Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 27 of 51656 for:    questionnaire

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

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.

Condition or disease Intervention/treatment
Accidental Fall Other: Balance and daily life questionnaire

Layout table for study information
Study Type : Observational
Actual Enrollment : 140 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Analysis of the French Balance and Daily Life (EVQ) Questionnaire for Evaluation of Balance in the Frail Elderly
Actual Study Start Date : January 30, 2018
Actual Primary Completion Date : July 2, 2019
Actual Study Completion Date : July 2, 2019

Group/Cohort Intervention/treatment
Frail elderly patient Other: Balance and daily life questionnaire
Patients complete questionnaire




Primary Outcome Measures :
  1. Inter-evaluator reliability of Balance and Daily Life Questionnaire [ Time Frame: Day 0 ]
    Balance and Daily Life Questionnaire assessed by 2 evaluators

  2. Temporal stability of Balance and Daily Life Questionnaire [ Time Frame: Day 3 ]
    Balance and Daily Life Questionnaire given 3 days apart


Secondary Outcome Measures :
  1. Comparison of EVQ score to Timed Up and Go test [ Time Frame: Day 0 ]
    Timed Up and Go test (seconds)

  2. Comparison of EVQ score to Timed Up and Go test [ Time Frame: Month 1 ]
    Timed Up and Go test (seconds)

  3. Comparison of EVQ to unipedal stance test [ Time Frame: Day 0 ]
    Unipedal stance test (seconds)

  4. Comparison of EVQ to unipedal stance test [ Time Frame: Month 1 ]
    Unipedal stance test (seconds)

  5. Comparison of EVQ to Sternal Push Test [ Time Frame: Day 0 ]
    Sternal Push Test

  6. Comparison of EVQ to Sternal Push Test [ Time Frame: Month 1 ]
    Sternal Push Test

  7. Comparison of EVQ to Walking and talking test [ Time Frame: Day 0 ]
    Walking and talking test

  8. Comparison of EVQ to Walking and talking test [ Time Frame: Month 1 ]
    Walking and talking test

  9. Sensitivity of Balance and Daily Life Questionnaire to change [ Time Frame: Month 1 ]
    Balance and Daily Life Questionnaire given 30 days apart



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343821


Locations
Layout table for location information
France
CHU Nimes
Nîmes, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03343821     History of Changes
Other Study ID Numbers: NIMAO/2016/CEDMH-02
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No