- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04228328
Validity and Reliability of the 6-minute Walk Test Over a Distance of 6 Metres in People With Multiple Sclerosis (VR6minWT6)
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).
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Canton of Vaud
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Lausanne, Canton of Vaud, Switzerland, 1011
- Haute Ecole de Santé Vaud
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Lung disease
- Heart disease
- co-morbidity preventing 6minWT
- relapse in the last 3 months
- chronic fatigue ≥ at 8 (Visual Analog Scale- Fatigue)
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
First test day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
360 Degree Turn Test (Time)
Time Frame: First test day
|
The person must complete a full lap on himself or herself and the execution time is measured
|
First test day
|
|
360 Degree Turn Test (Number of Steps)
Time Frame: First test day
|
The person must complete a full lap on himself or herself and the number of steps is measured
|
First test day
|
|
6 Minute Walk Test on 30 Meters
Time Frame: Second test day
|
The patient walk for 6 minutes back and forth in a 30-meter hallway turning around cones.
|
Second test day
|
|
The 6-minutes Walk Test on 6 Meters
Time Frame: Second test day
|
The patient walk for 6 minutes back and forth in a 6-meter hallway turning around cones.
|
Second test day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kenny Guex, PhD, Haute Ecole de Santé Vaud
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Autoimmune Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Multiple Sclerosis
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Techniques, Cardiovascular
- Heart Function Tests
- Exercise Test
- Walk Test
Other Study ID Numbers
- 2019-01864
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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