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Auditory-motor Coupling in Multiple Sclerosis With Cerebellar Lesions

Primary Purpose

Multiple Sclerosis, Cerebral Lesion

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
motor entrainment to auditory cues and music during walking on quality of movement
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National MS Center MelsbroekRecruiting
  • Noorderhart Revalidatie & MS centrumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

persons with Multiple Sclerosis

Healthy controls

Arm Description

Outcomes

Primary Outcome Measures

Resultant Vector Length
synchronisation consistency
Resultant Vector Length
synchronisation consistency
Resultant Vector Length
synchronisation consistency
Relative phase angle
asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)
Relative phase angle
asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)
Relative phase angle
asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)
Perceptual tempo and rhythm judgements
subjective indications in regards to what the participants hear in terms
Asynchrony
timing difference between the tap and the beat
EEG
64 channel EEG measurement (only conducted in 4 PwMS and HC) -> neural correlates of entrainment
Muscle weakness
Motricity Index of dorsi flexors, knee extensors and hip flexors -
Spasticity
Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts
Ataxia
Scale for the assessment and rating of ataxia
Dynamic gait index
dynamic balance
Time up and Go test
balance
6 minute walking test
gait pattern and endurance
Brief repeatable battery of Rao
cognitive test
Symbol digit mobility test
cognitive test
Stroop test 0
cognitive test
MS walking scale -12
impact of MS on walking ability
Activities-specific balance confidence scale
rating of balance confidence in performing activities of daily life
Modified fatigue impact scale
effect of fatigue
Hospital Anxiety and Depression Scale
determine the levels of anxiety and depression
Dual task questionnaire
troubles a person have when performing a dual task during daily activity

Secondary Outcome Measures

Cadence
number of steps per minute
Cadence
number of steps per minute
Cadence
number of steps per minute
Stride length
distance between consecutive steps (cm)
Stride length
distance between consecutive steps (cm)
Stride length
distance between consecutive steps (cm)
speed
gait velocity (m/s)
speed
gait velocity (m/s)
speed
gait velocity (m/s)
Double Support
time that both legs are in contact with the floor (mseconds)
Double Support
time that both legs are in contact with the floor (mseconds)
Double Support
time that both legs are in contact with the floor (mseconds)
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
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
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
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
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
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
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
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
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

Full Information

First Posted
November 9, 2020
Last Updated
November 17, 2020
Sponsor
Hasselt University
Collaborators
National MS Center Melsbroek, Revalidatie & MS Centrum Overpelt
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1. Study Identification

Unique Protocol Identification Number
NCT04639401
Brief Title
Auditory-motor Coupling in Multiple Sclerosis With Cerebellar Lesions
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
National MS Center Melsbroek, Revalidatie & MS Centrum Overpelt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Cerebral Lesion

