Validity and Reliability of the 2-minute Walk Test in Ind... | NCT04555759

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

NCT04555759

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Jul 18, 2023Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Spinal Cord Injuries

Interventions

2-minute walk test

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 16, 2020Actual

Primary Completion Date

Jun 21, 2021Actual

Completion Date

Jun 21, 2021Actual

First Submitted Date

Aug 26, 2020

First Submission Date that Met QC Criteria

Sep 17, 2020

First Posted Date

Sep 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2023

Last Update Posted Date

Jul 18, 2023Actual

Name	Class
Swiss Paraplegic Research, Nottwil	NETWORK

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient with spinal cord injuries	Experimental		Other: 2-minute walk test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
2-minute walk test (meters an individual walks in 2 minutes)		1-7 days

Secondary Outcomes

Measure	Description	Time Frame
Inertia Measuring Unit data		1-7 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Armin Curt, Prof.	University of Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schweizer Paraplegiker-Zentrum		Nottwil		6207	Switzerland
Balgrist University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38321085	Derived	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.
35999254	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.

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System