Stroke SyndromeNCT04627558
Validity Reliability of The Dubousset Functional Test in Stroke Patients
An observational study of Stroke Syndrome and Balance; Distorted, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
Increased muscle tone, decreased normal range of motion, and functional impairments may result in decreased load on the affected limb, deviations in gait patterns, balance and coordination disorders in individuals with stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke Syndrome, Balance; Distorted, Walking, Difficulty
- What is being tested?
- stroke patients, balance assessment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Nov 2020to 15 Feb 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke patients
Who may be able to join
- 18 years or older,
- Getting a diagnosis of stroke,
- Not having cooperation and communication problems
- To be able to walk 10 m independently with or without device
Who cannot join
- Have a neurological or orthopedic problem other than stroke that will affect functionality and balance
- Individuals with contraindications for advanced cardiovascular disease and mobilization will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Increased muscle tone, decreased normal range of motion, and functional impairments may result in decreased load on the affected limb, deviations in gait patterns, balance and coordination disorders in individuals with stroke.
In the literature, there are many scales that evaluate balance and functional performance in stroke. However there is no validity and reliability study of Dubousset Function Test developed to evaluate balance and functional performance of stroke. For this reason, the aim of study is to examine the validity and reliability of Dubousset Function Test in stroke patients.
Read the detailed description
While the ambulation ability is completely lost in some patients after stroke, impaired balance reactions and increased postural oscillations cause an increase in the fear of falling and the risk of falling in stroke patients. These disturbances cause stroke patients to make more effort to balance while standing. Balance assessment performed in individuals with stroke determines the risk of falling and is important in preventing complications that may develop due to loss of balance.
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 stroke. However there is no validity and reliability study of Dubousset Function Test developed to evaluate balance and functional performance of stroke. For this reason, the aim of study is to examine the validity and reliability of Dubousset Function Test in stroke patients
- Conditions
- Stroke Syndrome, Balance; Distorted, Walking, Difficulty
- Being tested
- stroke patients, balance assessment
- Medical subject headings
- Stroke, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stroke patients, balance assessmentOther
validity relability dubousset functional test
| Study group | Role | What they receive |
|---|---|---|
| stroke patients, balance assessment | Dubousset Function Test, 3-m backwards walk test, timed up and go test,Tinnetti Balance and Gait Test, Berg BalanceTest, Functional Reach Test Receives: Other: stroke patients, balance 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 posted13 Nov 2020
- Study start6 Nov 2020
- Primary completion1 Feb 2022
- Study completion15 Feb 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 Stroke SyndromeStudies 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf Emre Bozkurt, Kırıkkale University
- Investigators
- Yusuf Emre Bozkurt, PT, Principal investigator, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627558
- Sponsor's protocol ID
- Dubousset Functional Test
- Status last verified
- Apr 2022
- First submitted
- 8 Nov 2020
- Last updated
- 19 Apr 2022
- Results posted
- 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 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity Reliability of The Dubousset Functional Test in Stroke Patients
- ClinicalTrials.gov ID
- NCT04627558
- Acronym / sponsor ID
- Dubousset Functional Test
- Conditions
- Stroke Syndrome, Balance; Distorted, Walking, Difficulty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 13 Nov 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.
Increased muscle tone, decreased normal range of motion, and functional impairments may result in decreased load on the affected limb, deviations in gait patterns, balance and coordination disorders in individuals with stroke.
In the literature, there are many scales that evaluate balance and functional performance in stroke. However there is no validity and reliability study of Dubousset Function Test developed to evaluate balance and functional performance of stroke. For this reason, the aim of study is to examine the validity and reliability of Dubousset Function Test in stroke patients.
Detailed description
While the ambulation ability is completely lost in some patients after stroke, impaired balance reactions and increased postural oscillations cause an increase in the fear of falling and the risk of falling in stroke patients. These disturbances cause stroke patients to make more effort to balance while standing. Balance assessment performed in individuals with stroke determines the risk of falling and is important in preventing complications that may develop due to loss of balance.
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 stroke. However there is no validity and reliability study of Dubousset Function Test developed to evaluate balance and functional performance of stroke. For this reason, the aim of study is to examine the validity and reliability of Dubousset Function Test in stroke patients
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke patients, balance assessment | – | Other: stroke patients, balance assessmentDubousset Function Test, 3-m backwards walk test, timed up and go test,Tinnetti Balance and Gait Test, Berg BalanceTest, Functional Reach Test |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients
Key inclusion criteria (4 listed)
- 18 years or older,
Key exclusion criteria (2 listed)
- Have a neurological or orthopedic problem other than stroke that will affect functionality and balance
- Individuals with contraindications for advanced cardiovascular disease and mobilization will not be included in the study.
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 |
|---|---|---|
| stroke patients, balance assessmentvalidity relability dubousset functional test | Other | stroke patients, balance 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 19 Apr 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
Related trials for Stroke Syndrome
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Acute Ichemic Stroke
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Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
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Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
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Not yet recruitingPhase 2
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Chronic Stroke
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.
Yusuf Emre Bozkurt, PT principal investigator
Kırıkkale 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 Stroke Syndrome and Balance; Distorted, 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 4 inclusion and 2 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 19 Apr 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 NCT04627558, 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 19 Apr 2022; AzTrials last refreshed its copy on 3 Nov 2026.