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Validity and Reliability of the 6-minute Walk Test Over a Distance of 6 Metres in People With Multiple Sclerosis (VR6minWT6)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04228328
Recruitment Status : Completed
First Posted : January 14, 2020
Last Update Posted : December 21, 2020
Sponsor:
Collaborator:
University of Applied Sciences of Western Switzerland
Information provided by (Responsible Party):
Haute Ecole de Santé Vaud

Study Description
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Brief 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 speed at half-turn, other parameters: age, gender, height, EDSS score, type of disease, time since relapse).


Condition or disease Intervention/treatment
Multiple Sclerosis Diagnostic Test: The 6-minutes Walk Test

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
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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Validity and Reliability of the 6-minute Walk Test Over a Distance of 6 Metres in People With Multiple Sclerosis
Actual Study Start Date : March 3, 2020
Actual Primary Completion Date : November 5, 2020
Actual Study Completion Date : November 5, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: The 6-minutes Walk Test
    To walk for 6 minutes

Outcome Measures
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Primary Outcome Measures :
  1. The 6- minutes Walk Test [ Time Frame: 6 minutes ]
    Distance in meters covered by a person to walk, at his or her own pace, without talking and running in 6 minutes, on a 6-metre and 30-meter-course


Secondary Outcome Measures :
  1. 360 Degree Turn Test [ Time Frame: max 10 seconds ]
    The person must complete a full lap on himself or herself and the execution time and the number of steps are measured


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Multiple sclerosis patient able to walk at least 30 meters, Expanded Disability Status Scale from 3 to 6.5
Criteria

Inclusion Criteria:

  • adults
  • 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:

  • Lung disease
  • Heart disease
  • co-morbidity preventing 6minWT
  • relapse in the last 3 months
  • chronic fatigue ≥ at 8 (Visual Analog Scale- Fatigue)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04228328


Locations
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Switzerland
Haute Ecole de Santé Vaud
Lausanne, VD, Switzerland, 1011
Sponsors and Collaborators
Haute Ecole de Santé Vaud
University of Applied Sciences of Western Switzerland
Investigators
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Principal Investigator: Kenny Guex, PhD Haute Ecole de Santé Vaud
More Information
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Responsible Party: Haute Ecole de Santé Vaud
ClinicalTrials.gov Identifier: NCT04228328    
Other Study ID Numbers: 2019-01864
First Posted: January 14, 2020    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases