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

Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06060821
• Other study ID #: IstPRMTRH1
• Status: Completed
• Start date: September 1, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2024
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 31, 2023
• Est. primary completion date: October 30, 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Turkey	Istanbul Physical Medicine Rehabilitation Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Day 7
Secondary	6-minute walk test	The distance the patient walked for six minutes was measured.	Baseline and Day 7
Secondary	2-minute walk test	The distance the patient walked for two minutes was measured.	Baseline and Day 7
Secondary	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.	Baseline and Day 7
Secondary	Visual Analogue Scale	Pain score; higher scores indicate higher pain levels.	Baseline and Day 7