Fatigability in Persons With Multiple Sclerosis: Inputs From Cognition, Walking and Coordination

Multiple Sclerosis Clinical Trial

Official title: Walking-related Fatigability in Persons With Multiple Sclerosis: Psychometric Properties of Cognitive and Coordination Fatigability Assessment & Proof-of-concept of a Rehabilitation Intervention

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

The study will have two parts (A and B). Part A includes 60 persons with Multiple Sclerosis (pwMS) and 30 healthy controls. The study consists of 2 test sessions, separated by 5-7 days of interval. The sessions 1 and 2 will be composed of cognitive test battery, questionnaires to be filled, information about the use of actigraph, clinical outcomes and interlimb coordination tests.

In the Part B the investigators propose a pilot randomized controlled trial with dance therapy to improve fatigability in pwMS. The study includes 24 pwMS presenting walking fatigability. The participants will be randomly allocated by group (n=3-4), by a person independent from the research, into the intervention group (Dance Therapy) or the active control group (control exercise). Interventions take place in groups of 3 or 4 people with MS, twice a week for eight weeks, complementary to their usual care or conventional physiotherapy. ;

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

• NCT number: NCT05412043
• Study type: Interventional
• Source: Hasselt University
• Contact: Peter Feys, prof. dr.
• Phone: +32 11 26 21 23
• Email: peter.feys@uhasselt.be
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Completion date: September 30, 2022