Examining walking fatigue and brain activity in people with multiple sclerosis
Gait and Cortical Activity Profile of People with Multiple Sclerosis Presenting with Walking Fatigability
This study is testing how walking fatigue affects people with multiple sclerosis and how it relates to their brain activity compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hasselt University Academic / other |
| Locations | 3 sites (Diepenbeek, Limburg and 2 other locations) |
| Trial ID | NCT06672484 on ClinicalTrials.gov |
What this trial studies
This observational study investigates walking fatigability in individuals with multiple sclerosis (pwMS) by assessing their walking distance and gait quality over a 6-minute walking test. It aims to understand how brain activity correlates with motor impairments related to walking fatigue. The study will include 70 pwMS and 30 healthy controls, with participants undergoing clinical assessments and completing questionnaires related to their condition. The research will be conducted over three days, focusing on both observational and feasibility aspects of walking fatigability.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 65 with a diagnosis of multiple sclerosis and specific levels of disability as defined by the Expanded Disability Status Scale (EDSS).
Not a fit: Patients with cognitive impairments, those requiring assistive devices for walking, or with significant musculoskeletal disorders unrelated to MS may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of walking fatigue in patients with multiple sclerosis.
How similar studies have performed: While this study explores a specific aspect of walking fatigability, similar observational studies have shown promise in understanding motor impairments in multiple sclerosis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (part A and B): * age between 18 and 65 years old * a diagnosis of MS (2017 revisions of the McDonalds criteria) with EDSS 1 up to 6.5 (part A) and with EDSS 1 up to 5.5 (part B) OR minimal punctuation of 2 in the MSWS-12 for one of the items: 7, 10, 11, and 12 (for pwMS) * no relapses 1 month preceding the start of the study (for pwMS) * ability to walk for 6 minutes without rest Exclusion Criteria (Part A and B): * Cognitive impairment hindering understanding of study instructions, * Pregnancy * Musculoskeletal disorders in the lower limbs that are not related to MS. * PwMS needing an assistive device to walk can not be included in part B given safety reasons.
Where this trial is running
Diepenbeek, Limburg and 2 other locations
- University of Hasselt — Diepenbeek, Limburg, Belgium (Recruiting)
- National MS Melsbroek — Melsbroek, Belgium (Recruiting)
- Noorderhart Rehabilitation & MS centre — Overpelt, Belgium (Recruiting)
Study contacts
- Study coordinator: Felipe B Santinelli PhD student, MSc
- Email: felipe.balistierisantinelli@uhasselt.be
- Phone: 3211268825
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.