Clinical trial NCT04639401: Auditory-motor Coupling in Multiple Sclerosis With Cerebellar Lesions
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Cerebral Lesion
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: National MS Center Melsbroek
name: Revalidatie & MS Centrum Overpelt
First posted: 2020-11-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Resultant Vector Length
timeFrame: week 3
measure: Resultant Vector Length
timeFrame: week 4
measure: Resultant Vector Length
timeFrame: week 5
measure: Relative phase angle
timeFrame: week 3
measure: Relative phase angle
timeFrame: week 4
measure: Relative phase angle
timeFrame: week 5
measure: Perceptual tempo and rhythm judgements
timeFrame: week 2
measure: Asynchrony
timeFrame: week2
measure: EEG
timeFrame: week 2
measure: Muscle weakness
timeFrame: week 1
measure: Spasticity
timeFrame: week 1
measure: Ataxia
timeFrame: week 1
measure: Dynamic gait index
timeFrame: week 1
measure: Time up and Go test
timeFrame: week 1
measure: 6 minute walking test
timeFrame: week 1
measure: Brief repeatable battery of Rao
timeFrame: week 1
measure: Symbol digit mobility test
timeFrame: week 1
measure: Stroop test 0
timeFrame: week 1
measure: MS walking scale -12
timeFrame: week 1
measure: Activities-specific balance confidence scale
timeFrame: week 1
measure: Modified fatigue impact scale
timeFrame: week 1
measure: Hospital Anxiety and Depression Scale
timeFrame: week 1
measure: Dual task questionnaire
timeFrame: week 1
Secondary outcomes:
measure: Cadence
timeFrame: week 3
measure: Cadence
timeFrame: week 4
measure: Cadence
timeFrame: week 5
measure: Stride length
timeFrame: week 3
measure: Stride length
timeFrame: week 4
measure: Stride length
timeFrame: week 5
measure: speed
timeFrame: week 3
measure: speed
timeFrame: week 4
measure: speed
timeFrame: week 5
measure: Double Support
timeFrame: week 3
measure: Double Support
timeFrame: week 4
measure: Double Support
timeFrame: week 5
measure: Perceived cognitive and physical fatigue
timeFrame: week 3
measure: Perceived cognitive and physical fatigue
timeFrame: week 4
measure: Perceived cognitive and physical fatigue
timeFrame: week 5
measure: Perceived motivation
timeFrame: week 3
measure: Perceived motivation
timeFrame: week 4
measure: Perceived motivation
timeFrame: week 5
measure: Perceived walking speed
timeFrame: week 3
measure: Perceived walking speed
timeFrame: week 4
measure: Perceived walking speed
timeFrame: week 5
Other outcomes:
Locations:
city: Melsbroek
country: Belgium
facility: National MS Center Melsbroek
city: Overpelt
country: Belgium
facility: Noorderhart Revalidatie & MS centrum
Study officials:
affiliation: Hasselt University
name: Peter Feys, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Lousin Moumdjian, dr.
role: STUDY_CHAIR
References: