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

CompletedNot a drug-phase studyMS (type not specified)NCT05412043

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Dance therapy

Given to everyone in the trial

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

What it measured

Main measures

  • The phase coordination index (PCI)

    baselline

  • The phase coordination index (PCI)

    Day 7

  • The phase coordination index (PCI)

    week 8

  • Movement Amplitude- Chair Coordination test

    Baseline

  • Movement Amplitude- Chair Coordination test

    Day 7

  • Movement Amplitude- Chair Coordination test

    Week 8

  • Movement Frequency- Chair Coordination test

    Baseline

  • Movement Frequency- Chair Coordination test

    Day 7

  • Movement Frequency- Chair Coordination test

    week 8

  • Workload- Chair Coordination test

    Baseline

  • Workload- Chair Coordination test

    Day 7

  • Workload- Chair Coordination test

    week 8

  • Motor fatigability during the 6 minutes condition

    Baseline

    Walking and mobility
  • Motor fatigability during the 6 minutes condition

    Day 7

    Walking and mobility
  • Motor fatigability during the 6 minutes condition

    week 8

    Walking and mobility
  • the paced auditory serial addition test (PASAT)

    Baseline

    Thinking and memory
  • the paced auditory serial addition test (PASAT)

    Day 7

    Thinking and memory
  • the paced auditory serial addition test (PASAT)

    week 8

    Thinking and memory
  • the symbol digit modality test (SDMT)

    Baseline

    Thinking and memory
  • the symbol digit modality test (SDMT)

    Day 7

    Thinking and memory
  • the symbol digit modality test (SDMT)

    week 8

    Thinking and memory
  • The 6 minute walking test

    baseline

    Walking and mobility
  • The 6 minute walking test

    Day 7

    Walking and mobility
  • The 6 minute walking test

    week 8

    Walking and mobility

Other measures (39)

  • Spatiotemporal gait parameter- Cadence

    Baseline

    Disability progressionWalking and mobility
  • Spatiotemporal gait parameter- Cadence

    day 7

    Disability progressionWalking and mobility
  • Spatiotemporal gait parameter- Cadence

    week 8

    Disability progressionWalking and mobility
  • Spatiotemporal gait parameter- Stride length

    Baseline

    Disability progressionWalking and mobility
  • Spatiotemporal gait parameter- Stride length

    Day 7

    Disability progressionWalking and mobility
  • Spatiotemporal gait parameter- Stride length

    week 8

    Disability progressionWalking and mobility
  • Spatiotemporal gait parameter- Gait speed

    Baseline

    Disability progressionWalking and mobility
  • Spatiotemporal gait parameter- Gait speed

    Day 7

    Disability progressionWalking and mobility
  • Spatiotemporal gait parameter- Gait speed

    week 8

    Disability progressionWalking and mobility
  • Spatiotemporal gait parameter- Double support

    Baseline

    Disability progressionWalking and mobility

Who could take part

MS (type not specified) · 30 to 70

Show the full criteria

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Sept 2021

    2. Main results due

      Mar 2023

    3. Finished

      May 2024

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