NCT02316600

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 15, 2014

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

3.5 years

First QC Date

December 8, 2014

Last Update Submit

April 28, 2026

Conditions

Fragility

Keywords

elderlyRobust volunteers for the first phase;tele-monitoringself-managementPatient 65 and overPresenting a frailty syndrome for the second phase

Outcome Measures

Primary Outcomes (1)

  • 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: 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

    3 months

Study Arms (2)

Control

NO INTERVENTION

30 frail volunteers of the control group in the second phase won't be equipped with the smart insole.

Intervention

EXPERIMENTAL

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

Interventions

smart insoleDEVICE

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

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Toulouse

Toulouse, Midi-Pyrenes, 31059, France

Location

Related Publications (2)

  • Piau A, Steinmeyer Z, Charlon Y, Courbet L, Rialle V, Lepage B, Campo E, Nourhashemi F. A Smart Shoe Insole to Monitor Frail Older Adults' Walking Speed: Results of Two Evaluation Phases Completed in a Living Lab and Through a 12-Week Pilot Study. JMIR Mhealth Uhealth. 2021 Jul 5;9(7):e15641. doi: 10.2196/15641.

    PMID: 36260404RESULT

  • Piau A, Charlon Y, Campo E, Vellas B, Nourhashemi F. A Smart Insole to Promote Healthy Aging for Frail Elderly Individuals: Specifications, Design, and Preliminary Results. JMIR Rehabil Assist Technol. 2015 May 25;2(1):e5. doi: 10.2196/rehab.4084.

    PMID: 28582238RESULT

Study Officials

  • Antoine PIAU, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 15, 2014

Study Start

January 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2019

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

FR(1)