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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03343821
Other study ID # NIMAO/2016/CEDMH-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 30, 2018
Est. completion date July 2, 2019

Study information

Verified date August 2019
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date July 2, 2019
Est. primary completion date July 2, 2019
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Balance and daily life questionnaire
Patients complete questionnaire

Locations

Country Name City State
France CHU Nimes Nîmes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Inter-evaluator reliability of Balance and Daily Life Questionnaire Balance and Daily Life Questionnaire assessed by 2 evaluators Day 0
Primary Temporal stability of Balance and Daily Life Questionnaire Balance and Daily Life Questionnaire given 3 days apart Day 3
Secondary Comparison of EVQ score to Timed Up and Go test Timed Up and Go test (seconds) Day 0
Secondary Comparison of EVQ score to Timed Up and Go test Timed Up and Go test (seconds) Month 1
Secondary Comparison of EVQ to unipedal stance test Unipedal stance test (seconds) Day 0
Secondary Comparison of EVQ to unipedal stance test Unipedal stance test (seconds) Month 1
Secondary Comparison of EVQ to Sternal Push Test Sternal Push Test Day 0
Secondary Comparison of EVQ to Sternal Push Test Sternal Push Test Month 1
Secondary Comparison of EVQ to Walking and talking test Walking and talking test Day 0
Secondary Comparison of EVQ to Walking and talking test Walking and talking test Month 1
Secondary Sensitivity of Balance and Daily Life Questionnaire to change Balance and Daily Life Questionnaire given 30 days apart Month 1
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