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

Completed

• Conditions: Spinal Stenosis

• Registration Number: NCT06060821
• Lead Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Brief 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).

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 Timeline

• Study Start: 2023-09-01
• Study First Submitted: 2023-09-24
• Study First Submitted QC: 2023-09-24
• Study First Posted: 2023-09-29
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-18
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2-minute step test	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital; 🇹🇷 Istanbul, Turkey