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

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
2-minute walk test
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schweizer Paraplegiker-Zentrum
  • Balgrist University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with spinal cord injuries

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Inertia Measuring Unit data

Full Information

First Posted
August 26, 2020
Last Updated
July 17, 2023
Sponsor
University of Zurich
Collaborators
Swiss Paraplegic Research, Nottwil
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1. Study Identification

Unique Protocol Identification Number
NCT04555759
Brief Title
Validity and Reliability of the 2-minute Walk Test in Individuals With a Spinal Cord Injury
Official Title
Validity and Reliability of the 2-minute Walk Test in Individuals With a Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
June 21, 2021 (Actual)
Study Completion Date
June 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Swiss Paraplegic Research, Nottwil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient with spinal cord injuries
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
2-minute walk test
Intervention Description
The patients will do a 2-minute walk test, using their walking aids or braces
Primary Outcome Measure Information:
Title
2-minute walk test (meters an individual walks in 2 minutes)
Time Frame
1-7 days
Secondary Outcome Measure Information:
Title
Inertia Measuring Unit data
Time Frame
1-7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armin Curt, Prof.
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schweizer Paraplegiker-Zentrum
City
Nottwil
ZIP/Postal Code
6207
Country
Switzerland
Facility Name
Balgrist University Hospital
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
35999254
Citation
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.
Results Reference
derived

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

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