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

NCT ID: NCT02316600

Last Updated: 2019-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2019-07-31

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.

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.

Conditions

Fragility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

smart insole

Intervention Type: DEVICE

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

Interventions

smart insole

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoine PIAU, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital, Toulouse

Toulouse, Midi-Pyrenes, France

Countries

France

References

Abellan van Kan G, Rolland Y, Bergman H, Morley JE, Kritchevsky SB, Vellas B. The I.A.N.A Task Force on frailty assessment of older people in clinical practice. J Nutr Health Aging. 2008 Jan;12(1):29-37. doi: 10.1007/BF02982161.

Reference Type: BACKGROUND

PMID: 18165842 (View on PubMed)

Ahmed N, Mandel R, Fain MJ. Frailty: an emerging geriatric syndrome. Am J Med. 2007 Sep;120(9):748-53. doi: 10.1016/j.amjmed.2006.10.018.

Reference Type: BACKGROUND

PMID: 17765039 (View on PubMed)

Barlow J, Singh D, Bayer S, Curry R. A systematic review of the benefits of home telecare for frail elderly people and those with long-term conditions. J Telemed Telecare. 2007;13(4):172-9. doi: 10.1258/135763307780908058.

Reference Type: BACKGROUND

PMID: 17565772 (View on PubMed)

Binder EF, Schechtman KB, Ehsani AA, Steger-May K, Brown M, Sinacore DR, Yarasheski KE, Holloszy JO. Effects of exercise training on frailty in community-dwelling older adults: results of a randomized, controlled trial. J Am Geriatr Soc. 2002 Dec;50(12):1921-8. doi: 10.1046/j.1532-5415.2002.50601.x.

Reference Type: BACKGROUND

PMID: 12473001 (View on PubMed)

Boyd CM, Xue QL, Simpson CF, Guralnik JM, Fried LP. Frailty, hospitalization, and progression of disability in a cohort of disabled older women. Am J Med. 2005 Nov;118(11):1225-31. doi: 10.1016/j.amjmed.2005.01.062.

Reference Type: BACKGROUND

PMID: 16271906 (View on PubMed)

Brown M, Sinacore DR, Ehsani AA, Binder EF, Holloszy JO, Kohrt WM. Low-intensity exercise as a modifier of physical frailty in older adults. Arch Phys Med Rehabil. 2000 Jul;81(7):960-5. doi: 10.1053/apmr.2000.4425.

Reference Type: BACKGROUND

PMID: 10896013 (View on PubMed)

Cesari M, Kritchevsky SB, Penninx BW, Nicklas BJ, Simonsick EM, Newman AB, Tylavsky FA, Brach JS, Satterfield S, Bauer DC, Visser M, Rubin SM, Harris TB, Pahor M. Prognostic value of usual gait speed in well-functioning older people--results from the Health, Aging and Body Composition Study. J Am Geriatr Soc. 2005 Oct;53(10):1675-80. doi: 10.1111/j.1532-5415.2005.53501.x.

Reference Type: BACKGROUND

PMID: 16181165 (View on PubMed)

Cesari M, Onder G, Russo A, Zamboni V, Barillaro C, Ferrucci L, Pahor M, Bernabei R, Landi F. Comorbidity and physical function: results from the aging and longevity study in the Sirente geographic area (ilSIRENTE study). Gerontology. 2006;52(1):24-32. doi: 10.1159/000089822.

Reference Type: BACKGROUND

PMID: 16439821 (View on PubMed)

Cesari M, Kritchevsky SB, Newman AB, Simonsick EM, Harris TB, Penninx BW, Brach JS, Tylavsky FA, Satterfield S, Bauer DC, Rubin SM, Visser M, Pahor M; Health, Aging and Body Composition Study. Added value of physical performance measures in predicting adverse health-related events: results from the Health, Aging And Body Composition Study. J Am Geriatr Soc. 2009 Feb;57(2):251-9. doi: 10.1111/j.1532-5415.2008.02126.x.

