Accidental FallEVQNCT03343821
Analysis of the French Balance and Daily Life (EVQ) Questionnaire for Evaluation of Balance in the Frail Elderly
An observational study of Accidental Fall, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The Balance and Daily Life questionnaire (EVQ) observes the adaption of the patient in six scenarios of daily life; it is a measurement of falls, but also an evaluation of the modifications taken to prevent future falls. This study will analyze the robustness of this questionnaire. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Accidental Fall
- What is being tested?
- Balance and daily life questionnaire
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2018to 2 Jul 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: • Frail elderly patients over 65 years old hospitalized in the Physical Medicine and Functional Geriatric Readaptation service of the CHU Nîmes
Who may be able to join
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient is at least 65 years' old
- The patient is fragile (< 8 score ≤ 11 SEGA score) hospitalized in the Physical Medicine and Functional Geriatric Readaptation service of the CHU Nîmes
- The patient can walk autonomously for 20m (with or without a walking aid)
- The patient is allowed to weight-bear
Who cannot join
- The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent form
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- The patient is forbidden to weight-bear
- Comprehension problems preventing the accomplishment of the tasks
- Major short-term memory problems preventing the accomplishment of the tasks
Trial locations and contacts
1 site in 1 country.
About this study
The Balance and Daily Life questionnaire (EVQ) observes the adaption of the patient in six scenarios of daily life; it is a measurement of falls, but also an evaluation of the modifications taken to prevent future falls. This study will analyze the robustness of this questionnaire.
- Conditions
- Accidental Fall
- Being tested
- Balance and daily life questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance and daily life questionnaireOther
Patients complete questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Frail elderly patient | Not described Receives: Other: Balance and daily life questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-evaluator reliability of Balance and Daily Life Questionnaire
Balance and Daily Life Questionnaire assessed by 2 evaluators
Measured: Day 0
Temporal stability of Balance and Daily Life Questionnaire
Balance and Daily Life Questionnaire given 3 days apart
Measured: Day 3
Secondary outcomes (9)
Comparison of EVQ score to Timed Up and Go test
Timed Up and Go test (seconds)
Measured: Day 0
Comparison of EVQ score to Timed Up and Go test
Timed Up and Go test (seconds)
Measured: Month 1
Comparison of EVQ to unipedal stance test
Unipedal stance test (seconds)
Measured: Day 0
Comparison of EVQ to unipedal stance test
Unipedal stance test (seconds)
Measured: Month 1
Comparison of EVQ to Sternal Push Test
Sternal Push Test
Measured: Day 0
Comparison of EVQ to Sternal Push Test
Sternal Push Test
Measured: Month 1
Comparison of EVQ to Walking and talking test
Walking and talking test
Measured: Day 0
Comparison of EVQ to Walking and talking test
Walking and talking test
Measured: Month 1
Sensitivity of Balance and Daily Life Questionnaire to change
Balance and Daily Life Questionnaire given 30 days apart
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start30 Jan 2018
- Primary completion2 Jul 2019
- Study completion2 Jul 2019
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 Accidental FallStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343821
- Sponsor's protocol ID
- NIMAO/2016/CEDMH-02
- Other IDs
- 2017-A01007-46
- Acronym
- EVQ
- Status last verified
- Aug 2019
- First submitted
- 10 Nov 2017
- Last updated
- 1 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Labachelerie C, Viollet E, Alonso S, Dauvergne C, Blot M, Nouvel F, Fagart W, Chevallier T, Gelis A, Dupeyron A. Development and psychometric properties of the Balance in Daily Life (BDL) scale in a population of frail older people. Maturitas. 2024 Sep;187:108064. doi: 10.1016/j.maturitas.2024.108064. Epub 2024 Jul 8.
PubMed 39029351
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the French Balance and Daily Life (EVQ) Questionnaire for Evaluation of Balance in the Frail Elderly
- ClinicalTrials.gov ID
- NCT03343821
- Acronym / sponsor ID
- EVQ / NIMAO/2016/CEDMH-02
- Conditions
- Accidental Fall
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 2 Jul 2019 (actual)
- First posted
- 17 Nov 2017 (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 Balance and Daily Life questionnaire (EVQ) observes the adaption of the patient in six scenarios of daily life; it is a measurement of falls, but also an evaluation of the modifications taken to prevent future falls. This study will analyze the robustness of this questionnaire.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frail elderly patient | – | Other: Balance and daily life questionnaire |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- • Frail elderly patients over 65 years old hospitalized in the Physical Medicine and Functional Geriatric Readaptation service of the CHU Nîmes
Key inclusion criteria (6 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient is at least 65 years' old
- The patient is fragile (< 8 score ≤ 11 SEGA score) hospitalized in the Physical Medicine and Functional Geriatric Readaptation service of the CHU Nîmes
- The patient can walk autonomously for 20m (with or without a walking aid)
Key exclusion criteria (7 listed)
- The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent form
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- The patient is forbidden to weight-bear
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 |
|---|---|---|
| Balance and daily life questionnairePatients complete questionnaire | Other | Frail elderly patient |
Primary outcome
Inter-evaluator reliability of Balance and Daily Life Questionnaire
Time frame: Day 0
Balance and Daily Life Questionnaire assessed by 2 evaluators
Temporal stability of Balance and Daily Life Questionnaire
Time frame: Day 3
Balance and Daily Life Questionnaire given 3 days apart
9 secondary outcomes
Comparison of EVQ score to Timed Up and Go test
Time frame: Day 0
Comparison of EVQ score to Timed Up and Go test
Time frame: Month 1
Comparison of EVQ to unipedal stance test
Time frame: Day 0
Comparison of EVQ to unipedal stance test
Time frame: Month 1
Comparison of EVQ to Sternal Push Test
Time frame: Day 0
Comparison of EVQ to Sternal Push Test
Time frame: Month 1
Comparison of EVQ to Walking and talking test
Time frame: Day 0
Comparison of EVQ to Walking and talking test
Time frame: Month 1
Sensitivity of Balance and Daily Life Questionnaire to change
Time frame: Month 1
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 1 Dec 2025.
- Results publication: PubMed 39029351De Labachelerie C, Viollet E, Alonso S, Dauvergne C, Blot M, Nouvel F, Fagart W, Chevallier T, Gelis A, Dupeyron A. Development and psychometric properties of the Balance in Daily Life (BDL) scale in a population of frail older people. Maturitas. 2024 Sep;187:108064. doi: 10.1016/j.maturitas.2024.108064. Epub 2024 Jul 8.
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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 Accidental Fall, run by Centre Hospitalier Universitaire de Nīmes 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 6 inclusion and 7 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 1 Dec 2025. 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?
Inter-evaluator reliability of Balance and Daily Life Questionnaire (time frame: Day 0). The study lists 2 primary outcomes in all. 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 NCT03343821, 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 1 Dec 2025.