AgingNCT04595292
Validity Reliability of The Dubousset Functional Test in Older Adults
An observational study of Aging and Fall, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
Postural deformity and postural instability that occur with aging are risk factors for falling. In the literature, there are many scales that evaluate balance and functional performance in older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Fall, Balance; Distorted
- What is being tested?
- older adults, assessment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2020to 15 Jan 2022
- 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
- Healthy volunteers accepted
- Older adult
Study population: Individuals aged 65 and over, Volunteering to participate in research, No cooperation and communication problem
Who may be able to join
- Individuals aged 65 and over,
- Volunteering to participate in research
- No cooperation and communication problem
Who cannot join
- Individuals with neurological and orthopedic problems
- Uncontrollable hypertension
- Those with cardiac disease
- Those with cooperation and communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Postural deformity and postural instability that occur with aging are risk factors for falling.
In the literature, there are many scales that evaluate balance and functional performance in older adults. However there is no validity and reliability study of Dubousset Function Test developed to evaluate balance and functional performance of older adults. For this reason, the aim of study is to examine the validity and reliability of Dubousset Function Test in older adults.
Read the detailed description
However, postural deformity and postural instability that occur with aging are risk factors for falling. In studies examining the relationship between postural instability and spinal curvatures, it was stated that the balance and functional performance of patients with increased kyphosis were affected. Increased thoracic kyphosis and lumbar lordosis loss in geriatric individuals, degenerative spinal deformities are common and functional limitations lead to negative clinical consequences such as an increase in the risk of falls or fractures and impaired quality of life.
Dubousset Functional Test (DFT); A conceptually practical four-component assessment test has been proposed by Dr. Jean Dubousset to assess the functional capacity of adult individuals. The validity of the test was made in individuals with spinal deformity. DFT; It consists of four components: getting up from a chair without arms and walking 5 meters forward and backward, descending and climbing steps, transition from standing to sitting on the ground, and the dual task test in which the individual walks while counting down from 50 at the same time.
In the literature, there are many scales that evaluate balance and functional performance in elderly individuals.However, there is no validity and reliability study of Dubousset Function Test developed to evaluate balance and functional performance of adult individuals in elderly individuals. For this reason, the aim of study is to examine the validity and reliability of Dubousset Function Test in older adults.
- Conditions
- Aging, Fall, Balance; Distorted
- Being tested
- older adults, assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
older adults, assessmentOther
Dubousset Function Test, 3-m backwards walk test, timed up and go test,Tinnetti Balance and Gait Test, Berg BalanceTest, Functional Reach Test
| Study group | Role | What they receive |
|---|---|---|
| older adults, assessment | Not described Receives: Other: older adults, assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dubousset Function Test
The four components of the DFT included (1) the Up Walking Test: participants rose without assistance from a and seated position in a chair that did not have arms, walked 5 meters (500 cm) forward before stopping, walked backwards 5 meters, and sat again without assistance; (2) the Steps Test: from a starting position 50 cm away, volunteers climbed three stairs, turned around on the third step (top), and walked down the three steps; (3) Down and Sitting Test: from a standing position, participants sat on the ground and stood up again, using assistance as needed; (4) Dual-Tasking Test: participants walked 5 meters forward, turned around, and walked 5 meters back to the starting position while performing a working memory test (counting down from 50 by intervals of 2).
Measured: first day
timed up and go test
A standard chair is used for testing. First, the patient is asked to sit on the chair. The patient is then asked to stand up and walk regularly at a distance of 3 meters with a predetermined length, then return to the chair after 3 meters.
Measured: first day
3-m backwards walk test,
A distance of 3 m is measured and marked with black tape. Individuals are asked to follow the heel and black band.
With the 'start' command they are asked to walk backwards quickly. When the distance of 3 m is completed, a stop is instructed. Individuals are not allowed to run during the test. They are allowed to look back if they wish. The assessor walks behind individuals throughout the test. The test is repeated 3 times, the averages are recorded
Measured: first day
Tinetti Balance and Gait Test
In the test used to evaluate balance, walking score is maximum 12 points, balance score is maximum 16 points and a total of 28 points.
Measured: first day
Berg Balance Test
The BBS consists of 14 items to directly monitor the maintenance of body balance during performance
Measured: first day
Funtional Reach Test
It is used to measure both the balance of the individual functionally and the amount of dynamic reach
Measured: first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start15 Oct 2020
- Primary completion1 Jan 2022
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Abit Kocaman, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595292
- Sponsor's protocol ID
- The Dubousset Functional Test
- Status last verified
- Jan 2022
- First submitted
- 9 Oct 2020
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diebo BG, Challier V, Shah NV, Kim D, Murray DP, Kelly JJ, Lafage R, Paulino CB, Passias PG, Schwab FJ, Lafage V. The Dubousset Functional Test is a Novel Assessment of Physical Function and Balance. Clin Orthop Relat Res. 2019 Oct;477(10):2307-2315. doi: 10.1097/CORR.0000000000000820.
