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AzTrials

Locomotor ActivityNCT03008135

Reliability and Validity of the Elderly Mobility Scale, French Version

An observational study of Locomotor Activity and Functionally-Impaired Elderly, run by Pole Santé Plouasne Saint Pern Becherel at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 70 years and olderHealthy volunteers can take part
What is being tested?
Elderly Mobility Scale and Frailty scale
How many people
25 participants
Where
3 sitesFrance
Study dates
21 Mar 2017to 26 Oct 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Study population: People living in their home, more than 70 years old, alone or not.

Who may be able to join

  • living at home, more than 70 years old

Who cannot join

  • current recovery for orthopaedic problems
  • Cognition impairment
  • all acute problems with an impairment of mobility

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Cabinet medical

    Bécherel, 35190

  • Cabinet medical

    Plouasne, 22830

  • Cabinet de kinésithérapie

    Saint-Pern, 35190

Other trials in France

About this study

Official title: Reliability and Validity of the Elderly Mobility Scale for Frailty People Living at Home, French Version

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

Read the detailed 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.

Being tested
Elderly Mobility Scale, Frailty scale

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elderly Mobility ScaleOther

    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 scaleOther

    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"

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. inter-rater Reliability

    intraclass correlation coefficient with data : Elderly Mobility Scale score between rater one and rater two

    Measured: Time Frame: Up to One week

Secondary outcomes (3)

  1. Concurrent Validity

    correlation coefficient between Elderly Mobility Scale and Frailty scale

    Measured: Time Frame: Up to One week

  2. sensibility and specificity

    sensibility and specificity of Elderly Mobility Scale regarding Frailty

    Measured: Time Frame: Up to One week

  3. 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

    Measured: Time Frame: Up to One week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2017 (estimated)
  2. Study start21 Mar 2017
  3. Primary completion26 Oct 2017
  4. Study completion26 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03008135
Sponsor's protocol ID
PSPB-01-2016
Status last verified
Oct 2017
First submitted
16 Dec 2016
Last updated
30 Oct 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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;2013(2):CD004294. doi: 10.1002/14651858.CD004294.pub3.

    PubMed 23450551

  • Lihavainen K, Sipila 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.

    PubMed 22007041

  • 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.

    PubMed 28798616

  • 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.

    PubMed 21651805

  • 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. doi: 10.1017/S0959259811000165. Epub 2012 Aug 24.

    PubMed 27226701

  • 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.

    PubMed 23764209

  • 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. doi: 10.1056/NEJM199503023320902.

    PubMed 7838189

  • 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.

    PubMed 10960937

  • 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.

    PubMed 24952835

  • 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.

  • 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.

    PubMed 23983271

  • 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. doi: 10.1016/s0003-9993(96)90130-6.

    PubMed 8931518

  • 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

  • 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.

  • Yu MS, Chan CC, Tsim RK. Usefulness of the Elderly Mobility Scale for classifying residential placements. Clin Rehabil. 2007 Dec;21(12):1114-20. doi: 10.1177/0269215507080789.

    PubMed 18042607

Questions about this trial

What is this clinical trial studying?

An observational study of Locomotor Activity and Functionally-Impaired Elderly, run by Pole Santé Plouasne Saint Pern Becherel at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

inter-rater Reliability (time frame: Time Frame: Up to One week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03008135, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017.

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