NCT04555759

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

Completed NA Last updated 18 July 2023

What this trial tests

NA trial testing 2-minute walk test in Spinal Cord Injuries in 50 participants. Completed in 21 June 2021.

Timeline

16 January 2020

Primary endpoint
21 June 2021

21 June 2021

Quick facts

Lead sponsor	University of Zurich
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	50
Start date	16 January 2020
Primary completion	21 June 2021
Estimated completion	21 June 2021
Sites	2 locations across Switzerland

Drugs / interventions tested

• 2-minute walk test

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →

Sponsor

University of Zurich

Who can join

18 and older, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Validity and reliability of the 2-minute walk test in individuals with spinal cord injury.
   Willi R, Widmer M, Merz N, Bastiaenen CHG, et al · · 2023 · cited 11× · PMID 35999254 · DOI 10.1038/s41393-022-00847-1
2. Reliability of patient-specific gait profiles with inertial measurement units during the 2-min walk test in incomplete spinal cord injury.
   Willi R, Werner C, Demkó L, de Bie R, et al · · 2024 · cited 6× · PMID 38321085 · DOI 10.1038/s41598-024-53301-y