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

Hasselt University

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: Psychometric properties (Validity, Reliability) of interlimb coordination- and cognitive-fatigability; Behavioral: Dance therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05412043

Fatigability-MS-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Cognitive impairment hindering understanding of study instructions,
• pregnancy
• musculoskeletal disorders in the lower limbs not related to MS.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 3 patient groups, including a placebo group

Persons with MS - Dance group

Experimental group

Description:

12 pwMS in the Dance Therapy intervention

Treatment:

Behavioral: Dance therapy

Other: Psychometric properties (Validity, Reliability) of interlimb coordination- and cognitive-fatigability

persons with MS - excercise group

Active Comparator group

Description:

12 pwMS in the exercise (placebo) group

Treatment:

Other: Psychometric properties (Validity, Reliability) of interlimb coordination- and cognitive-fatigability

Healthy controls

Placebo Comparator group

Treatment:

Other: Psychometric properties (Validity, Reliability) of interlimb coordination- and cognitive-fatigability