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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03008135
Other study ID # PSPB-01-2016
Secondary ID
Status Completed
Phase N/A
First received December 16, 2016
Last updated October 26, 2017
Start date March 21, 2017
Est. completion date October 26, 2017

Study information

Verified date October 2017
Source Pole Santé Plouasne Saint Pern Becherel
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates the reliability of the French version of the "elderly mobility scale" and its correlation with the "frailty elderly scale "


Description:

The research question:

How to effectively measure the physical independence of the elderly at home and how, from this measure, the investigators can determine the fragility threshold of the elderly.

The elderly mobility scale measures the critical points of the patient's physical autonomy. This scale was developed in Great Britain. The purpose of this study is to establish the reliability of this French version scale and to study the correlation with the elderly scale fragility.

People are recruited by a Medical consultant. After consent, their frailty is measured and a prescription is done to see a Physical therapist. The physical therapist will evaluate the physical points measured/ mentioned in the Elderly Mobility Scale, twice in a week, with two different assessors.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date October 26, 2017
Est. primary completion date October 26, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria:

- living at home, more than 70 years old

Exclusion Criteria:

- current recovery for orthopaedic problems

- Cognition impairment

- all acute problems with an impairment of mobility

Study Design


Intervention

Other:
Elderly Mobility Scale
The Elderly Mobility Scale was devised to assess the mobility of fragile elderly people, and contains seven items considered as essential for performing the basic activities of the daily routine: Lying down to sitting, sitting to lying down, sitting to standing, standing, Gait/ work on body posture, timed walk (6 meters) and work on Functional Reach/movements?
Frailty scale
6 questions are asked to the person about his or her living conditions to determine the level of frailty. The scale is produced by the board "High Health Authority"

Locations

Country Name City State
France Cabinet medical Becherel
France Cabinet medical Plouasne
France Cabinet de kinésithérapie Saint Pern

Sponsors (1)

Lead Sponsor Collaborator
Pole Santé Plouasne Saint Pern Becherel

Country where clinical trial is conducted

France, 

References & Publications (25)

A. Cherubini, L. Demougeot, A. Cruz Jentoft, A. Curgunlu, J. P. Michel, H. Roberts, A. Aihie Sayer, T. Strandberg, E. Topinkova, F. M. Trotta, D. Z. B. Van Asselt, B. Vellas, D. Zekry, et M. Cesari, " Relationship between the Gérontopole Frailty Screening

Abellan van Kan G, Rolland Y, Andrieu S, Bauer J, Beauchet O, Bonnefoy M, Cesari M, Donini LM, Gillette Guyonnet S, Inzitari M, Nourhashemi F, Onder G, Ritz P, Salva A, Visser M, Vellas B. Gait speed at usual pace as a predictor of adverse outcomes in com — View Citation

C. Flahault, C. Généraux, A. Colvez, V. Royer, et S. Berthié-mourgaud, " ETUDE DE LA FIABILITE DE L ' INSTRUMENT AGGIR Reproductibilité ( test / re-test ) entre évaluateurs Dispersion des temps d ' aide requise entre Groupes Iso Ressources Enquête dans cinq départements Travail réalisé par Dans l ' Hérault Dans les Alpes marit ", 2005

C. for R. O. R. Rehabilitation Institute of Chicago, " Rehab Measures : Barthel Index Rehabilitation Measures Database ", 2014. [En ligne]. Disponible sur: http://www.rehabmeasures.org/Lists/RehabMeasures/PrintView.aspx?ID=916.

Chiu AY, Au-Yeung SS, Lo SK. A comparison of four functional tests in discriminating fallers from non-fallers in older people. Disabil Rehabil. 2003 Jan 7;25(1):45-50. — View Citation

Clegg A, Barber S, Young J, Forster A, Iliffe S. The Home-Based Older People's Exercise (HOPE) trial: study protocol for a randomised controlled trial. Trials. 2011 Jun 8;12:143. doi: 10.1186/1745-6215-12-143. — View Citation

Clegg AP, Barber SE, Young JB, Forster A, Iliffe SJ. Do home-based exercise interventions improve outcomes for frail older people? Findings from a systematic review. Rev Clin Gerontol. 2012 Feb;22(1):68-78. Epub 2012 Aug 24. — View Citation

Collard RM, Boter H, Schoevers RA, Oude Voshaar RC. Prevalence of frailty in community-dwelling older persons: a systematic review. J Am Geriatr Soc. 2012 Aug;60(8):1487-92. doi: 10.1111/j.1532-5415.2012.04054.x. Epub 2012 Aug 6. Review. — View Citation

