Effect of Variance on Error Correction During Coupling

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

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.

Study Overview

• Status: Completed
• Conditions: Progressive Multiple Sclerosis; Multiple Sclerosis
• Intervention / Treatment: Other: synchronisation abilities

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Melsbroek, Belgium, 1820
    • 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, 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• 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: synchronisation abilities; 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
Experimental: Healthy controls	Other: synchronisation abilities; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cadencce	number of steps per minute	week 2
Cadencce	number of steps per minute	week 3
Stride length	distance between consecutive steps (cm)	week 2
Stride length	distance between consecutive steps (cm)	week 3
Speed	gait velocity (m/s)	week 2
Speed	gait velocity (m/s)	week 3
Double Support	time that both legs are in contact with the floor (mseconds)	week 2
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 2
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 2
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 2
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
64 channel EEG measurement (only conducted in 4 PwMS and HC)	Neural correlates of entrainment	week 2
64 channel EEG measurement (only conducted in 4 PwMS and HC)	Neural correlates of entrainment	week 3

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): February 1, 2021
• Primary Completion (Actual): October 22, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 23, 2021

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; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Chronic Progressive
• Other Study ID Numbers: MS-Music-LM-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