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

November 15, 2023 updated by: Pole Sante Grace de Dieu

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The subjects recruited are patients aged over 65, having balance problems.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Reach Test
Time Frame: 1 year
Determination of MCID by statistical method
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Reach Test
Time Frame: 1 year
Determination of MCID by Patient rating of change
1 year
Functional Reach Test
Time Frame: 1 year
Determination of MCID by Delphy Study
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pole Sante Grace de Dieu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 1, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 20230102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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