Parkinson DiseaseNCT04622657
Validity Reliability of The Dubousset Functional Test in Parkinson Disease
A study testing dubousset functional test in people with Parkinson Disease and Balance; Distorted, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
In order to achieve collaborative patient-centered rehabilitation in Parkinson's disease, detailed evaluation of walking and balance in evaluating the perceived difficulty in daily life is important to evaluate the progression of the disease and its response to treatments. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease, Balance; Distorted, Fall
- What is being tested?
- dubousset functional test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2020to 1 Apr 2022
- Phase
- Interventional
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with Parkinson's Disease (Hoehn Yahr level (1-3)
- Volunteering to participate in research and approving the informed consent form Being over the age of 40
- Using stable Parkinson's Disease medication for at least 4 weeks
- No cooperation and communication problems
Who cannot join
- • Individuals with any other neurological and orthopedic problems Uncontrollable hypertension To your serious disk Significant comorbidity affecting balance and gait
- Those with cooperation and communication problems
Trial locations and contacts
1 site in 1 country.
About this study
In order to achieve collaborative patient-centered rehabilitation in Parkinson's disease, detailed evaluation of walking and balance in evaluating the perceived difficulty in daily life is important to evaluate the progression of the disease and its response to treatments.
In the literature, there are many scales that evaluate balance and functional performance in Parkinson Disease. However there is no validity and reliability study of Dubousset Function Test developed to evaluate balance and functional performance of Parkinson Disease. For this reason, the aim of study is to examine the validity and reliability of Dubousset Function Test in Parkinson Disease.
Read the detailed description
Balance disorders are very common in patients with Parkinson's, and these disorders significantly affect the patient's body alignment and participation. Especially during walking, balance disorders occur, resulting in falls, disability and injury in the advanced stage of the disease. As a result of these losses in patients, falls can be seen, and the severity of disability that increases with age affects the quality of life of individuals by affecting their living in their own homes.
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 Parkinson Disease. However there is no validity and reliability study of Dubousset Function Test developed to evaluate balance and functional performance of Parkinson Disease. For this reason, the aim of study is to examine the validity and reliability of Dubousset Function Test in Parkinson Disease.
- Being tested
- dubousset functional test
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dubousset functional testOther
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 |
|---|---|---|
| parkinson disease | Experimental | Assessment Receives: Other: dubousset functional test |
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: through study completion, an average of 1 year
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: through study completion, an average of 1 year
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: through study completion, an average of 1 year
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: through study completion, an average of 1 year
Funtional Reach Test
It is used to measure both the balance of the individual functionally and the amount of dynamic reach It is used to measure both the balance of the individual functionally and the amount of dynamic reach
Measured: through study completion, an average of 1 year
Berg Balance Test
The BBS consists of 14 items to directly monitor the maintenance of body balance during performance
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start25 Oct 2020
- Primary completion1 Apr 2022
- Study completion1 Apr 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 Parkinson DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Abit Kocaman, Kırıkkale University
- Investigators
- Ayşe Abit Kocaman, PhD, Principal investigator, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622657
- Sponsor's protocol ID
- Parkinson Disease Assesment
- Status last verified
- Apr 2022
- First submitted
- 29 Oct 2020
- Last updated
- 12 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 12 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 Parkinson Disease
- ClinicalTrials.gov ID
- NCT04622657
- Acronym / sponsor ID
- Parkinson Disease Assesment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 25 Oct 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 10 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.
In order to achieve collaborative patient-centered rehabilitation in Parkinson's disease, detailed evaluation of walking and balance in evaluating the perceived difficulty in daily life is important to evaluate the progression of the disease and its response to treatments.
In the literature, there are many scales that evaluate balance and functional performance in Parkinson Disease. However there is no validity and reliability study of Dubousset Function Test developed to evaluate balance and functional performance of Parkinson Disease. For this reason, the aim of study is to examine the validity and reliability of Dubousset Function Test in Parkinson Disease.
Detailed description
Balance disorders are very common in patients with Parkinson's, and these disorders significantly affect the patient's body alignment and participation. Especially during walking, balance disorders occur, resulting in falls, disability and injury in the advanced stage of the disease. As a result of these losses in patients, falls can be seen, and the severity of disability that increases with age affects the quality of life of individuals by affecting their living in their own homes.
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 Parkinson Disease. However there is no validity and reliability study of Dubousset Function Test developed to evaluate balance and functional performance of Parkinson Disease. For this reason, the aim of study is to examine the validity and reliability of Dubousset Function Test in Parkinson Disease.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| parkinson disease | Experimental | Other: dubousset functional testAssessment |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being diagnosed with Parkinson's Disease (Hoehn Yahr level (1-3)
- Volunteering to participate in research and approving the informed consent form Being over the age of 40
- Using stable Parkinson's Disease medication for at least 4 weeks
- No cooperation and communication problems
Key exclusion criteria (2 listed)
- • Individuals with any other neurological and orthopedic problems Uncontrollable hypertension To your serious disk Significant comorbidity affecting balance and gait
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 |
|---|---|---|
| dubousset functional testDubousset Function Test, 3-m backwards walk test, timed up and go test,Tinnetti Balance and Gait Test, Berg BalanceTest, Functional Reach Test | Other | parkinson disease |
Primary outcome
Dubousset Function Test
Time frame: through study completion, an average of 1 year
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: through study completion, an average of 1 year
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: through study completion, an average of 1 year
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: through study completion, an average of 1 year
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.
Funtional Reach Test
Time frame: through study completion, an average of 1 year
It is used to measure both the balance of the individual functionally and the amount of dynamic reach It is used to measure both the balance of the individual functionally and the amount of dynamic reach
Berg Balance Test
Time frame: through study completion, an average of 1 year
The BBS consists of 14 items to directly monitor the maintenance of body balance during performance
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 12 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
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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.
Ayşe Abit Kocaman, PhD 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?
A study testing dubousset functional test in people with Parkinson Disease 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 12 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: through study completion, an average of 1 year). 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 NCT04622657, 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 12 Apr 2022.