Spinal StenosisNCT06060821
Validity and Reliability of the 2-minute Step Test in Patients With Lumbar Spinal Stenosis
An observational study of Spinal Stenosis, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the validity and reliability of the 2 Minute Step Test (2MST) in patients with symptomatic degenerative lumbar spinal stenosis and to explore its correlation with objective assessment methods, namely the 2 Minute Walk Test (2MWT) and the 6 Minute Walk Test (6MWT). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Stenosis
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 31 Oct 2023
- How long will I take part?
- 1 Week
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Patients aged 18-80 who have been diagnosed with lumbar spinal stenosis based on magnetic resonance images.
Who may be able to join
- Patients aged 18-80 who have been diagnosed with lumbar spinal stenosis based on magnetic resonance images.
Who cannot join
- Uncontrolled hypertension
- Decompensated heart failure
- Presence of systemic diseases affecting lower extremity functions
- Presence of degenerative diseases affecting lower extremity functions
- Peripheral artery disease causing vascular claudication
- Psychiatric illness
Show all 9Show fewer
- Neuromuscular disease
- Pregnancy
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul
About this study
Official title: Construct Validity and Reliability of the 2-minute Step Test in Patients With Lumbar Spinal Stenosis
The aim of this study was to investigate the validity and reliability of the 2 Minute Step Test (2MST) in patients with symptomatic degenerative lumbar spinal stenosis and to explore its correlation with objective assessment methods, namely the 2 Minute Walk Test (2MWT) and the 6 Minute Walk Test (6MWT).
Read the detailed description
This cross-sectional study will include 55 volunteers aged 18-80 years who present to the Istanbul Physical Medicine and Rehabilitation Training and Research Hospital outpatient clinics and are diagnosed with Lumbar Spinal Stenosis (LSS) through MRI. The demographic characteristics of the patients will be recorded, and their walking distances will be inquired about. The severity of the disease will be determined by examining the levels of stenosis on lumbar MRI scans. All patients will be initially assessed using the 2MST (2-Minute Step Test), 2MWT (2-Minute Walk Test), 6MWT (6-Minute Walk Test), VAS (Visual Analogue Scale), and ODI (Oswestry Disability Index). To measure test-retest reliability, the 2MST will be administered again with a 7-day interval between assessments.
- Conditions
- Spinal Stenosis
- Being tested
- No intervention
- Keywords
- Exercise test, Spinal stenosis, Physical fitness
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
2-minute step test
The patient was instructed to lift their knees to the minimum marked level and take as many steps as possible in place for a duration of two minutes.
Measured: Baseline and Day 7
Secondary outcomes (4)
6-minute walk test
The distance the patient walked for six minutes was measured.
Measured: Baseline and Day 7
2-minute walk test
The distance the patient walked for two minutes was measured.
Measured: Baseline and Day 7
Oswestry Disability Index
This is a patient-reported outcome measure used by clinicians and researchers to quantify disability related to low back pain: Higher scores indicate worse functional status.
Measured: Baseline and Day 7
Visual Analogue Scale
Pain score; higher scores indicate higher pain levels.
Measured: Baseline and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Sep 2023
- Primary completion30 Oct 2023
- Study completion31 Oct 2023
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 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nur Kesiktas, MD, Study chair, İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060821
- Sponsor's protocol ID
- IstPRMTRH1
- Status last verified
- Feb 2024
- First submitted
- 24 Sep 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paker N, Sirin Ahisha B, Kesiktas N, Bugdayci ND, Soluk Ozdemir Y. Construct validity and reliability of the 2-minute step test in patients with lumbar spinal stenosis. Disabil Rehabil. 2025 Jul;47(14):3708-3713. doi: 10.1080/09638288.2024.2428824. Epub 2024 Nov 19.
PubMed 39563102
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construct Validity and Reliability of the 2-minute Step Test in Patients With Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT06060821
- Acronym / sponsor ID
- IstPRMTRH1
- Conditions
- Spinal Stenosis
- Keywords
- Exercise test, Spinal stenosis, Physical fitness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 29 Sep 2023 (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 was to investigate the validity and reliability of the 2 Minute Step Test (2MST) in patients with symptomatic degenerative lumbar spinal stenosis and to explore its correlation with objective assessment methods, namely the 2 Minute Walk Test (2MWT) and the 6 Minute Walk Test (6MWT).
Detailed description
This cross-sectional study will include 55 volunteers aged 18-80 years who present to the Istanbul Physical Medicine and Rehabilitation Training and Research Hospital outpatient clinics and are diagnosed with Lumbar Spinal Stenosis (LSS) through MRI. The demographic characteristics of the patients will be recorded, and their walking distances will be inquired about. The severity of the disease will be determined by examining the levels of stenosis on lumbar MRI scans. All patients will be initially assessed using the 2MST (2-Minute Step Test), 2MWT (2-Minute Walk Test), 6MWT (6-Minute Walk Test), VAS (Visual Analogue Scale), and ODI (Oswestry Disability Index). To measure test-retest reliability, the 2MST will be administered again with a 7-day interval between assessments.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-80 who have been diagnosed with lumbar spinal stenosis based on magnetic resonance images.
Key inclusion criteria (1 listed)
- Patients aged 18-80 who have been diagnosed with lumbar spinal stenosis based on magnetic resonance images.
Key exclusion criteria (9 listed)
- Uncontrolled hypertension
- Decompensated heart failure
- Presence of systemic diseases affecting lower extremity functions
- Presence of degenerative diseases affecting lower extremity functions
- Peripheral artery disease causing vascular claudication
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 |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
2-minute step test
Time frame: Baseline and Day 7
The patient was instructed to lift their knees to the minimum marked level and take as many steps as possible in place for a duration of two minutes.
4 secondary outcomes
6-minute walk test
Time frame: Baseline and Day 7
2-minute walk test
Time frame: Baseline and Day 7
Oswestry Disability Index
Time frame: Baseline and Day 7
Visual Analogue Scale
Time frame: Baseline and Day 7
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 20 Feb 2024.
- Derived from this study: PubMed 39563102Paker N, Sirin Ahisha B, Kesiktas N, Bugdayci ND, Soluk Ozdemir Y. Construct validity and reliability of the 2-minute step test in patients with lumbar spinal stenosis. Disabil Rehabil. 2025 Jul;47(14):3708-3713. doi: 10.1080/09638288.2024.2428824. Epub 2024 Nov 19.
- 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.
Nur Kesiktas, MD study chair
İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
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 Spinal Stenosis, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 1 inclusion and 9 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 20 Feb 2024. 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?
2-minute step test (time frame: Baseline and Day 7). 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 NCT06060821, 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 20 Feb 2024.