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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04555759
• Other study ID #: 2020-01473
• Status: Completed
• Phase: N/A
• Start date: January 16, 2020
• Est. completion date: June 21, 2021

Study information

• Verified date: July 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 21, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Switzerland	Schweizer Paraplegiker-Zentrum	Nottwil
Switzerland	Balgrist University Hospital	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Swiss Paraplegic Research

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-minute walk test (meters an individual walks in 2 minutes)		1-7 days
Secondary	Inertia Measuring Unit data		1-7 days