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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05853406
• Other study ID #: 20230102
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Pole Sante Grace de Dieu
• Contact: Guillaume GALLIOU, MSc
• Phone: 0231834802
• Email: guillaume.galliou[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging

Intervention

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.

Locations

Country	Name	City	State
France	PSLA GDD	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Pole Sante Grace de Dieu

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Reach Test	Determination of MCID by statistical method	1 year
Secondary	Functional Reach Test	Determination of MCID by Patient rating of change	1 year
Secondary	Functional Reach Test	Determination of MCID by Delphy Study	1 year