Multiple SclerosisVR6minWT6NCT04228328
Validity and Reliability of the 6-minute Walk Test Over a Distance of 6 Metres in People With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Haute Ecole de Santé Vaud at 1 site in Switzerland.
Trial summary
The objective of this study is to validate a different version of the 6 minutes Walk Test (6minWT), the 6minWT on 6 meters, instead of the 30 meters. The secondary objectives are to verify the reliability of this new version and to analyze the possible differences between the 6minWT6 and the 6minWT30 (according to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- The 6-minutes Walk Test
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Mar 2020to 5 Nov 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Multiple sclerosis patient able to walk at least 30 meters, Expanded Disability Status Scale from 3 to 6.5
Who may be able to join
- adults
- confirmed diagnosis of MS
- Expanded Disability Status Scale score 3 to 6.5 or to be able to walk 30 meters with or without aids
- good understanding of French
- have already completed a 6-minute walk test
- to be able to give consent by signature
Who cannot join
- Lung disease
- Heart disease
- co-morbidity preventing 6minWT
- relapse in the last 3 months
- chronic fatigue ≥ at 8 (Visual Analog Scale- Fatigue)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Haute Ecole de Santé Vaud
Lausanne, Canton of Vaud, 1011
About this study
The objective of this study is to validate a different version of the 6 minutes Walk Test (6minWT), the 6minWT on 6 meters, instead of the 30 meters.
The secondary objectives are to verify the reliability of this new version and to analyze the possible differences between the 6minWT6 and the 6minWT30 (according to speed at half-turn, other parameters: age, gender, height, EDSS score, type of disease, time since relapse).
Read the detailed description
The 6minWT is used by physiotherapists to monitor the walking endurance abilities of multiple sclerosis (MS) patients. The protocol for this test recommends a distance of 30 meters (6minWT30) to perform the test. However, this distance is not always available in practices and patients' homes. The aim of this study is therefore to validate a protocol over a distance of 6 meters (6minWT6) and to evaluate its reliability : intra-evaluator and test-retest.
The project focuses on the population of walking patients with MS. Inclusion: adults, confirmed diagnosis of MS, Expanded Disability Status Scale (EDSS) score 3 to 6.5, or be able to walk 30 metres with or without aids, good understanding of French, have already completed a 6-minute walking test, be able to give consent by signature.
Exclusion: Lung disease, heart disease, co-morbidity preventing 6minWT, relapse in the last 3 months, chronic fatigue ≥ at 8 (Visual Analog Score-Fatigue or Rochester Fatigue Diary).
21 participants will be needed to obtain a good correlation coefficient, which is the objective of the validation of the new version of the 6minWT. The alpha was set at 0.01, the power at 0.9 for a correlation of 0.8.
Each patient will enter the study for one week, corresponding to two visits. The participant will perform the 6minWT6 and the 360 Degree Turn Test the first day and the 6minWT30 followed by the 6minWT6 after up to 45 minutes rest, the second day, a week apart.
- Conditions
- Multiple Sclerosis
- Being tested
- The 6-minutes Walk Test
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The 6-minutes Walk TestDiagnostic test
To walk for 6 minutes
What is being measured
The primary outcome is the main question the study is designed to answer.
The 6-minutes Walk Test on 6 Meters
The patient walk for 6 minutes back and forth in a 6-meter hallway turning around cones.
Measured: First test day
Secondary outcomes (4)
360 Degree Turn Test (Time)
The person must complete a full lap on himself or herself and the execution time is measured
Measured: First test day
360 Degree Turn Test (Number of Steps)
The person must complete a full lap on himself or herself and the number of steps is measured
Measured: First test day
6 Minute Walk Test on 30 Meters
The patient walk for 6 minutes back and forth in a 30-meter hallway turning around cones.
Measured: Second test day
The 6-minutes Walk Test on 6 Meters
The patient walk for 6 minutes back and forth in a 6-meter hallway turning around cones.
