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NCT Number: NCT05853406

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

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.

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Key information

Conditions

Aging

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Functional Reach test

Diagnostic 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 outcomes

  1. Functional Reach Test

    Time frame: 1 year

    Determination of MCID by statistical method

Secondary outcomes

  1. Functional Reach Test

    Time frame: 1 year

    Determination of MCID by Patient rating of change

  2. Functional Reach Test

    Time frame: 1 year

    Determination of MCID by Delphy Study

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume GALLIOU, MSc

CONTACT

[email protected]

0231834802

Sponsors and collaborators

Lead sponsor

Pole Sante Grace de Dieu

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 10, 2023
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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