-Seine, IIe-de-France, 94200, France

Summary:
The main objective of this monocentric, non-randomized, prospective study was to evaluate the predictive capacity of a balance score based on spatio-temporal parameters of postural balance.

Primary Outcome Measures: Balance score, The balance score, based on a learning model incorporating spatio-temporal parameters of pressure center displacement. These parameters include amplitude along the anterior-posterior and medio-lateral axes, surface area covered, and displacement speed. The overall score is calculated on the basis of model-building data from profiles of people with and without previous falls. This score, evaluated from 0 to 100, indicates the level of balance, with a score of 99 representing optimal balance. The lower the score, the more precarious the balance, thus approximating a potential faller profile., 12 months
Secondary Outcome Measures: Evaluation of the association between each static balance indicator and fall occurrence, The following indicators will be analyzed:

* Oscillation area in mm² : Area covered by the displacement of the center of pressure, calculated by tracing the trajectory of the center of pressure and determining the minimum area that encompasses all these trajectories (contained within an ellipse of 90% confidence).
* Sway density in seconds : Duration (travel time) during the entire sequence (30s) when the center of pressure remains in the vicinity (radius less than 5 mm) of each calculated point of the center of pressure's position.
* Lateral variance in mm² : Extent of variability in the position of the center of pressure around an average position on the medial-lateral axis.
* Average oscillation speed in mm/s : Average speed of displacement of the center of pressure in all directions., 12 months
Other Outcome Measures: Measuring cognitive impairment according Mini-Mental State Examination (MMSE) score, The Mini-Mental State Examination is an unabbreviated scale title. This scale was developed as a brief screening tool to provide a quantitative evaluation of cognitive impairment and to record cognitive changes over time.

The measure yields a total score of 30. A score of 23 or less is the generally accepted cutoff point indicating the presence of cognitive impairment. Levels of impairment have also been classified as none (24-30); mild (18-23) and severe (0-17), 12 months|Assessment of physical frailty according Fried scale, This is an unabbreviated scale title.

Assessment of 5 dimensions:

* 0, 1 or 2 pathological dimensions = lack of frailty
* 3, 4 or 5 pathological dimensions = presence of frailty, 12 months|Assessment of Failty status using the Short Emergency Geriatric Assessment (SEGA), This is an unabbreviated scale title.

if SEGA score \< ou = 8 : Not very frail if it contained in the interval \[9;11\] : Rather frail if it \> ou = 12 : Very frail, 12 months|Assessment of the degree of autonomy according AGGIR score, There are six levels of GIR (GIR 1-6):

* GIR 1-2 correspond to the lowest level of autonomy
* GIR 3 and 4 correspond to average levels of loss of autonomy
* GIR 5-6 correspond to the highest level of autonomy, 12 months