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

NCT04555759 | Completed

• 1 other identifier: 2020-01473
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

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

  1-7 days

Secondary Outcomes (1)

• Inertia Measuring Unit data

  1-7 days

Study Arms (1)

Patient with spinal cord injuries

EXPERIMENTAL

Other: 2-minute walk test

Interventions

2-minute walk test OTHER

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

Patient with spinal cord injuries

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Swiss Paraplegic Research, Nottwil: collaborator

Study Sites (2)

Schweizer Paraplegiker-Zentrum

Nottwil, 6207, Switzerland

Location

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

Related Publications (2)

• Willi R, Werner C, Demko L, de Bie R, Filli L, Zorner B, Curt A, Bolliger M. Reliability of patient-specific gait profiles with inertial measurement units during the 2-min walk test in incomplete spinal cord injury. Sci Rep. 2024 Feb 6;14(1):3049. doi: 10.1038/s41598-024-53301-y.

  PMID: 38321085 DERIVED

• 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.

  PMID: 35999254 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Armin Curt, Prof.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 21, 2020
• Study Start: January 16, 2020
• Primary Completion: June 21, 2021
• Study Completion: June 21, 2021
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

CH (2)