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

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT04228328
• Lead Sponsor: Haute Ecole de Santé Vaud

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.

Study Timeline

• Study First Submitted: 2020-01-10
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-14
• Study Start: 2020-03-03
• Primary Completion: 2020-11-05
• Study Completion: 2020-11-05
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The 6- minutes Walk Test	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

Name	Time	Method
360 Degree Turn Test	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

Trial Locations

Locations (1)

Haute Ecole de Santé Vaud; 🇨🇭 Lausanne, VD, Switzerland