Auditory-motor Coupling in Multiple Sclerosis With Cerebellar Lesions

Multiple Sclerosis Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04639401
• Other study ID #: AMCiMS-001
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Hasselt University
• Contact: Peter Feys, prof. dr.
• Phone: +32 11 29 21 23
• Email: peter.feys[@]uhasselt.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Lesion
• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Belgium	National MS Center Melsbroek	Melsbroek
Belgium	Noorderhart Revalidatie & MS centrum	Overpelt

Sponsors (3)

Lead Sponsor	Collaborator
Hasselt University	National MS Center Melsbroek, Revalidatie & MS Centrum Overpelt

Country where clinical trial is conducted

Belgium, 

Outcome

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