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Completed

NCT Number: NCT04228328

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haute Ecole de Santé Vaud

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

The 6-minutes Walk Test

Diagnostic Test

To walk for 6 minutes

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Haute Ecole de Santé Vaud

Other

Collaborators

  • University of Applied Sciences of Western Switzerland

Registry information

Acronym: VR6minWT6

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 14, 2020
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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