Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-26 @ 12:48 AM
Study NCT ID:
NCT04555759
Status:
COMPLETED
Last Update Posted:
2023-07-18
First Post:
2020-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity and Reliability of the 2-minute Walk Test in Individuals With a Spinal Cord Injury
Sponsor:
University of Zurich
Organization:
Study Overview
Official Title:
Validity and Reliability of the 2-minute Walk Test in Individuals With a Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: