Effect of Variance on Error Correction During Coupling

February 25, 2025 updated by: Peter Feys, Hasselt University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Melsbroek, Belgium, 1820
        • National MS Center Melsbroek
      • Overpelt, Belgium, 3900
        • Noorderhart Revalidatie & MS centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cadencce
Time Frame: week 2
number of steps per minute
week 2
Cadencce
Time Frame: week 3
number of steps per minute
week 3
Stride length
Time Frame: week 2
distance between consecutive steps (cm)
week 2
Stride length
Time Frame: week 3
distance between consecutive steps (cm)
week 3
Speed
Time Frame: week 2
gait velocity (m/s)
week 2
Speed
Time Frame: week 3
gait velocity (m/s)
week 3
Double Support
Time Frame: week 2
time that both legs are in contact with the floor (mseconds)
week 2
Double Support
Time Frame: week 3
time that both legs are in contact with the floor (mseconds)
week 3
Perceived cognitive and physical fatigue
Time Frame: week 2
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
Time Frame: week 3
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
Time Frame: week 2
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
Time Frame: week 3
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
Time Frame: week 2
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
Time Frame: week 3
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)
Time Frame: week 2
Neural correlates of entrainment
week 2
64 channel EEG measurement (only conducted in 4 PwMS and HC)
Time Frame: week 3
Neural correlates of entrainment
week 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasselt University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Revalidatie & MS Centrum Overpelt
National MS Center Melsbroek

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Feys, prof. dr., Hasselt University
  • Study Chair: Lousin Moumdjian, dr., Hasselt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 22, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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