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CompletedNCT04555759Updated Jul 18, 2023

Validity and Reliability of the 2-minute Walk Test in Individuals With a Spinal Cord Injury

An interventional study of 2-minute walk test in Spinal Cord Injuries, sponsored by University of Zurich. Completed at 2 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-18.

Sponsored by University of Zurich · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jan 2020, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

There exist a variety of outcome measures to asses gait function in individuals with a spinal cord injury (SCI). The most established measures are the 10-meter walk test (10MWT) and the 6-minute walk test (6mWT). They are used to assess treatment efficacy and recovery of gait function in individuals with SCI. However, the 10MWT is appropriate for poor walkers but not sensitive in good walkers and the 6mWT can be time-consuming and is very demanding for severely impaired patients. Therefore the 2-minute walk test (2mWT) has gained more attention in the SCI field. The 2mWT has been established in numerous neurological diseases and has shown to correlate with the 6mWT in patients with neuromuscular disease, multiple sclerosis and stroke. Though the 2mWT has not yet been validated in individuals with SCI.

A limitation that affects all timed walking tests is that they suffer from limited information about gait quality (i.e. how walking function is achieved). Being able to receive information on the gait quality of a patient can help to understand the underlying mechanisms of walking improvements after an intervention (e.g. compensation vs recovery). The research in the field of inertia measuring units (IMU) develops and advances very rapidly at the moment resulting in the possibility to perform a gait analysis with a simple IMU setup. However, the reliability of such measurement setups has not yet been shown in individuals with SCI.

The primary aim of this study is to test the validity and reliability of the 2mWT in the SCI population.

Additionally, it will be investigated if a simple sensor setup can give additional reliable information about the gait pattern of individuals with SCI.

02

Conditions studied

  • Spinal Cord Injuries
03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's enrollment of 50 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participants fulfilling all of the following inclusion criteria are eligible for the study:
  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • At least 18 years old
  • Spinal cord injury
  • Able to walk with a speed of at least 0.17m/s with or without walking devices and or bracing

Exclusion criteria

Exclusion Criteria:

  • Current orthopaedic problems of lower limbs
  • History of severe cardiac condition
  • Premorbid major depression or psychosis
  • Unlikely to complete the intervention or return for second visit
  • Enrolment of the investigator, his/her family members, employees and other dependent persons
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Patient with spinal cord injuries

    Other: 2-minute walk test

Interventions

  • Other2-minute walk test

    The patients will do a 2-minute walk test, using their walking aids or braces

06

What researchers measure

Primary outcomes

  1. 2-minute walk test (meters an individual walks in 2 minutes)

    Time frame: 1-7 days

Secondary outcomes

  1. Inertia Measuring Unit data

    Time frame: 1-7 days

07

Study locations

2 sites
  • Schweizer Paraplegiker-Zentrum
    Nottwil, 6207, Switzerland
  • Balgrist University Hospital
    Zurich, 8008, Switzerland
08

References and documents

Publications

  • Willi R, Widmer M, Merz N, Bastiaenen CHG, Zorner B, Bolliger M. Validity and reliability of the 2-minute walk test in individuals with spinal cord injury. Spinal Cord. 2023 Jan;61(1):15-21. doi: 10.1038/s41393-022-00847-1. Epub 2022 Aug 23. PubMed 35999254 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04555759
Lead sponsor
University of Zurich
Collaborators
Swiss Paraplegic Research, Nottwil
Responsible party
Sponsor
First posted
Sep 21, 2020
Start date
Jan 16, 2020
Primary completion
Jun 21, 2021
Completion
Jun 21, 2021
Last update
Jul 18, 2023

Study contacts

Armin Curt, Prof.
principal investigator · University of Zurich

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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