Reference Type: BACKGROUND

PMID: 19207142 (View on PubMed)

Chan M, Campo E, Esteve D, Fourniols JY. Smart homes - current features and future perspectives. Maturitas. 2009 Oct 20;64(2):90-7. doi: 10.1016/j.maturitas.2009.07.014. Epub 2009 Sep 2.

Reference Type: BACKGROUND

PMID: 19729255 (View on PubMed)

Daniels R, van Rossum E, de Witte L, Kempen GI, van den Heuvel W. Interventions to prevent disability in frail community-dwelling elderly: a systematic review. BMC Health Serv Res. 2008 Dec 30;8:278. doi: 10.1186/1472-6963-8-278.

Reference Type: BACKGROUND

PMID: 19115992 (View on PubMed)

Dolansky MA, Moore SM. Effects of cardiac rehabilitation on the recovery outcomes of older adults after coronary artery bypass surgery. J Cardiopulm Rehabil. 2004 Jul-Aug;24(4):236-44. doi: 10.1097/00008483-200407000-00005.

Reference Type: BACKGROUND

PMID: 15286528 (View on PubMed)

Ensrud KE, Ewing SK, Taylor BC, Fink HA, Stone KL, Cauley JA, Tracy JK, Hochberg MC, Rodondi N, Cawthon PM; Study of Osteoporotic Fractures Research Group. Frailty and risk of falls, fracture, and mortality in older women: the study of osteoporotic fractures. J Gerontol A Biol Sci Med Sci. 2007 Jul;62(7):744-51. doi: 10.1093/gerona/62.7.744.

Reference Type: BACKGROUND

PMID: 17634322 (View on PubMed)

Ettinger WH Jr, Burns R, Messier SP, Applegate W, Rejeski WJ, Morgan T, Shumaker S, Berry MJ, O'Toole M, Monu J, Craven T. A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis. The Fitness Arthritis and Seniors Trial (FAST). JAMA. 1997 Jan 1;277(1):25-31.

Reference Type: BACKGROUND

PMID: 8980206 (View on PubMed)

Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

Reference Type: BACKGROUND

PMID: 11253156 (View on PubMed)

Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, and comorbidity: implications for improved targeting and care. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):255-63. doi: 10.1093/gerona/59.3.m255.

Reference Type: BACKGROUND

PMID: 15031310 (View on PubMed)

Gill TM, Gahbauer EA, Allore HG, Han L. Transitions between frailty states among community-living older persons. Arch Intern Med. 2006 Feb 27;166(4):418-23. doi: 10.1001/archinte.166.4.418.

Reference Type: BACKGROUND

PMID: 16505261 (View on PubMed)

Gitlin LN, Hauck WW, Dennis MP, Winter L, Hodgson N, Schinfeld S. Long-term effect on mortality of a home intervention that reduces functional difficulties in older adults: results from a randomized trial. J Am Geriatr Soc. 2009 Mar;57(3):476-81. doi: 10.1111/j.1532-5415.2008.02147.x. Epub 2009 Jan 23.

Reference Type: BACKGROUND

PMID: 19187417 (View on PubMed)

LIFE Study Investigators; Pahor M, Blair SN, Espeland M, Fielding R, Gill TM, Guralnik JM, Hadley EC, King AC, Kritchevsky SB, Maraldi C, Miller ME, Newman AB, Rejeski WJ, Romashkan S, Studenski S. Effects of a physical activity intervention on measures of physical performance: Results of the lifestyle interventions and independence for Elders Pilot (LIFE-P) study. J Gerontol A Biol Sci Med Sci. 2006 Nov;61(11):1157-65. doi: 10.1093/gerona/61.11.1157.

Reference Type: BACKGROUND

PMID: 17167156 (View on PubMed)

Marshall SJ, Levy SS, Tudor-Locke CE, Kolkhorst FW, Wooten KM, Ji M, Macera CA, Ainsworth BE. Translating physical activity recommendations into a pedometer-based step goal: 3000 steps in 30 minutes. Am J Prev Med. 2009 May;36(5):410-5. doi: 10.1016/j.amepre.2009.01.021.

