Auditory-motor Coupling in Multiple Sclerosis With Cerebellar Lesions

Overview

This study is a case-control observational study, involving persons with multiple sclerosis and healthy controls. The study contains 1 descriptive and 4 experimental sessions. In the descriptive session, participant's clinical motor and cognitive functions are collected. In the first experimental session, participant's beat perception and synchronisation abilities is examined within a finger tapping paradigm. In the following experimental sessions participants synchronsiation abilities is examined during walking paradigms, to music and metronomes, at different tempi and alignment strategies. In the latter three sessions, apart from outcome measures of synchronization the following will be collected as well: spatio-temporal gait parameters, perceived fatigue, perceived motivation and perceived speed of walking.

Full Title of Study: “Effect of Motor Entrainment to Auditory Cues and Music During Walking on Quality of Movement and Percieved Fatigue in Persons With Multiple Sclerosis With Cerebellar Lesions”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2022

Interventions

  • Other: motor entrainment to auditory cues and music during walking on quality of movement
    • The study contains 1 descriptive and 4 experimental sessions. In the descriptive session, participant’s clinical motor and cognitive functions are collected. In the first experimental session, participant’s beat perception and synchronisation abilities is examined within a finger tapping paradigm. In the following experimental sessions participants synchronsiation abilities is examined during walking paradigms, to music and metronomes, at different tempi and alignment strategies. In the latter three sessions, apart from outcome measures of synchronization the following will be collected as well: spatio-temporal gait parameters, perceived fatigue, perceived motivation and perceived speed of walking.

Arms, Groups and Cohorts

  • Experimental: persons with Multiple Sclerosis
  • Placebo Comparator: Healthy controls

Clinical Trial Outcome Measures

Primary Measures

  • Resultant Vector Length
    • Time Frame: week 3
    • synchronisation consistency
  • Resultant Vector Length
    • Time Frame: week 4
    • synchronisation consistency
  • Resultant Vector Length
    • Time Frame: week 5
    • synchronisation consistency
  • Relative phase angle
    • Time Frame: week 3
    • asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)
  • Relative phase angle
    • Time Frame: week 4
    • asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)
  • Relative phase angle
    • Time Frame: week 5
    • asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)
  • Perceptual tempo and rhythm judgements
    • Time Frame: week 2
    • subjective indications in regards to what the participants hear in terms
  • Asynchrony
    • Time Frame: week2
    • timing difference between the tap and the beat
  • EEG
    • Time Frame: week 2
    • 64 channel EEG measurement (only conducted in 4 PwMS and HC) -> neural correlates of entrainment
  • Muscle weakness
    • Time Frame: week 1
    • Motricity Index of dorsi flexors, knee extensors and hip flexors -
  • Spasticity
    • Time Frame: week 1
    • Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts
  • Ataxia
    • Time Frame: week 1
    • Scale for the assessment and rating of ataxia
  • Dynamic gait index
    • Time Frame: week 1
    • dynamic balance
  • Time up and Go test
    • Time Frame: week 1
    • balance
  • 6 minute walking test
    • Time Frame: week 1
    • gait pattern and endurance
  • Brief repeatable battery of Rao
    • Time Frame: week 1
    • cognitive test
  • Symbol digit mobility test
    • Time Frame: week 1
    • cognitive test
  • Stroop test 0
    • Time Frame: week 1
    • cognitive test
  • MS walking scale -12
    • Time Frame: week 1
    • impact of MS on walking ability
  • Activities-specific balance confidence scale
    • Time Frame: week 1
    • rating of balance confidence in performing activities of daily life
  • Modified fatigue impact scale
    • Time Frame: week 1
    • effect of fatigue
  • Hospital Anxiety and Depression Scale
    • Time Frame: week 1
    • determine the levels of anxiety and depression
  • Dual task questionnaire
    • Time Frame: week 1
    • troubles a person have when performing a dual task during daily activity

Secondary Measures

  • Cadence
    • Time Frame: week 3
    • number of steps per minute
  • Cadence
    • Time Frame: week 4
    • number of steps per minute
  • Cadence
    • Time Frame: week 5
    • number of steps per minute
  • Stride length
    • Time Frame: week 3
    • distance between consecutive steps (cm)
  • Stride length
    • Time Frame: week 4
    • distance between consecutive steps (cm)
  • Stride length
    • Time Frame: week 5
    • distance between consecutive steps (cm)
  • speed
    • Time Frame: week 3
    • gait velocity (m/s)
  • speed
    • Time Frame: week 4
    • gait velocity (m/s)
  • speed
    • Time Frame: week 5
    • gait velocity (m/s)
  • Double Support
    • Time Frame: week 3
    • time that both legs are in contact with the floor (mseconds)
  • Double Support
    • Time Frame: week 4
    • time that both legs are in contact with the floor (mseconds)
  • Double Support
    • Time Frame: week 5
    • time that both legs are in contact with the floor (mseconds)
  • Perceived cognitive and physical fatigue
    • Time Frame: week 3
    • A visual analogue scale will be used, and participants will be asked to rate their perceived cognitive and physical fatigue levels before and after each experimental walking conditions
  • Perceived cognitive and physical fatigue
    • Time Frame: week 4
    • A visual analogue scale will be used, and participants will be asked to rate their perceived cognitive and physical fatigue levels before and after each experimental walking conditions
  • Perceived cognitive and physical fatigue
    • Time Frame: week 5
    • A visual analogue scale will be used, and participants will be asked to rate their perceived cognitive and physical fatigue levels before and after each experimental walking conditions
  • Perceived motivation
    • Time Frame: week 3
    • A Likert scale will be used, and participants will be asked to rate their perceived motivation of walking after each experimental walking conditions
  • Perceived motivation
    • Time Frame: week 4
    • A Likert scale will be used, and participants will be asked to rate their perceived motivation of walking after each experimental walking conditions
  • Perceived motivation
    • Time Frame: week 5
    • A Likert scale will be used, and participants will be asked to rate their perceived motivation of walking after each experimental walking conditions
  • Perceived walking speed
    • Time Frame: week 3
    • A Likert scale will be used, and participants will be asked to rate their perceived walking speed relative to their usual walking after each experimental walking conditions
  • Perceived walking speed
    • Time Frame: week 4
    • A Likert scale will be used, and participants will be asked to rate their perceived walking speed relative to their usual walking after each experimental walking conditions
  • Perceived walking speed
    • Time Frame: week 5
    • A Likert scale will be used, and participants will be asked to rate their perceived walking speed relative to their usual walking after each experimental walking conditions

Participating in This Clinical Trial

Inclusion Criteria

  • diagnosis of Multiple sclerosis >1 year, – type of lesions: cerebellar lesions, – walking speed 0.8-1.2m/s, ability to walk for 6 minutes continuously (canes and rollators are permitted). Exclusion Criteria:
  • relapse 3 months prior to enrollment, – cognitive impairment impeding understanding of instructions, – beat amusia, – deafness, – pregnancy
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 70 Years

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • Hasselt University
    • Collaborator
      • National MS Center Melsbroek
    • Provider of Information About this Clinical Study
      • Principal Investigator: Peter Feys, Principal Investigator – Hasselt University
    • Overall Official(s)
      • Peter Feys, prof. dr., Principal Investigator, Hasselt University
      • Lousin Moumdjian, dr., Study Chair, Hasselt University
    • Overall Contact(s)
      • Peter Feys, prof. dr., +32 11 29 21 23, peter.feys@uhasselt.be

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