Measured: Second test day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start3 Mar 2020
- Primary completion5 Nov 2020
- Study completion5 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haute Ecole de Santé Vaud
- Sponsor type
- University, hospital or other
- Collaborators
- University of Applied Sciences of Western Switzerland
- Responsible party
- Sponsor
- Investigators
- Kenny Guex, PhD, Principal investigator, Haute Ecole de Santé Vaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228328
- Sponsor's protocol ID
- 2019-01864
- Other IDs
- 2019
- Acronym
- VR6minWT6
- Status last verified
- Feb 2026
- First submitted
- 10 Jan 2020
- Last updated
- 4 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the 6-minute Walk Test Over a Distance of 6 Metres in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04228328
- Acronym / sponsor ID
- VR6minWT6 / 2019-01864
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Haute Ecole de Santé VaudUniversity, hospital or other
- Collaborators
- University of Applied Sciences of Western Switzerland
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 14 Jan 2020 (actual)
- Results
- Posted 4 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to validate a different version of the 6 minutes Walk Test (6minWT), the 6minWT on 6 meters, instead of the 30 meters.
The secondary objectives are to verify the reliability of this new version and to analyze the possible differences between the 6minWT6 and the 6minWT30 (according to speed at half-turn, other parameters: age, gender, height, EDSS score, type of disease, time since relapse).
Detailed description
The 6minWT is used by physiotherapists to monitor the walking endurance abilities of multiple sclerosis (MS) patients. The protocol for this test recommends a distance of 30 meters (6minWT30) to perform the test. However, this distance is not always available in practices and patients' homes. The aim of this study is therefore to validate a protocol over a distance of 6 meters (6minWT6) and to evaluate its reliability : intra-evaluator and test-retest.
The project focuses on the population of walking patients with MS. Inclusion: adults, confirmed diagnosis of MS, Expanded Disability Status Scale (EDSS) score 3 to 6.5, or be able to walk 30 metres with or without aids, good understanding of French, have already completed a 6-minute walking test, be able to give consent by signature.
Exclusion: Lung disease, heart disease, co-morbidity preventing 6minWT, relapse in the last 3 months, chronic fatigue ≥ at 8 (Visual Analog Score-Fatigue or Rochester Fatigue Diary).
21 participants will be needed to obtain a good correlation coefficient, which is the objective of the validation of the new version of the 6minWT. The alpha was set at 0.01, the power at 0.9 for a correlation of 0.8.
Each patient will enter the study for one week, corresponding to two visits. The participant will perform the 6minWT6 and the 360 Degree Turn Test the first day and the 6minWT30 followed by the 6minWT6 after up to 45 minutes rest, the second day, a week apart.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple sclerosis patient able to walk at least 30 meters, Expanded Disability Status Scale from 3 to 6.5
Key inclusion criteria (6 listed)
- adults
- confirmed diagnosis of MS
- Expanded Disability Status Scale score 3 to 6.5 or to be able to walk 30 meters with or without aids
- good understanding of French
- have already completed a 6-minute walk test
Key exclusion criteria (5 listed)
- Lung disease
- Heart disease
- co-morbidity preventing 6minWT
- relapse in the last 3 months
- chronic fatigue ≥ at 8 (Visual Analog Scale- Fatigue)
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 |
|---|---|---|
| The 6-minutes Walk TestTo walk for 6 minutes | Diagnostic test | – |
Primary outcome
The 6-minutes Walk Test on 6 Meters
Time frame: First test day
The patient walk for 6 minutes back and forth in a 6-meter hallway turning around cones.
4 secondary outcomes
360 Degree Turn Test (Time)
Time frame: First test day
360 Degree Turn Test (Number of Steps)
Time frame: First test day
6 Minute Walk Test on 30 Meters
Time frame: Second test day
The 6-minutes Walk Test on 6 Meters
Time frame: Second test day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kenny Guex, PhD principal investigator
Haute Ecole de Santé Vaud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Haute Ecole de Santé Vaud at 1 site 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 6 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 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 4 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The 6-minutes Walk Test on 6 Meters (time frame: First test day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2026.