Reference Type: BACKGROUND

PMID: 19362695 (View on PubMed)

Montero-Odasso M, Schapira M, Soriano ER, Varela M, Kaplan R, Camera LA, Mayorga LM. Gait velocity as a single predictor of adverse events in healthy seniors aged 75 years and older. J Gerontol A Biol Sci Med Sci. 2005 Oct;60(10):1304-9. doi: 10.1093/gerona/60.10.1304.

Reference Type: BACKGROUND

PMID: 16282564 (View on PubMed)

Nelson ME, Layne JE, Bernstein MJ, Nuernberger A, Castaneda C, Kaliton D, Hausdorff J, Judge JO, Buchner DM, Roubenoff R, Fiatarone Singh MA. The effects of multidimensional home-based exercise on functional performance in elderly people. J Gerontol A Biol Sci Med Sci. 2004 Feb;59(2):154-60. doi: 10.1093/gerona/59.2.m154.

Reference Type: BACKGROUND

PMID: 14999030 (View on PubMed)

Ni Scanaill C, Carew S, Barralon P, Noury N, Lyons D, Lyons GM. A review of approaches to mobility telemonitoring of the elderly in their living environment. Ann Biomed Eng. 2006 Apr;34(4):547-63. doi: 10.1007/s10439-005-9068-2. Epub 2006 Mar 21.

Reference Type: BACKGROUND

PMID: 16550450 (View on PubMed)

Penninx BW, Messier SP, Rejeski WJ, Williamson JD, DiBari M, Cavazzini C, Applegate WB, Pahor M. Physical exercise and the prevention of disability in activities of daily living in older persons with osteoarthritis. Arch Intern Med. 2001 Oct 22;161(19):2309-16. doi: 10.1001/archinte.161.19.2309.

Reference Type: BACKGROUND

PMID: 11606146 (View on PubMed)

Sabatini AM, Martelloni C, Scapellato S, Cavallo F. Assessment of walking features from foot inertial sensing. IEEE Trans Biomed Eng. 2005 Mar;52(3):486-94. doi: 10.1109/TBME.2004.840727.

Reference Type: BACKGROUND

PMID: 15759579 (View on PubMed)

Santos-Eggimann B, Cuenoud P, Spagnoli J, Junod J. Prevalence of frailty in middle-aged and older community-dwelling Europeans living in 10 countries. J Gerontol A Biol Sci Med Sci. 2009 Jun;64(6):675-81. doi: 10.1093/gerona/glp012. Epub 2009 Mar 10.

Reference Type: BACKGROUND

PMID: 19276189 (View on PubMed)

Savolainen L, Hanson E, Magnusson L, Gustavsson T. An Internet-based videoconferencing system for supporting frail elderly people and their carers. J Telemed Telecare. 2008;14(2):79-82. doi: 10.1258/jtt.2007.070601.

Reference Type: BACKGROUND

PMID: 18348753 (View on PubMed)

Tien I, Glaser SD, Bajcsy R, Goodin DS, Aminoff MJ. Results of using a wireless inertial measuring system to quantify gait motions in control subjects. IEEE Trans Inf Technol Biomed. 2010 Jul;14(4):904-15. doi: 10.1109/TITB.2009.2021650. Epub 2009 May 5.

Reference Type: BACKGROUND

PMID: 19423449 (View on PubMed)

Wu G, Keyes LM. Group tele-exercise for improving balance in elders. Telemed J E Health. 2006 Oct;12(5):561-70. doi: 10.1089/tmj.2006.12.561.

Reference Type: BACKGROUND

PMID: 17042710 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36260404 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28582238 (View on PubMed)

Other Identifiers

13 6991 17

Identifier Type: -

Identifier Source: org_study_id