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Completed

NCT Number: NCT04856384

Effect of Variance on Error Correction During Coupling

This study is a case-control study, involving persons with progressive multiple sclerosis and healthy controls. The study contains 1 descriptive and 3 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, with period and phase auditory manipulations. In the latter twp sessions, apart from outcome measures of synchronization the following will be collected as well: brain activity using EEG recordings, 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 Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis, Chronic Progressive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Progressive Multiple Sclerosis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National MS Center Melsbroek, Melsbroek, Belgium

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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, diagnosis of progressive MS,
  • 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

synchronisation abilities

Other

The study contains 1 descriptive and 3 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, with period and phase auditory manipulations

Primary outcomes

  1. Motricity Index of dorsi flexors, knee extensors and hip flexors

    Time frame: baseline

    Muscle weakness

  2. Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts

    Time frame: baseline

    Spasticity

  3. Scale for the assessment and rating of ataxia

    Time frame: Baseline

    ataxia

  4. Dynamic gait index

    Time frame: Baseline

    dynamic balance

  5. Time up and Go test

    Time frame: Baseline

    Balance

  6. 6 minute walking test

    Time frame: Baseline

    gait pattern and endurance

  7. Brief repeatable battery of Rao

    Time frame: Baseline

    cognitive test

  8. Symbol digit mobility test

    Time frame: Baseline

    cognitive test

  9. Stroop test 0

    Time frame: Baseline

    cognitive test

  10. MS walking scale -12

    Time frame: Baseline

    impact of MS on walking ability

  11. Activities-specific balance confidence scale

    Time frame: Baseline

    rating of balance confidence in performing activities of daily life

  12. Modified fatigue impact scale

    Time frame: baseline

    effect of fatigue

  13. Hospital Anxiety and Depression Scale

    Time frame: Baseline

    determine the levels of anxiety and depression

  14. Dual task questionnaire

    Time frame: Baseline

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

  15. Perceptual tempo and rhythm judgements

    Time frame: week 1

    subjective indications in regards to what the participants hear in terms

  16. Asynchrony

    Time frame: week 1

    timing difference between the tap and the beat

  17. 64 channel EEG measurement

    Time frame: week 1

    neural correlates of entrainment

  18. Resultant Vector Length

    Time frame: week 2

    synchronisation consistency

  19. Resultant Vector Length

    Time frame: week 3

    synchronisation consistency

  20. Relative phase angle

    Time frame: week 2

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

  21. Relative phase angle

    Time frame: week 3

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

Secondary outcomes

  1. Cadencce

    Time frame: week 2

    number of steps per minute

  2. Cadencce

    Time frame: week 3

    number of steps per minute

  3. Stride length

    Time frame: week 2

    distance between consecutive steps (cm)

  4. Stride length

    Time frame: week 3

    distance between consecutive steps (cm)

  5. Speed

    Time frame: week 2

    gait velocity (m/s)

  6. Speed

    Time frame: week 3

    gait velocity (m/s)

  7. Double Support

    Time frame: week 2

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

  8. Double Support

    Time frame: week 3

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

  9. Perceived cognitive and physical fatigue

    Time frame: week 2

    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

  10. 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

  11. Perceived motivation

    Time frame: week 2

    A Likert scale will be used, and participants will be asked to rate their perceived motivation of walking after each experimental walking conditions

  12. 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

  13. Perceived walking speed

    Time frame: week 2

    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

  14. 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

  15. 64 channel EEG measurement (only conducted in 4 PwMS and HC)

    Time frame: week 2

    Neural correlates of entrainment

  16. 64 channel EEG measurement (only conducted in 4 PwMS and HC)

    Time frame: week 3

    Neural correlates of entrainment

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • National MS Center Melsbroek
  • Revalidatie & MS Centrum Overpelt

Registry information

Official study title

Understanding the Effect of Variances on Precision in Predictive Coding When Walking to Music and Metronomes in Persons With Multiple Sclerosis With Progressive Subtypes.

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 23, 2021
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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