Mobility Assessment & Follow-up in Frail Elderly: Clinic-technical Validation of a Smart Insole in Real Life

Fragility Clinical Trial

— RESPECT  

Official title:

Mobility Assessment & Follow-up in Frail Elderly: Clinic-technical Validation of a Smart Insole in Real Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316600
• Other study ID #: 13 6991 17
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: July 2019

Study information

• Verified date: July 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators aim is to evaluate an instrument for supporting physical activity and monitors multiple parameters of frailty (a pre-disability condition) in frail elderly persons. The investigators are therefore developing a smart shoe insole to monitor key parameters of frailty during subject daily life and to promote walking. Our 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 efficacy of the solution to prevent disability.

Description:

The object of the present project is to promote the prevention of disability by providing 1) a feed-back 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 device consists of a smart, removable insole. It measures dynamic characteristics of gait (e.g., speed, variability, distance) as well as body weight modifications with minimal invasiveness. The insole transmits wireless the collected data to a storage server through a touchpad. Data will then be available for at distance consultations by users (i.e., patients or physicians). The investigators will conduct a wide range of evaluations of the device (technical, clinical, social, ergonomic, and economic), which will allow the optimization of the prototype. The evaluation of the prototypes will preliminary takes place at the Blagnac smart house. 10 healthy volunteers will test the device. The second evaluation phase will involve 60 frail community-dwelling subjects, with 30 of them which will use the smart insoles for 3 months. Comprehensive assessments will be conducted to highlight the feasibility, acceptability, interoperability, integration in healthcare network, and clinical relevance of the technological device in comparison to usual care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patient aged 65 or more, living at home;

• Presenting a frailty syndrome for the second phase, and robust volunteers for the first phase;

• Informed and written consent by the patient or the legal representative or the reliable person when appropriate.

Exclusion Criteria:

• No access to ADSL;

• Patient's life expectancy less than 12 months;

• Patient presenting disability with an Activity of Daily Living score < 4/6 and/or a Mini Mental State <24/30;

• Non agreement of study participation of patients or legal representative or the reliable person when appropriate.

Related Conditions & MeSH terms

• Fragility

Intervention

Device:
• smart insole
smart insole to encourage the frail elderly person's physical activity and to monitor key parameters of frailty

Locations

Country	Name	City	State
France	University Hospital, Toulouse	Toulouse	Midi-Pyrenes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acceptability of the solution	based on the acceptability of the solution for the user which will be assessed in the intervention group by: quantitative and qualitative indicators; Quantitative indicators: Proportion of hours which the subject is awake and actually wears the smart shoe insole. This information will be collected by semi-structured interview and records actimetry of the solution.; Spontaneous use of data consultation interface (frequency); Qualitative indicators: Semi-structures interview conducted by the laboratory AGIM of the University Joseph Fournié	3 months