- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04334746
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
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
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
-
-
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
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
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
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
Investigators
- 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)
October 6, 2020
Primary Completion (Actual)
January 30, 2021
Study Completion (Actual)
February 15, 2021
Study Registration Dates
First Submitted
April 2, 2020
First Submitted That Met QC Criteria
April 2, 2020
First Posted (Actual)
April 6, 2020
Study Record Updates
Last Update Posted (Actual)
March 2, 2022
Last Update Submitted That Met QC Criteria
March 1, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Other Study ID 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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