- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03343821
Analysis of the French Balance and Daily Life (EVQ) Questionnaire for Evaluation of Balance in the Frail Elderly (EVQ)
August 2, 2019 updated by: Centre Hospitalier Universitaire de Nīmes
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
140
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nîmes, France, 30029
- Chu Nimes
-
-
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
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
• Frail elderly patients over 65 years old hospitalized in the Physical Medicine and Functional Geriatric Readaptation service of the CHU Nîmes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Frail elderly patient
|
Patients complete questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inter-evaluator reliability of Balance and Daily Life Questionnaire
Time Frame: Day 0
|
Balance and Daily Life Questionnaire assessed by 2 evaluators
|
Day 0
|
Temporal stability of Balance and Daily Life Questionnaire
Time Frame: Day 3
|
Balance and Daily Life Questionnaire given 3 days apart
|
Day 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of EVQ score to Timed Up and Go test
Time Frame: Day 0
|
Timed Up and Go test (seconds)
|
Day 0
|
Comparison of EVQ score to Timed Up and Go test
Time Frame: Month 1
|
Timed Up and Go test (seconds)
|
Month 1
|
Comparison of EVQ to unipedal stance test
Time Frame: Day 0
|
Unipedal stance test (seconds)
|
Day 0
|
Comparison of EVQ to unipedal stance test
Time Frame: Month 1
|
Unipedal stance test (seconds)
|
Month 1
|
Comparison of EVQ to Sternal Push Test
Time Frame: Day 0
|
Sternal Push Test
|
Day 0
|
Comparison of EVQ to Sternal Push Test
Time Frame: Month 1
|
Sternal Push Test
|
Month 1
|
Comparison of EVQ to Walking and talking test
Time Frame: Day 0
|
Walking and talking test
|
Day 0
|
Comparison of EVQ to Walking and talking test
Time Frame: Month 1
|
Walking and talking test
|
Month 1
|
Sensitivity of Balance and Daily Life Questionnaire to change
Time Frame: Month 1
|
Balance and Daily Life Questionnaire given 30 days apart
|
Month 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 30, 2018
Primary Completion (Actual)
July 2, 2019
Study Completion (Actual)
July 2, 2019
Study Registration Dates
First Submitted
November 10, 2017
First Submitted That Met QC Criteria
November 10, 2017
First Posted (Actual)
November 17, 2017
Study Record Updates
Last Update Posted (Actual)
August 5, 2019
Last Update Submitted That Met QC Criteria
August 2, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- NIMAO/2016/CEDMH-02
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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