Auditory-motor Coupling in Multiple Sclerosis with Cerebellar Lesions

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Cerebral Lesion
• Intervention / Treatment: Other: motor entrainment to auditory cues and music during walking on quality of movement

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Melsbroek, Belgium
    • National MS Center Melsbroek
  • Overpelt, Belgium, 3900
    • Noorderhart Revalidatie & MS centrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: persons with Multiple Sclerosis	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.
Placebo Comparator: Healthy controls	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Revalidatie & MS Centrum Overpelt; National MS Center Melsbroek
• Investigators: Principal Investigator: Peter Feys, prof. dr., Hasselt University; Study Chair: Lousin Moumdjian, dr., Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): February 21, 2025

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: AMCiMS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No