Validity and Reliability of the 2-minute Step Test in Patients With Lumbar Spinal Stenosis

February 18, 2024 updated by: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients aged 18-80 who have been diagnosed with lumbar spinal stenosis based on magnetic resonance images.

Description

Inclusion Criteria:

  • Patients aged 18-80 who have been diagnosed with lumbar spinal stenosis based on magnetic resonance images.

Exclusion Criteria:

  • 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
  • Neuromuscular disease
  • Pregnancy
  • Cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-minute walk test
Time Frame: Baseline and Day 7
The distance the patient walked for six minutes was measured.
Baseline and Day 7
2-minute walk test
Time Frame: Baseline and Day 7
The distance the patient walked for two minutes was measured.
Baseline and Day 7
Oswestry Disability Index
Time Frame: Baseline and Day 7
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.
Baseline and Day 7
Visual Analogue Scale
Time Frame: Baseline and Day 7
Pain score; higher scores indicate higher pain levels.
Baseline and Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

  • Study Chair: Nur Kesiktas, MD, İstanbul Physical Therapy Rehabilitation Training & Research Hosptial

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

October 30, 2023

Study Completion (Actual)

October 31, 2023

Study Registration Dates

First Submitted

September 24, 2023

First Submitted That Met QC Criteria

September 24, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstPRMTRH1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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