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

• Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06060821
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Anticipated Duration (Months): 2
• Patients Per Site Per Month: 27.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Spinal Stenosis	Other: No intervention

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

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 55 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Construct Validity and Reliability of the 2-minute Step Test in Patients With Lumbar Spinal Stenosis
• Actual Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Oct 30, 2023
• Anticipated Study Completion Date: Oct 31, 2023

Outcome Measures

Primary Outcome Measures

1. 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

1. 6-minute walk test [Baseline]

   The distance the patient walked for six minutes was measured.

2. 2-minute walk test [Baseline]

   The distance the patient walked for two minutes was measured.

3. Oswestry Disability Index [Baseline]

   Oswestry Disability Index

4. Visual Analogue Scale [Baseline]

   pain score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Physical Medicine Rehabilitation Training and Research Hospital	Istanbul		Turkey

Sponsors and Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT06060821
• Other Study ID Numbers: IstPRMTRH1
• First Posted: Sep 29, 2023
• Last Update Posted: Sep 29, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Istanbul Physical Medicine Rehabilitation Training and Research Hospital: Exercise test; Spinal stenosis; Physical fitness
• Additional relevant MeSH terms: Spinal Stenosis; Constriction, Pathologic

Study Results

No Results Posted as of Sep 29, 2023