Clinical trial NCT04856384: Effect of Variance on Error Correction During Coupling
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Progressive Multiple Sclerosis
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: National MS Center Melsbroek
name: Revalidatie & MS Centrum Overpelt
First posted: 2021-04-23
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Motricity Index of dorsi flexors, knee extensors and hip flexors
timeFrame: baseline
measure: Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts
timeFrame: baseline
measure: Scale for the assessment and rating of ataxia
timeFrame: Baseline
measure: Dynamic gait index
timeFrame: Baseline
measure: Time up and Go test
timeFrame: Baseline
measure: 6 minute walking test
timeFrame: Baseline
measure: Brief repeatable battery of Rao
timeFrame: Baseline
measure: Symbol digit mobility test
timeFrame: Baseline
measure: Stroop test 0
timeFrame: Baseline
measure: MS walking scale -12
timeFrame: Baseline
measure: Activities-specific balance confidence scale
timeFrame: Baseline
measure: Modified fatigue impact scale
timeFrame: baseline
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline
measure: Dual task questionnaire
timeFrame: Baseline
measure: Perceptual tempo and rhythm judgements
timeFrame: week 1
measure: Asynchrony
timeFrame: week 1
measure: 64 channel EEG measurement
timeFrame: week 1
measure: Resultant Vector Length
timeFrame: week 2
measure: Resultant Vector Length
timeFrame: week 3
measure: Relative phase angle
timeFrame: week 2
measure: Relative phase angle
timeFrame: week 3
Secondary outcomes:
measure: Cadencce
timeFrame: week 2
measure: Cadencce
timeFrame: week 3
measure: Stride length
timeFrame: week 2
measure: Stride length
timeFrame: week 3
measure: Speed
timeFrame: week 2
measure: Speed
timeFrame: week 3
measure: Double Support
timeFrame: week 2
measure: Double Support
timeFrame: week 3
measure: Perceived cognitive and physical fatigue
timeFrame: week 2
measure: Perceived cognitive and physical fatigue
timeFrame: week 3
measure: Perceived motivation
timeFrame: week 2
measure: Perceived motivation
timeFrame: week 3
measure: Perceived walking speed
timeFrame: week 2
measure: Perceived walking speed
timeFrame: week 3
measure: 64 channel EEG measurement (only conducted in 4 PwMS and HC)
timeFrame: week 2
measure: 64 channel EEG measurement (only conducted in 4 PwMS and HC)
timeFrame: week 3
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: