Effect of Variance on Error Correction During Coupling

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Sclerosis, Progressive Multiple Sclerosis

Intervention / Treatment
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* Other: synchronisation abilities


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: persons with Multiple Sclerosis<br> | Other: synchronisation abilities<br>* 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<br>|
| Experimental: Healthy controls<br> | Other: synchronisation abilities<br>* 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<br>|

What is the study measuring?
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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 |