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

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ClinicalTrials.gov Identifier: NCT02316600
Recruitment Status : Recruiting
First Posted : December 15, 2014
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief 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.

Condition or disease Intervention/treatment Phase
Fragility Device: smart insole Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mobility Assessment & Follow-up in Frail Elderly: Clinic-technical Validation of a Smart Insole in Real Life
Study Start Date : January 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
No Intervention: Control
30 frail volunteers of the control group in the second phase won't be equipped with the smart insole.
Experimental: Intervention
30 frail volunteers of the intervention group in the second phase will be equipped with the smart insole for 3 months, to encourage the frail elderly person's physical activity and to monitor key parameters of frailty
Device: smart insole
smart insole to encourage the frail elderly person's physical activity and to monitor key parameters of frailty




Primary Outcome Measures :
  1. acceptability of the solution [ Time Frame: 3 months ]

    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:

    1. 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.
    2. Spontaneous use of data consultation interface (frequency)

    Qualitative indicators:

    Semi-structures interview conducted by the laboratory AGIM of the University Joseph Fournié




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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316600


Contacts
Contact: Antoine PIAU 05 61 32 30 10 ext 33 piau.a@chu-toulosue.fr
Contact: Fati NOURHASHEMI 05 61 77 64 69 ext 33 nourhashemi.f@chu-toulouse.fr

Locations
France
University Hospital, Toulouse Recruiting
Toulouse, Midi-Pyrenes, France, 31059
Contact: Antoine PIAU, MD    0561323010 ext 33    piau.a@chu-toulouse.fr   
Contact: Fati NOURHASHEMI, MD    0561776469 ext 33    nourhashemi.f@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Antoine PIAU, MD University Hospital, Toulouse

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02316600     History of Changes
Other Study ID Numbers: 13 6991 17
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by University Hospital, Toulouse:
elderly
Robust volunteers for the first phase;
tele-monitoring
self-management
Patient 65 and over
Presenting a frailty syndrome for the second phase