Validity and Reliability of the 6-minute Walk Test Over a Distance of 6 Metres in People With Multiple Sclerosis
NCT ID: NCT04228328
Last Updated: 2020-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
21 participants
OBSERVATIONAL
2020-03-03
2020-11-05
Brief Summary
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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
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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
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Study Design
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OTHER
CROSS_SECTIONAL
Interventions
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The 6-minutes Walk Test
To walk for 6 minutes
Eligibility Criteria
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Inclusion Criteria
* confirmed diagnosis of MS
* Expanded Disability Status Scale score 3 to 6.5
* 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
* Heart disease
* co-morbidity preventing 6minWT
* relapse in the last 3 months
* chronic fatigue ≥ at 8 (Visual Analog Scale- Fatigue)
18 Years
ALL
No
Sponsors
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University of Applied Sciences of Western Switzerland
OTHER
Haute Ecole de Santé Vaud
OTHER
Responsible Party
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Principal Investigators
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Kenny Guex, PhD
Role: PRINCIPAL_INVESTIGATOR
Haute Ecole de Santé Vaud
Locations
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Haute Ecole de Santé Vaud
Lausanne, Canton of Vaud, Switzerland
Countries
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Other Identifiers
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2019-01864
Identifier Type: -
Identifier Source: org_study_id