NCT03343821

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 30, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2019

Completed
Last Updated

December 1, 2025

Status Verified

August 1, 2019

Enrollment Period

1.4 years

First QC Date

November 10, 2017

Last Update Submit

November 24, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Inter-evaluator reliability of Balance and Daily Life Questionnaire

    Balance and Daily Life Questionnaire assessed by 2 evaluators

    Day 0

  • Temporal stability of Balance and Daily Life Questionnaire

    Balance and Daily Life Questionnaire given 3 days apart

    Day 3

Secondary Outcomes (9)

  • Comparison of EVQ score to Timed Up and Go test

    Day 0

  • Comparison of EVQ score to Timed Up and Go test

    Month 1

  • Comparison of EVQ to unipedal stance test

    Day 0

  • Comparison of EVQ to unipedal stance test

    Month 1

  • Comparison of EVQ to Sternal Push Test

    Day 0

  • +4 more secondary outcomes

Study Arms (1)

Frail elderly patient

Other: Balance and daily life questionnaire

Interventions

Patients complete questionnaire

Frail elderly patient

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

Related Publications (1)

  • 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.

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2017

First Posted

November 17, 2017

Study Start

January 30, 2018

Primary Completion

July 2, 2019

Study Completion

July 2, 2019

Last Updated

December 1, 2025

Record last verified: 2019-08

Locations