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Recruiting NCT05853406

Determination of a Minimal Clinically Important Difference of the "Functional Reach Test" in the Elderly.

Observational Aging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Functional Reach test.
Who it may be relevant to
Registry conditions: Aging. Basic parameters: 65 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The main objective of the study is to determine the Minimal Clinically Important Difference of the "Functional Reach Test" in the Elderly by a statistical method. The first secondary objective of the study is to determine the Minimal Clinically Important Difference by the Anchor method based on a qualitative assessment by the patients of their own response. The second secondary objective is to determine the Minimal Clinically Important Difference by the Delphi method, based on the search for a consensus between physiotherapists specializing in geriatrics.

Detailed description

The French population is aging, and geriatric rehabilitation care must adapt to this growing population. The functional reach test is a common clinical test in geriatrics. It helps to determine the risk of falling. However, its metrological qualities are not all determined. The Minimal Clinically Important Difference (MCID) is in particular unknown for this test. The MCID of a test makes it possible to personalize in a way more in-depth evaluation of physiotherapy treatment. So it is necessary to characterize this essential metrological determinant of a common balance skills assessment tool.

Interventions

  • Diagnostic test Functional Reach test
    The determination by statistical research is carried out during a usual physiotherapy assessment of the volunteers. Data patient demographics and standard tests (FRT, Tinetti test, Timed Up and Go test, unipodal station) will be noted. A satisfaction questionnaire inspired by Patient rating of change will be sent to participants for the determination of the MCID by ANCHOR method. Concerning the Delphi method, a questionnaire will be sent to physiotherapists with proven geriatric activity.

Primary outcome measures

  • Functional Reach Test [Time frame: 1 year]
Secondary outcome measures (2)
  • Functional Reach Test [Time frame: 1 year]
  • Functional Reach Test [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • People over 65 years old
  • People in care with balance problems

Exclusion criteria

  • People in an emergency situation
  • People unable to give their consent (including people under guardianship)
  • Patients already involved in another study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • PSLA GDD — Caen

Publications

  • Rosa MV, Perracini MR, Ricci NA. Usefulness, assessment and normative data of the Functional Reach Test in older adults: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2019 Mar-Apr;81:149-170. doi: 10.1016/j.archger.2018.11.015. Epub 2018 Dec 7. PMID 30593986

Identifiers

NCT: NCT05853406 · 20230102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