NCT04228328

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 3, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2020

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

February 4, 2026

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

January 10, 2020

Results QC Date

July 14, 2021

Last Update Submit

February 3, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    First test day

Secondary Outcomes (4)

  • 360 Degree Turn Test (Time)

    First test day

  • 360 Degree Turn Test (Number of Steps)

    First test day

  • 6 Minute Walk Test on 30 Meters

    Second test day

  • The 6-minutes Walk Test on 6 Meters

    Second test day

Interventions

To walk for 6 minutes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Multiple sclerosis patient able to walk at least 30 meters, Expanded Disability Status Scale from 3 to 6.5

You may qualify if:

  • 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

You may not qualify if:

  • Lung disease
  • Heart disease
  • co-morbidity preventing 6minWT
  • relapse in the last 3 months
  • chronic fatigue ≥ at 8 (Visual Analog Scale- Fatigue)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haute Ecole de Santé Vaud

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Walk Test

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Exercise TestHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Pr Kenny Guex, director of thesis
Organization
Haute Ecole de Santé Vaud

Study Officials

  • Kenny Guex, PhD

    Haute Ecole de Santé Vaud

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2020

First Posted

January 14, 2020

Study Start

March 3, 2020

Primary Completion

November 5, 2020

Study Completion

November 5, 2020

Last Updated

February 4, 2026

Results First Posted

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations