NCT05412043Completed
Fatigability in Persons With Multiple Sclerosis: Inputs From Cognition, Walking and Coordination
Walking-related Fatigability in Persons With Multiple Sclerosis: Psychometric Properties of Cognitive and Coordination Fatigability Assessment & Proof-of-concept of a Rehabilitation Intervention
Source: ClinicalTrials.gov · Last updated 22 Jul 2024
Brief summary (registry, in English)
Walking impairments occur in 93% of persons with MS (pwMS) within 10 years of diagnosis. Besides the impact of muscle weakness or hypertonia, one is increasingly aware about the symptom of fatigability. Motor and cognitive fatigability is a change in performance over time depending on the tasks and circumstances. It was shown that up to half of disabled pwMS slow down during walking, impacting on real life mobility. Walking function is related to functional muscle strength, balance and centrally mediated coordination deficits but also cognitive function. Preliminary data conducted by our research group has shown that people with MS with walking fatigability had a significant decrease in movement amplitude during a bipedal coordination task in sitting position. However, the psychometric properties such as within-session and test-retest reliability of bipedal function has not yet been determined. In addition, so far, no interventional research has included exclusively people with MS with walking-related fatigability. It is unknown if the downward curve in walking speed and coordination can be reversed by multi-model interventions. The study will have two parts (A and B). Part A investigates psychometric properties of outcome measures related to fatigability in healthy controls, persons with MS with and without fatigability during walking. Part B is an intervention study in persons with MS and fatigability, comparing dance with a sham intervention, and its effects primarily on fatigability outcomes.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 23 Aug 2021
- Start date
- 1 Sept 2021
- Primary completion date
- 30 Mar 2023
- Lead sponsor
- Hasselt University
- Diseases
- Multiple sclerosis
- NCT number
- NCT05412043
What you commit to
- Study type: Interventional
- Participants enrolled: 16
- From 1 Sept 2021 to the primary completion date, 30 Mar 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cognitive impairment hindering understanding of study instructions,
- musculoskeletal disorders in the lower limbs not related to MS.
Other
- pregnancy
Who the study is looking for
- Persons with MS presenting walking-related fatigability (Distance walk index ≤-10);
- age between 30 and 70 years old;
- a diagnosis of MS (2017 revisions of the McDonalds criteria) with Expanded Disability Status Scale (EDSS) 4 up to 6.5.
- no relapses \>1 month preceding the start of the study
- ability to walk for 6 minutes without rest.
Age in the registry: 30 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Noorderhart Revalidatie & MS centrum Coordinator of this site? Confirm its status | Overpelt | Belgium | Unknown status |
| National MS Center Melsbroek Coordinator of this site? Confirm its status | Overpelt | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.