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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04639401
Other study ID # AMCiMS-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 9, 2020
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source Hasselt University
Contact Peter Feys, prof. dr.
Phone +32 11 29 21 23
Email peter.feys@uhasselt.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 8
Est. completion date December 31, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
motor entrainment to auditory cues and music during walking on quality of movement
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.

Locations

Country Name City State
Belgium National MS Center Melsbroek Melsbroek
Belgium Noorderhart Revalidatie & MS centrum Overpelt

Sponsors (3)

Lead Sponsor Collaborator
Hasselt University National MS Center Melsbroek, Revalidatie & MS Centrum Overpelt

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resultant Vector Length synchronisation consistency week 3
Primary Resultant Vector Length synchronisation consistency week 4
Primary Resultant Vector Length synchronisation consistency week 5
Primary Relative phase angle asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively) week 3
Primary Relative phase angle asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively) week 4
Primary Relative phase angle asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively) week 5
Primary Perceptual tempo and rhythm judgements subjective indications in regards to what the participants hear in terms week 2
Primary Asynchrony timing difference between the tap and the beat week2
Primary EEG 64 channel EEG measurement (only conducted in 4 PwMS and HC) -> neural correlates of entrainment week 2
Primary Muscle weakness Motricity Index of dorsi flexors, knee extensors and hip flexors - week 1
Primary Spasticity Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts week 1
Primary Ataxia Scale for the assessment and rating of ataxia week 1
Primary Dynamic gait index dynamic balance week 1
Primary Time up and Go test balance week 1
Primary 6 minute walking test gait pattern and endurance week 1
Primary Brief repeatable battery of Rao cognitive test week 1
Primary Symbol digit mobility test cognitive test week 1
Primary Stroop test 0 cognitive test week 1
Primary MS walking scale -12 impact of MS on walking ability week 1
Primary Activities-specific balance confidence scale rating of balance confidence in performing activities of daily life week 1
Primary Modified fatigue impact scale effect of fatigue week 1
Primary Hospital Anxiety and Depression Scale determine the levels of anxiety and depression week 1
Primary Dual task questionnaire troubles a person have when performing a dual task during daily activity week 1
Secondary Cadence number of steps per minute week 3
Secondary Cadence number of steps per minute week 4
Secondary Cadence number of steps per minute week 5
Secondary Stride length distance between consecutive steps (cm) week 3
Secondary Stride length distance between consecutive steps (cm) week 4
Secondary Stride length distance between consecutive steps (cm) week 5
Secondary speed gait velocity (m/s) week 3
Secondary speed gait velocity (m/s) week 4
Secondary speed gait velocity (m/s) week 5
Secondary Double Support time that both legs are in contact with the floor (mseconds) week 3
Secondary Double Support time that both legs are in contact with the floor (mseconds) week 4
Secondary Double Support time that both legs are in contact with the floor (mseconds) week 5
Secondary 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
Secondary 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 4
Secondary 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 5
Secondary 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
Secondary 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 4
Secondary 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 5
Secondary 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
Secondary 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 4
Secondary 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 5
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