PubMed 31135543
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity Reliability of The Dubousset Functional Test in Older Adults
- ClinicalTrials.gov ID
- NCT04595292
- Acronym / sponsor ID
- The Dubousset Functional Test
- Conditions
- Aging, Fall, Balance; Distorted
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 20 Oct 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.
Postural deformity and postural instability that occur with aging are risk factors for falling.
In the literature, there are many scales that evaluate balance and functional performance in older adults. However there is no validity and reliability study of Dubousset Function Test developed to evaluate balance and functional performance of older adults. For this reason, the aim of study is to examine the validity and reliability of Dubousset Function Test in older adults.
Detailed description
However, postural deformity and postural instability that occur with aging are risk factors for falling. In studies examining the relationship between postural instability and spinal curvatures, it was stated that the balance and functional performance of patients with increased kyphosis were affected. Increased thoracic kyphosis and lumbar lordosis loss in geriatric individuals, degenerative spinal deformities are common and functional limitations lead to negative clinical consequences such as an increase in the risk of falls or fractures and impaired quality of life.
Dubousset Functional Test (DFT); A conceptually practical four-component assessment test has been proposed by Dr. Jean Dubousset to assess the functional capacity of adult individuals. The validity of the test was made in individuals with spinal deformity. DFT; It consists of four components: getting up from a chair without arms and walking 5 meters forward and backward, descending and climbing steps, transition from standing to sitting on the ground, and the dual task test in which the individual walks while counting down from 50 at the same time.
In the literature, there are many scales that evaluate balance and functional performance in elderly individuals.However, there is no validity and reliability study of Dubousset Function Test developed to evaluate balance and functional performance of adult individuals in elderly individuals. For this reason, the aim of study is to examine the validity and reliability of Dubousset Function Test in older adults.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| older adults, assessment | – | Other: older adults, assessment |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Individuals aged 65 and over, Volunteering to participate in research, No cooperation and communication problem
Key inclusion criteria (3 listed)
- Individuals aged 65 and over,
- Volunteering to participate in research
- No cooperation and communication problem
Key exclusion criteria (4 listed)
- Individuals with neurological and orthopedic problems
- Uncontrollable hypertension
- Those with cardiac disease
- Those with cooperation and communication problems
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 |
|---|---|---|
| older adults, assessmentDubousset Function Test, 3-m backwards walk test, timed up and go test,Tinnetti Balance and Gait Test, Berg BalanceTest, Functional Reach Test | Other | older adults, assessment |
Primary outcome
Dubousset Function Test
Time frame: first day
The four components of the DFT included (1) the Up Walking Test: participants rose without assistance from a and seated position in a chair that did not have arms, walked 5 meters (500 cm) forward before stopping, walked backwards 5 meters, and sat again without assistance; (2) the Steps Test: from a starting position 50 cm away, volunteers climbed three stairs, turned around on the third step (top), and walked down the three steps; (3) Down and Sitting Test: from a standing position, participants sat on the ground and stood up again, using assistance as needed; (4) Dual-Tasking Test: participants walked 5 meters forward, turned around, and walked 5 meters back to the starting position while performing a working memory test (counting down from 50 by intervals of 2).
timed up and go test
Time frame: first day
A standard chair is used for testing. First, the patient is asked to sit on the chair. The patient is then asked to stand up and walk regularly at a distance of 3 meters with a predetermined length, then return to the chair after 3 meters.
3-m backwards walk test,
Time frame: first day
A distance of 3 m is measured and marked with black tape. Individuals are asked to follow the heel and black band. With the 'start' command they are asked to walk backwards quickly. When the distance of 3 m is completed, a stop is instructed. Individuals are not allowed to run during the test. They are allowed to look back if they wish. The assessor walks behind individuals throughout the test. The test is repeated 3 times, the averages are recorded
Tinetti Balance and Gait Test
Time frame: first day
In the test used to evaluate balance, walking score is maximum 12 points, balance score is maximum 16 points and a total of 28 points.
Berg Balance Test
Time frame: first day
The BBS consists of 14 items to directly monitor the maintenance of body balance during performance
Funtional Reach Test
Time frame: first day
It is used to measure both the balance of the individual functionally and the amount of dynamic reach
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 21 Jan 2022.
- Background: PubMed 31135543Diebo BG, Challier V, Shah NV, Kim D, Murray DP, Kelly JJ, Lafage R, Paulino CB, Passias PG, Schwab FJ, Lafage V. The Dubousset Functional Test is a Novel Assessment of Physical Function and Balance. Clin Orthop Relat Res. 2019 Oct;477(10):2307-2315. doi: 10.1097/CORR.0000000000000820.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aging and Fall, run by Kırıkkale 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 4 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 21 Jan 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?
Dubousset Function Test (time frame: first day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04595292, which also lists 1 linked publication.
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 21 Jan 2022.