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Analysis of the French Balance and Daily Life (EVQ) Questionnaire for Evaluation of Balance in the Frail Elderly (EVQ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03343821
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Tracking Information
First Submitted Date November 10, 2017
First Posted Date November 17, 2017
Last Update Posted Date August 5, 2019
Actual Study Start Date January 30, 2018
Actual Primary Completion Date July 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 10, 2017)
  • 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03343821 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 22, 2017)
  • Comparison of EVQ score to Timed Up and Go test [ Time Frame: Day 0 ]
    Timed Up and Go test (seconds)
  • Comparison of EVQ score to Timed Up and Go test [ Time Frame: Month 1 ]
    Timed Up and Go test (seconds)
  • Comparison of EVQ to unipedal stance test [ Time Frame: Day 0 ]
    Unipedal stance test (seconds)
  • Comparison of EVQ to unipedal stance test [ Time Frame: Month 1 ]
    Unipedal stance test (seconds)
  • Comparison of EVQ to Sternal Push Test [ Time Frame: Day 0 ]
    Sternal Push Test
  • Comparison of EVQ to Sternal Push Test [ Time Frame: Month 1 ]
    Sternal Push Test
  • Comparison of EVQ to Walking and talking test [ Time Frame: Day 0 ]
    Walking and talking test
  • Comparison of EVQ to Walking and talking test [ Time Frame: Month 1 ]
    Walking and talking test
  • Sensitivity of Balance and Daily Life Questionnaire to change [ Time Frame: Month 1 ]
    Balance and Daily Life Questionnaire given 30 days apart
Original Secondary Outcome Measures
 (submitted: November 10, 2017)
  • Comparison of EVQ score to Timed Up and Go test [ Time Frame: Day 0 ]
    Timed Up and Go test (seconds)
  • Comparison of EVQ score to Timed Up and Go test [ Time Frame: Month 1 ]
    Timed Up and Go test (seconds)
  • Comparison of EVQ to unipedal stance test [ Time Frame: Day 0 ]
    Unipedal stance test (seconds)
  • Comparison of EVQ to unipedal stance test [ Time Frame: Month 1 ]
    Unipedal stance test (seconds)
  • Comparison of EVQ to Sternal Push Test [ Time Frame: Day 0 ]
    Sternal Push Test
  • Comparison of EVQ to Sternal Push Test [ Time Frame: Month 1 ]
    Sternal Push Test
  • Comparison of EVQ to Walking and talking test [ Time Frame: Day 0 ]
    Walking and talking test
  • Comparison of EVQ to Walking and talking test [ Time Frame: Month 1 ]
    Walking and talking test
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Analysis of the French Balance and Daily Life (EVQ) Questionnaire for Evaluation of Balance in the Frail Elderly
Official Title Analysis of the French Balance and Daily Life (EVQ) Questionnaire for Evaluation of Balance in the Frail Elderly
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Accidental Fall
Intervention Other: Balance and daily life questionnaire
Patients complete questionnaire
Study Groups/Cohorts Frail elderly patient
Intervention: Other: Balance and daily life questionnaire
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 10, 2017)
140
Original Estimated Enrollment Same as current
Actual Study Completion Date July 2, 2019
Actual Primary Completion Date July 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03343821
Other Study ID Numbers NIMAO/2016/CEDMH-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire de Nīmes
Study Sponsor Centre Hospitalier Universitaire de Nīmes
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire de Nīmes
Verification Date August 2019