Multiple Sclerosis
Conditions
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.
Interventions
DIAGNOSTIC_TESTThe 6-minutes Walk Test
To walk for 6 minutes
Sponsors
Haute Ecole de Santé Vaud
University of Applied Sciences of Western Switzerland
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The 6-minutes Walk Test on 6 Meters | First test day | The patient walk for 6 minutes back and forth in a 6-meter hallway turning around cones. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 360 Degree Turn Test (Time) | First test day | The person must complete a full lap on himself or herself and the execution time is measured |
| 360 Degree Turn Test (Number of Steps) | First test day | The person must complete a full lap on himself or herself and the number of steps is measured |
| 6 Minute Walk Test on 30 Meters | Second test day | The patient walk for 6 minutes back and forth in a 30-meter hallway turning around cones. |
| The 6-minutes Walk Test on 6 Meters | Second test day | The patient walk for 6 minutes back and forth in a 6-meter hallway turning around cones. |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORKenny Guex, PhD
Haute Ecole de Santé Vaud
Participant flow
Pre-assignment details
On 32 patients pre-screened, 4 could not be reached by phone, 1 left for another country, 1 suffered too much from heath, 4 did not met inclusion criteria and 1 finally withdrew : 21 were enrolled
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 10.6 |
| Assistive device 1 crutch | 2 Participants |
| Assistive device 2 crutches | 1 Participants |
| Assistive device 2 walking sticks | 4 Participants |
| Assistive device None | 9 Participants |
| Assistive device Walker | 5 Participants |
| Disease duration | 19 years |
| Expanded Disability Status Scale | 4.75 units on a scale |
| Height | 168 cm STANDARD_DEVIATION 5.6 |
| Medication Fingolimod | 1 Participants |
| Medication Interferon | 2 Participants |
| Medication None | 10 Participants |
| Medication Ocrelizumab | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment Switzerland | 21 participants |
| Regular physical activity | 90 min |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 4 Participants |
| Time since last relapse | 60 month |
| Type of MS Primary progressive | 1 Participants |
| Type of MS Relapsing-remitting | 10 Participants |
| Type of MS Secondary progressive | 10 Participants |
| Visual Analogue Scale for Fatigue | 2 units on a scale |
| Weight | 64 kg STANDARD_DEVIATION 10 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
None listed