Crocker T, Forster A, Young J, Brown L, Ozer S, Smith J, Green J, Hardy J, Burns E, Glidewell E, Greenwood DC. Physical rehabilitation for older people in long-term care. Cochrane Database Syst Rev. 2013 Feb 28;(2):CD004294. doi: 10.1002/14651858.CD004294.pub3. Review. — View Citation

Daniels R, Metzelthin S, van Rossum E, de Witte L, van den Heuvel W. Interventions to prevent disability in frail community-dwelling older persons: an overview. Eur J Ageing. 2010 Feb 9;7(1):37-55. doi: 10.1007/s10433-010-0141-9. eCollection 2010 Mar. Review. — View Citation

Downs S, Marquez J, Chiarelli P. Normative scores on the Berg Balance Scale decline after age 70 years in healthy community-dwelling people: a systematic review. J Physiother. 2014 Jun;60(2):85-9. doi: 10.1016/j.jphys.2014.01.002. Epub 2014 Jun 13. Review. — View Citation

Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. N Engl J Med. 1995 Mar 2;332(9):556-61. — View Citation

Has, " Comment repérer la fragilité en soins ambulatoires ? ", Points clés Solut. Organ. des Parcour., 2013.

Karpman C, Lebrasseur NK, Depew ZS, Novotny PJ, Benzo RP. Measuring gait speed in the out-patient clinic: methodology and feasibility. Respir Care. 2014 Apr;59(4):531-7. doi: 10.4187/respcare.02688. Epub 2013 Aug 27. — View Citation

Lihavainen K, Sipilä S, Rantanen T, Kauppinen M, Sulkava R, Hartikainen S. Effects of comprehensive geriatric assessment and targeted intervention on mobility in persons aged 75 years and over: a randomized controlled trial. Clin Rehabil. 2012 Apr;26(4):314-26. doi: 10.1177/0269215511423269. Epub 2011 Oct 17. — View Citation

Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022. — View Citation

Rolland Y, Benetos A, Gentric A, Ankri J, Blanchard F, Bonnefoy M, de Decker L, Ferry M, Gonthier R, Hanon O, Jeandel C, Nourhashemi F, Perret-Guillaume C, Retornaz F, Bouvier H, Ruault G, Berrut G. [Frailty in older population: a brief position paper fro — View Citation

S. C. B. Ennie, K. A. B. Runer, et A. L. D. Izon, " Measurements of Balance : Comparaison of the Timed "up and Go" Test and Functional Reach Test with the Berg Balance Scale ", J. Phys. Ther. Sci., vol. 15, p. 93-97, 2003.

Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903. — View Citation

Smith, " Validation and Reliability of the Elderly Mobility Scale ", Physiotherapy, vol. 80 (11), no June 2012, p. 744-747, 1994.

Stineman MG, Shea JA, Jette A, Tassoni CJ, Ottenbacher KJ, Fiedler R, Granger CV. The Functional Independence Measure: tests of scaling assumptions, structure, and reliability across 20 diverse impairment categories. Arch Phys Med Rehabil. 1996 Nov;77(11):1101-8. — View Citation

Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JA — View Citation

Thomas JI, Lane JV. A pilot study to explore the predictive validity of 4 measures of falls risk in frail elderly patients. Arch Phys Med Rehabil. 2005 Aug;86(8):1636-40. — View Citation

Wrisley DM, Kumar NA. Functional gait assessment: concurrent, discriminative, and predictive validity in community-dwelling older adults. Phys Ther. 2010 May;90(5):761-73. doi: 10.2522/ptj.20090069. Epub 2010 Apr 1. — View Citation

Yu MS, Chan CC, Tsim RK. Usefulness of the Elderly Mobility Scale for classifying residential placements. Clin Rehabil. 2007 Dec;21(12):1114-20. — View Citation

* Note: There are 25 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary inter-rater Reliability intraclass correlation coefficient with data : Elderly Mobility Scale score between rater one and rater two Time Frame: Up to One week
Secondary Concurrent Validity correlation coefficient between Elderly Mobility Scale and Frailty scale Time Frame: Up to One week
Secondary sensibility and specificity sensibility and specificity of Elderly Mobility Scale regarding Frailty Time Frame: Up to One week
Secondary Receiver Operating Curve and cut-off score Determination of a cut-off score for Elderly Mobility Scale as a screening tool to detect the frailty by use of Receiver Operating Characteristics curve Time Frame: Up to One week
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