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Clinical Trials/NCT04639401
NCT04639401
Completed
Not Applicable

Effect of Motor Entrainment to Auditory Cues and Music During Walking on Quality of Movement and Percieved Fatigue in Persons with Multiple Sclerosis with Cerebellar Lesions

Hasselt University2 sites in 1 country8 target enrollmentNovember 9, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Hasselt University
Enrollment
8
Locations
2
Primary Endpoint
Resultant Vector Length
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study is a case-control observational study, involving persons with multiple sclerosis and healthy controls. The study contains 1 descriptive and 4 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, at different tempi and alignment strategies. In the latter three sessions, apart from outcome measures of synchronization the following will be collected as well: spatio-temporal gait parameters, perceived fatigue, perceived motivation and perceived speed of walking.

Registry
clinicaltrials.gov
Start Date
November 9, 2020
End Date
February 21, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hasselt University
Responsible Party
Principal Investigator
Principal Investigator

Peter Feys

Principal Investigator

Hasselt University

Eligibility Criteria

Inclusion Criteria

  • diagnosis of Multiple sclerosis \>1 year,
  • type of lesions: cerebellar lesions,
  • 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

Outcomes

Primary Outcomes

Resultant Vector Length

Time Frame: week 5

synchronisation consistency

EEG

Time Frame: week 2

64 channel EEG measurement (only conducted in 4 PwMS and HC) -\> neural correlates of entrainment

Muscle weakness

Time Frame: week 1

Motricity Index of dorsi flexors, knee extensors and hip flexors -

Perceptual tempo and rhythm judgements

Time Frame: week 2

subjective indications in regards to what the participants hear in terms

6 minute walking test

Time Frame: week 1

gait pattern and endurance

Brief repeatable battery of Rao

Time Frame: week 1

cognitive test

MS walking scale -12

Time Frame: week 1

impact of MS on walking ability

Spasticity

Time Frame: week 1

Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts

Ataxia

Time Frame: week 1

Scale for the assessment and rating of ataxia

Time up and Go test

Time Frame: week 1

balance

Symbol digit mobility test

Time Frame: week 1

cognitive test

Stroop test 0

Time Frame: week 1

cognitive test

Modified fatigue impact scale

Time Frame: week 1

effect of fatigue

Dual task questionnaire

Time Frame: week 1

troubles a person have when performing a dual task during daily activity

Relative phase angle

Time Frame: week 5

asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)

Asynchrony

Time Frame: week2

timing difference between the tap and the beat

Dynamic gait index

Time Frame: week 1

dynamic balance

Activities-specific balance confidence scale

Time Frame: week 1

rating of balance confidence in performing activities of daily life

Hospital Anxiety and Depression Scale

Time Frame: week 1

determine the levels of anxiety and depression

Secondary Outcomes

  • Cadence(week 5)
  • Stride length(week 5)
  • Perceived cognitive and physical fatigue(week 5)
  • Perceived walking speed(week 5)
  • speed(week 5)
  • Double Support(week 5)
  • Perceived motivation(week 5)

Study Sites (2)

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