Older People--Abuse ofNCT04334746
The Discriminative Ability of the Four Balance Measures for Fall History
An observational study of Older People--Abuse of and Balance; Distorted, run by Ordu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older People--Abuse of, Balance; Distorted, Fall
- What is being tested?
- Balance measurement tools
- How many people
- 351 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Oct 2020to 15 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Community-dwelling older adults
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Older People--Abuse of, Balance; Distorted, Fall
- Being tested
- Balance measurement tools
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance measurement toolsOther
Timed Up and Go Test Functional Reach Test One-leg Stance Test Berg Balance Scale
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 minutes
Secondary outcomes (4)
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.
Measured: 1 minute
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.
Measured: 20 minutes
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.
Measured: 3 minutes
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
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start6 Oct 2020
- Primary completion30 Jan 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older People--Abuse ofStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University, Giresun University
- Responsible party
- Principal investigator, Sevim ACARÖZ CANDAN, Ordu University
- Investigators
- Sevim Acaröz Candan, PhD, Study director, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334746
- Sponsor's protocol ID
- OrduU8
- Status last verified
- Mar 2022
- First submitted
- 2 Apr 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Discriminative Ability of the Four Balance Measures for.the Previous Fall Experience in Türkish Community-dwelling Older Adults
- ClinicalTrials.gov ID
- NCT04334746
- Acronym / sponsor ID
- OrduU8
- Conditions
- Older People--Abuse of, Balance; Distorted, Fall
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University, Giresun University
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Community-dwelling older adults
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance measurement toolsTimed Up and Go Test Functional Reach Test One-leg Stance Test Berg Balance Scale | Other | – |
Primary outcome
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).
4 secondary outcomes
One-leg Stance test
Time frame: 1 minute
Berg Balance Scale
Time frame: 20 minutes
Timed Up and Go Test
Time frame: 3 minutes
Functional Reach Test
Time frame: 2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevim Acaröz Candan, PhD study director
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Older People--Abuse of and Balance; Distorted, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall History (time frame: 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.