Determination of a Minimal Clinically Important Difference of the "Functional Reach Test" in the Elderly.
1 other identifier
observational
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2023
CompletedFirst Posted
Study publicly available on registry
May 10, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedNovember 5, 2024
November 1, 2024
2.1 years
May 1, 2023
November 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Functional Reach Test
Determination of MCID by statistical method
1 year
Secondary Outcomes (2)
Functional Reach Test
1 year
Functional Reach Test
1 year
Interventions
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.
Eligibility Criteria
The subjects recruited are patients aged over 65, having balance problems.
You may qualify if:
- People over 65 years old
- People in care with balance problems
You may not qualify if:
- People in an emergency situation
- People unable to give their consent (including people under guardianship)
- Patients already involved in another study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PSLA GDD
Caen, 14000, France
Related 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.
PMID: 30593986BACKGROUND
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2023
First Posted
May 10, 2023
Study Start
June 1, 2023
Primary Completion
July 1, 2025
Study Completion
December 1, 2025
Last Updated
November 5, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share