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

NCT ID: NCT05853406

Last Updated: 2024-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Aging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pole Sante Grace de Dieu

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PSLA GDD

Caen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Guillaume GALLIOU, MSc

Role: CONTACT

0231834802

Facility Contacts

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Guillaume GALLIOU

Role: primary

0231834802

References

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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.

Reference Type BACKGROUND
PMID: 30593986 (View on PubMed)

Other Identifiers

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20230102

Identifier Type: -

Identifier Source: org_study_id

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