Clinical trial NCT04228328: Validity and Reliability of the 6-minute Walk Test Over a Distance of 6 Metres in People With Multiple Sclerosis
Official title: Validity and Reliability of the 6-minute Walk Test Over a Distance of 6 Metres in People With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Haute Ecole de Santé Vaud
Sponsor class: OTHER
Collaborators: name: University of Applied Sciences of Western Switzerland
First posted: 2020-01-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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

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).

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.

Eligibility 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)

Primary outcomes:
measure: The 6- minutes Walk Test
timeFrame: 6 minutes
Secondary outcomes:
measure: 360 Degree Turn Test
timeFrame: max 10 seconds
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Haute Ecole de Santé Vaud
state: VD
Study officials:
affiliation: Haute Ecole de Santé Vaud
name: Kenny Guex, PhD
role: PRINCIPAL_INVESTIGATOR
References: