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Completed

NCT Number: NCT04639401

Auditory-motor Coupling in Multiple Sclerosis With Cerebellar Lesions

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Cerebral Lesion Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National MS Center Melsbroek, Melsbroek, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

motor entrainment to auditory cues and music during walking on quality of movement

Other

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.

Primary outcomes

  1. Resultant Vector Length

    Time frame: week 3

    synchronisation consistency

  2. Resultant Vector Length

    Time frame: week 4

    synchronisation consistency

  3. Resultant Vector Length

    Time frame: week 5

    synchronisation consistency

  4. Relative phase angle

    Time frame: week 3

    asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)

  5. Relative phase angle

    Time frame: week 4

    asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)

  6. Relative phase angle

    Time frame: week 5

    asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)

  7. Perceptual tempo and rhythm judgements

    Time frame: week 2

    subjective indications in regards to what the participants hear in terms

  8. Asynchrony

    Time frame: week2

    timing difference between the tap and the beat

  9. EEG

    Time frame: week 2

    64 channel EEG measurement (only conducted in 4 PwMS and HC) -> neural correlates of entrainment

  10. Muscle weakness

    Time frame: week 1

    Motricity Index of dorsi flexors, knee extensors and hip flexors -

  11. Spasticity

    Time frame: week 1

    Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts

  12. Ataxia

    Time frame: week 1

    Scale for the assessment and rating of ataxia

  13. Dynamic gait index

    Time frame: week 1

    dynamic balance

  14. Time up and Go test

    Time frame: week 1

    balance

  15. 6 minute walking test

    Time frame: week 1

    gait pattern and endurance

  16. Brief repeatable battery of Rao

    Time frame: week 1

    cognitive test

  17. Symbol digit mobility test

    Time frame: week 1

    cognitive test

  18. Stroop test 0

    Time frame: week 1

    cognitive test

  19. MS walking scale -12

    Time frame: week 1

    impact of MS on walking ability

  20. Activities-specific balance confidence scale

    Time frame: week 1

    rating of balance confidence in performing activities of daily life

  21. Modified fatigue impact scale

    Time frame: week 1

    effect of fatigue

  22. Hospital Anxiety and Depression Scale

    Time frame: week 1

    determine the levels of anxiety and depression

  23. Dual task questionnaire

    Time frame: week 1

    troubles a person have when performing a dual task during daily activity

Secondary outcomes

  1. Cadence

    Time frame: week 3

    number of steps per minute

  2. Cadence

    Time frame: week 4

    number of steps per minute

  3. Cadence

    Time frame: week 5

    number of steps per minute

  4. Stride length

    Time frame: week 3

    distance between consecutive steps (cm)

  5. Stride length

    Time frame: week 4

    distance between consecutive steps (cm)

  6. Stride length

    Time frame: week 5

    distance between consecutive steps (cm)

  7. speed

    Time frame: week 3

    gait velocity (m/s)

  8. speed

    Time frame: week 4

    gait velocity (m/s)

  9. speed

    Time frame: week 5

    gait velocity (m/s)

  10. Double Support

    Time frame: week 3

    time that both legs are in contact with the floor (mseconds)

  11. Double Support

    Time frame: week 4

    time that both legs are in contact with the floor (mseconds)

  12. Double Support

    Time frame: week 5

    time that both legs are in contact with the floor (mseconds)

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • National MS Center Melsbroek
  • Revalidatie & MS Centrum Overpelt

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Nov 20, 2020
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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