NCT06060821

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

September 24, 2023

Last Update Submit

February 18, 2024

Conditions

Keywords

Exercise testSpinal stenosisPhysical fitness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 6-minute walk test

    Baseline and Day 7

  • 2-minute walk test

    Baseline and Day 7

  • Oswestry Disability Index

    Baseline and Day 7

  • Visual Analogue Scale

    Baseline and Day 7

Interventions

No intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Nur Kesiktas, MD

    İstanbul Physical Therapy Rehabilitation Training & Research Hosptial

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Week
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2023

First Posted

September 29, 2023

Study Start

September 1, 2023

Primary Completion

October 30, 2023

Study Completion

October 31, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations