University Hospital, Toulouse
Toulouse, Midi-Pyrenes, 31059, France
NCT Number: NCT03468647
The object of the present project is to promote the prevention of disability by providing 1) a feedback and motivational coaching to the user, 2) relevant clinical parameters to the healthcare professionals in order to support the patient's follow-up, and 3) supporting the detection of preliminary signs of functional loss. The technical solution will contain wearable (e.g. smart insole) and ambient unobtrusive devices (e.g. weigh scale including balance analysis), and analysis and diagnosis assistance software. The devices transmit wirelessly the collected data to a remote server through a tablet. Data will then be available remotely for consultations by users (i.e. patients or physicians). The clinical evaluation will be a multi-phased design with a first living lab evaluation followed by a real life home trial to finalize the evaluation. Comprehensive assessments will be conducted to highlight the feasibility and acceptability.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
Toulouse, Midi-Pyrenes, 31059, France
Functional decline challenges the sustainability of healthcare systems. There are difficulties in implementing effective interventions to prevent disability, to promote adherence to lifestyle recommendations and to perform seamless follow-up at home. A technological solution addressing this challenge and improving individual participation would be welcome. Our aim is to evaluate an instrument for supporting physical activity and monitoring multiple parameters of frailty (a pre-disability condition) in frail elderly persons. The investigator and collaborator are therefore developing a solution to monitor key parameters of frailty during subject daily life and to promote walking. This tools are :
The primary aim is to assess the acceptability of the solution for the follow up and the motivational coaching of frail patients at home. Results from this study will also be used to elaborate the design of a further larger national multicenter randomized control trial assessing the efficiency of the solution to prevent disability.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Volunteer must walk this this connected seamless to measure different walking parameters
Other names: connected soles
This weighting machine measure weight evolution and equilibrate of volunteers
Other names: connected weighting machine
this machine measure the gripping force of volunteer
Other names: gripping force machine
Time frame: 3 months
primary outcome is based on the acceptability of the FRAGIL-IT tools for the end-user : connected soles, connected weighting machine and measure of gripping force to control autonomy loss. The acceptability of this tools will be evaluate by questionnaire as The Short Form (36) Health Survey (SF36) questionnaire
Time frame: 3 months
the life quality will be assess with SF36 questionnaire
Time frame: 3 months
functional status will be assess with Activity of Daily Living (ADL) score. The scale of ADL is between 0 to 6. 0 is worse than 6.
Time frame: 3 months
functional status will be assess with instrumental Activity of Daily Living (iADL) score. The scale of IADL is between 0 to 8. 0 is worse than 8.
Time frame: 3 months
cognitive status will be assess with Mini Mental State (MMS)
University Hospital, Toulouse
Other
FRAGIL-IT, Seamless Follow up and Support System for Frail Elderly Living at Home
Acronym: FRAGIL-IT
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