The Discriminative Ability of the Four Balance Measures for Fall History

March 1, 2022 updated by: Sevim ACARÖZ CANDAN, T.C. ORDU ÜNİVERSİTESİ

The Discriminative Ability of the Four Balance Measures for.the Previous Fall Experience in Türkish Community-dwelling Older Adults

The fall rate is increased parallel to the aging process. The early determination and management of falls in older adults are quite crucial to preserve the independence of older adults. In the literature, there are used many measurement tools for predicting fall status. The discriminative ability of these measures is important for the accuracy of the assessment. In this study, four of the most commonly used balance measurement tools will be investigated in terms of the discriminative ability for fall status in the Turkish community-dwelling older adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
351

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

  • Turkey
    • Altinordu
      • Ordu, Altinordu, Turkey, 52100
        • Sevim ACARÖZ CANDAN

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Community-dwelling older adults

Description

Inclusion Criteria:

  • being aged 65 or above,
  • having a score of 21 or more from the Mini-Mental State Examination (MMSE) [20,23],
  • able to ambulate independently or with an assistive device.

Exclusion Criteria:

  • having visual and hearing problems that may cause restrictions in communication and also balance impairments,
  • drug use (benzodiazepine, psychotropic drugs, etc.) with adverse effects on balance and walking,
  • having any serious neurological, cardiopulmonary, or orthopedic disorders that adversely affected balance conditions.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fall History
Time Frame: 2 minutes

History of fallings will be determined through a question: "How many times have you fallen in the past year?".

According to the participants' answers, the participants will be categorized into two groups: fallers (one or more fall events) and non-fallers (no falls).
2 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
One-leg Stance test
Time Frame: 1 minute
The static balance ability will be determined by one-leg stance test. The participants will be asked to stand on her/his dominant leg as long as possible. The standing time will be recorded with a stopwatch in seconds. Higher times indicate the better balance.
1 minute
Berg Balance Scale
Time Frame: 20 minutes
This scale will be used to evaluate the balance ability. It consists 14 items which are scored from 0 to 4, for a total score of 56 points possible. Higher scores indicate better balance performance.
20 minutes
Timed Up and Go Test
Time Frame: 3 minutes
In this test, participants will be asked to stand from a chair, walk 3 meters (to a line on the floor), turn around, walk back to the chair, and sit back down. Participants are instructed to walk at a comfortable and safe pace during the Timed Up and Go Test. The participant's score is the time it takes to complete the mentioned test. Lower scores indicate better balance performance.
3 minutes
Functional Reach Test
Time Frame: 2 minutes
Functional reach will be measured by using a leveled yardstick attached to the wall at the height of the participant's right acromion. To measure the participant's reaching distance, an examiner should stand 4 feet away from the yardstick and should be record the initial and end reach positions. Participant should stand in a relaxed position with feet approximately shoulder-width apart, made a loose fist, and, without touching the wall, placed the right arm parallel to the yardstick (initial position). Participants then will be asked to reach as far forward as they could without losing their balance (end position). The position of the third metacarpal along the yardstick will be recorded at both the initial and end positions. All subjects will be supervised during the test to ensure safety. The mean difference between the initial position and the end position will be calculated as the functional reach score in centimeters. The higher score indicates
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
T.C. ORDU ÜNİVERSİTESİ

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hacettepe University
Giresun University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sevim Acaröz Candan, PhD, T.C. ORDU ÜNİVERSİTESİ

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OrduU8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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