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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04334746
Other study ID # OrduU8
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 6, 2020
Est. completion date February 15, 2021

Study information

Verified date March 2022
Source T.C. ORDU ÜNIVERSITESI
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 351
Est. completion date February 15, 2021
Est. primary completion date January 30, 2021
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Balance measurement tools
Timed Up and Go Test Functional Reach Test One-leg Stance Test Berg Balance Scale

Locations

Country Name City State
Turkey Sevim ACARÖZ CANDAN Ordu Altinordu

Sponsors (3)

Lead Sponsor Collaborator
T.C. ORDU ÜNIVERSITESI Giresun University, Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fall History 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 One-leg Stance test 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
Secondary Berg Balance Scale 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
Secondary Timed Up and Go Test 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
Secondary Functional Reach Test 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
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