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
persons with Multiple Sclerosis
Arm Type
Experimental
Arm Title
Healthy controls
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
motor entrainment to auditory cues and music during walking on quality of movement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Resultant Vector Length
Description
synchronisation consistency
Time Frame
week 3
Title
Resultant Vector Length
Description
synchronisation consistency
Time Frame
week 4
Title
Resultant Vector Length
Description
synchronisation consistency
Time Frame
week 5
Title
Relative phase angle
Description
asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)
Time Frame
week 3
Title
Relative phase angle
Description
asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)
Time Frame
week 4
Title
Relative phase angle
Description
asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)
Time Frame
week 5
Title
Perceptual tempo and rhythm judgements
Description
subjective indications in regards to what the participants hear in terms
Time Frame
week 2
Title
Asynchrony
Description
timing difference between the tap and the beat
Time Frame
week2
Title
EEG
Description
64 channel EEG measurement (only conducted in 4 PwMS and HC) -> neural correlates of entrainment
Time Frame
week 2
Title
Muscle weakness
Description
Motricity Index of dorsi flexors, knee extensors and hip flexors -
Time Frame
week 1
Title
Spasticity
Description
Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts
Time Frame
week 1
Title
Ataxia
Description
Scale for the assessment and rating of ataxia
Time Frame
week 1
Title
Dynamic gait index
Description
dynamic balance
Time Frame
week 1
Title
Time up and Go test
Description
balance
Time Frame
week 1
Title
6 minute walking test
Description
gait pattern and endurance
Time Frame
week 1
Title
Brief repeatable battery of Rao
Description
cognitive test
Time Frame
week 1
Title
Symbol digit mobility test
Description
cognitive test
Time Frame
week 1
Title
Stroop test 0
Description
cognitive test
Time Frame
week 1
Title
MS walking scale -12
Description
impact of MS on walking ability
Time Frame
week 1
Title
Activities-specific balance confidence scale
Description
rating of balance confidence in performing activities of daily life
Time Frame
week 1
Title
Modified fatigue impact scale
Description
effect of fatigue
Time Frame
week 1
Title
Hospital Anxiety and Depression Scale
Description
determine the levels of anxiety and depression
Time Frame
week 1
Title
Dual task questionnaire
Description
troubles a person have when performing a dual task during daily activity
Time Frame
week 1
Secondary Outcome Measure Information:
Title
Cadence
Description
number of steps per minute
Time Frame
week 3
Title
Cadence
Description
number of steps per minute
Time Frame
week 4
Title
Cadence
Description
number of steps per minute
Time Frame
week 5
Title
Stride length
Description
distance between consecutive steps (cm)
Time Frame
week 3
Title
Stride length
Description
distance between consecutive steps (cm)
Time Frame
week 4
Title
Stride length
Description
distance between consecutive steps (cm)
Time Frame
week 5
Title
speed
Description
gait velocity (m/s)
Time Frame
week 3
Title
speed
Description
gait velocity (m/s)
Time Frame
week 4
Title
speed
Description
gait velocity (m/s)
Time Frame
week 5
Title
Double Support
Description
time that both legs are in contact with the floor (mseconds)
Time Frame
week 3
Title
Double Support
Description
time that both legs are in contact with the floor (mseconds)
Time Frame
week 4
Title
Double Support
Description
time that both legs are in contact with the floor (mseconds)
Time Frame
week 5
Title
Perceived cognitive and physical fatigue
Description
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
Time Frame
week 3
Title
Perceived cognitive and physical fatigue
Description
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
Time Frame
week 4
Title
Perceived cognitive and physical fatigue
Description
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
Time Frame
week 5
Title
Perceived motivation
Description
A Likert scale will be used, and participants will be asked to rate their perceived motivation of walking after each experimental walking conditions
Time Frame
week 3
Title
Perceived motivation
Description
A Likert scale will be used, and participants will be asked to rate their perceived motivation of walking after each experimental walking conditions
Time Frame
week 4
Title
Perceived motivation
Description
A Likert scale will be used, and participants will be asked to rate their perceived motivation of walking after each experimental walking conditions
Time Frame
week 5
Title
Perceived walking speed
Description
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
Time Frame
week 3
Title
Perceived walking speed
Description
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
Time Frame
week 4
Title
Perceived walking speed
Description
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
Time Frame
week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Feys, prof. dr.
Phone
+32 11 29 21 23
Email
peter.feys@uhasselt.be
First Name & Middle Initial & Last Name or Official Title & Degree
Lousin moumdjian
Phone
+32 11 26 93 71
Email
lousin.moumdjian@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Feys, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lousin Moumdjian, dr.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
National MS Center Melsbroek
City
Melsbroek
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lousin moumdjian, dr.
Phone
+32 11 26 93 71
Email
lousine.moumdjian@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Johan Van Nieuwenhoven
Phone
+32 03 597 80 42
Facility Name
Noorderhart Revalidatie & MS centrum
City
Overpelt
ZIP/Postal Code
3900
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lousin moumdjian, dr.
Phone
+32 11 26 93 71
Email
lousine.moumdjian@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Ilse Lamers, dr.
Phone
+32 11 28 69 39
Email
ilse.lamers@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Ilse Bosmans
First Name & Middle Initial & Last Name & Degree
Ilse Lamers, dr.

12. IPD Sharing Statement

Learn more about this trial

Auditory-motor Coupling in Multiple Sclerosis With Cerebellar Lesions

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