AgingNCT05853406
Determination of a Minimal Clinically Important Difference of the "Functional Reach Test" in the Elderly.
An observational study of Aging, run by Pole Sante Grace de Dieu at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Aging
- What is being tested?
- Functional Reach test
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2023to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: The subjects recruited are patients aged over 65, having balance problems.
Who may be able to join
- People over 65 years old
- People in care with balance problems
Who cannot join
- People in an emergency situation
- People unable to give their consent (including people under guardianship)
- Patients already involved in another study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Functional Reach test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Reach testDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Reach Test
Determination of MCID by statistical method
Measured: 1 year
Secondary outcomes (2)
Functional Reach Test
Determination of MCID by Patient rating of change
Measured: 1 year
Functional Reach Test
Determination of MCID by Delphy Study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Jun 2023
- Primary completion1 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pole Sante Grace de Dieu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853406
- Sponsor's protocol ID
- 20230102
- Status last verified
- Sep 2026
- First submitted
- 1 May 2023
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30593986
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of a Minimal Clinically Important Difference of the "Functional Reach Test" in the Elderly.
- ClinicalTrials.gov ID
- NCT05853406
- Acronym / sponsor ID
- 20230102
- Conditions
- Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pole Sante Grace de DieuUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The subjects recruited are patients aged over 65, having balance problems.
Key inclusion criteria (2 listed)
- People over 65 years old
- People in care with balance problems
Key exclusion criteria (3 listed)
- People in an emergency situation
- People unable to give their consent (including people under guardianship)
- Patients already involved in another study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Reach testThe 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. | Diagnostic test | – |
Primary outcome
Functional Reach Test
Time frame: 1 year
Determination of MCID by statistical method
2 secondary outcomes
Functional Reach Test
Time frame: 1 year
Functional Reach Test
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Background: PubMed 30593986Rosa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by Pole Sante Grace de Dieu at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Reach Test (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05853406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.