Spinal Cord InjuriesNCT04555759
Validity and Reliability of the 2-minute Walk Test in Individuals With a Spinal Cord Injury
A study testing 2-minute walk test in people with Spinal Cord Injuries, run by University of Zurich at 2 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- 2-minute walk test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 16 Jan 2020to 21 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Schweizer Paraplegiker-Zentrum
Nottwil, 6207
Balgrist University Hospital
Zurich, 8008
About this study
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.
Read more
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
- Being tested
- 2-minute walk test
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-minute walk testOther
The patients will do a 2-minute walk test, using their walking aids or braces
| Study group | Role | What they receive |
|---|---|---|
| Patient with spinal cord injuries | Experimental | Not described Receives: Other: 2-minute walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-minute walk test (meters an individual walks in 2 minutes)
Measured: 1-7 days
Secondary outcomes (1)
Inertia Measuring Unit data
Measured: 1-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start16 Jan 2020
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Paraplegic Research, Nottwil
- Responsible party
- Sponsor
- Investigators
- Armin Curt, Prof., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555759
- Sponsor's protocol ID
- 2020-01473
- Status last verified
- Jul 2023
- First submitted
- 26 Aug 2020
- Last updated
- 18 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38321085Willi 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.
PubMed 35999254
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the 2-minute Walk Test in Individuals With a Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04555759
- Acronym / sponsor ID
- 2020-01473
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss Paraplegic Research, Nottwil
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with spinal cord injuries | Experimental | Other: 2-minute walk test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-minute walk testThe patients will do a 2-minute walk test, using their walking aids or braces | Other | Patient with spinal cord injuries |
Primary outcome
2-minute walk test (meters an individual walks in 2 minutes)
Time frame: 1-7 days
1 secondary outcome
Inertia Measuring Unit data
Time frame: 1-7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Derived from this study: PubMed 38321085Willi 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.
- Derived from this study: PubMed 35999254Willi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armin Curt, Prof. principal investigator
University of Zurich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-minute walk test in people with Spinal Cord Injuries, run by University of Zurich at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-minute walk test (meters an individual walks in 2 minutes) (time frame: 1-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04555759, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.