Lumbar Spinal StenosisNCT06628245
The Dubousset Functional Test in Lumbar Spinal Stenosis
An observational study of Lumbar Spinal Stenosis, run by Alanya Alaaddin Keykubat University.
Trial summary
The aim of this study is to investigate the validity and reliability of Dubousset Functional Test in the patients with lumbar spinal stenosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sixty patients with lumbar spinal stenosis.
Who may be able to join
- Patients aged 18-65 years, diagnosed with chronic pain (more than three months) due to lumbar spinal stenosis.
Who cannot join
- Those with fractures, pregnancy, a disease that would prevent physical exertion, those with a body mass index (BMI) of 40 kg/m2 and above, and those with major musculoskeletal or neurological disorders that cause gait disturbance will be excluded from the study.
About this study
Official title: Validity and Reliability of Dubousset Functional Test in Lumbar Spinal Stenosis
The aim of this study is to investigate the validity and reliability of Dubousset Functional Test in the patients with lumbar spinal stenosis.
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Lumbar Spinal Stenosis, Functional Status, Dubousset Functional Test, Reliability, Validity
- Medical subject headings
- Spinal Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Dubousset Functional Test
The four test components included the Up and Walking Test (unassisted sit-to-stand from a chair, walk forward/backward 5 meters [no turn], then unassisted stand-to-sit), Steps Test (ascend three steps, turn, descend three steps), Down and Sitting Test (stand-to-ground, followed by ground-to-stand, with assistance as needed), and Dual-Tasking Test (walk 5 meters forwards and back while counting down from 50 by 2).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study startDec 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Unal, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628245
- Sponsor's protocol ID
- 30.09.2024/DFT
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Dubousset Functional Test in Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT06628245
- Acronym / sponsor ID
- 30.09.2024/DFT
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Lumbar Spinal Stenosis, Functional Status, Dubousset Functional Test, Reliability, Validity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 4 Oct 2024 (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 aim of this study is to investigate the validity and reliability of Dubousset Functional Test in the patients with lumbar spinal stenosis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sixty patients with lumbar spinal stenosis.
Key inclusion criteria (1 listed)
- Patients aged 18-65 years, diagnosed with chronic pain (more than three months) due to lumbar spinal stenosis.
Key exclusion criteria (1 listed)
- Those with fractures, pregnancy, a disease that would prevent physical exertion, those with a body mass index (BMI) of 40 kg/m2 and above, and those with major musculoskeletal or neurological disorders that cause gait disturbance will be excluded from 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.
Primary outcome
Dubousset Functional Test
Time frame: 10 minutes
The four test components included the Up and Walking Test (unassisted sit-to-stand from a chair, walk forward/backward 5 meters [no turn], then unassisted stand-to-sit), Steps Test (ascend three steps, turn, descend three steps), Down and Sitting Test (stand-to-ground, followed by ground-to-stand, with assistance as needed), and Dual-Tasking Test (walk 5 meters forwards and back while counting down from 50 by 2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis, run by Alanya Alaaddin Keykubat University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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 Functional Test (time frame: 10 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 4 Oct 2024; AzTrials last refreshed its copy on 30 Oct 2026.