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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04856384
Enrollment
13
Registered
2021-04-23
Start date
2021-02-01
Completion date
2024-12-31
Last updated
2025-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Progressive Multiple Sclerosis

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.

Interventions

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

Sponsors

National MS Center Melsbroek
CollaboratorOTHER
Revalidatie & MS Centrum Overpelt
CollaboratorOTHER
Hasselt University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Relative phase angleweek 2asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)
Activities-specific balance confidence scaleBaselinerating of balance confidence in performing activities of daily life
Modified fatigue impact scalebaselineeffect of fatigue
Hospital Anxiety and Depression ScaleBaselinedetermine the levels of anxiety and depression
Dual task questionnaireBaselinetroubles a person have when performing a dual task during daily activity
Perceptual tempo and rhythm judgementsweek 1subjective indications in regards to what the participants hear in terms
Asynchronyweek 1timing difference between the tap and the beat
64 channel EEG measurementweek 1neural correlates of entrainment
Resultant Vector Lengthweek 2synchronisation consistency
Motricity Index of dorsi flexors, knee extensors and hip flexorsbaselineMuscle weakness
Modified Aschowrth scale Hamstrings, Tricepts Surae, QuadriceptsbaselineSpasticity
Scale for the assessment and rating of ataxiaBaselineataxia
Dynamic gait indexBaselinedynamic balance
Time up and Go testBaselineBalance
6 minute walking testBaselinegait pattern and endurance
Brief repeatable battery of RaoBaselinecognitive test
Symbol digit mobility testBaselinecognitive test
Stroop test 0Baselinecognitive test
MS walking scale -12Baselineimpact of MS on walking ability

Secondary

MeasureTime frameDescription
Stride lengthweek 2distance between consecutive steps (cm)
Speedweek 2gait velocity (m/s)
Double Supportweek 2time that both legs are in contact with the floor (mseconds)
Perceived cognitive and physical fatigueweek 2A 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
Perceived motivationweek 2A Likert scale will be used, and participants will be asked to rate their perceived motivation of walking after each experimental walking conditions
Perceived walking speedweek 2A 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
64 channel EEG measurement (only conducted in 4 PwMS and HC)week 2Neural correlates of entrainment
Cadencceweek 2number of steps per minute

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026