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Running Title: Walking to Music and in Silence on a Treadmill

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Walking with music with synchronisation
Walking with music without synchronisation
walking without music
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A diagnosis of MS if >1,
  • no relapses >1 month,
  • ability to walk for 12minutes,
  • ability to walk independently on a treadmill
  • walking speed between 0.8-1.2m/s.

Exclusion Criteria:

  • amusia,
  • deafness,
  • cognitive impairment hindering understanding of study instructions,
  • pregnancy.

Sites / Locations

  • Noorderhart Revalidatie & MS centrumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Music with synchronising

Music without synchronising

No music

Arm Description

walking to music that one can synchronise to

walking to music that one cannot synchronise to

walking without music.

Outcomes

Primary Outcome Measures

12- item multiple sclerosis walking scale
The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation.
12- item multiple sclerosis walking scale
The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation.
6 minutes walking test to calculate the distance walking Index
impact of MS on walking
6 minutes walking test to calculate the distance walking Index
impact of MS on walking
12 minute walking with sensors
gait dynamics and pattern - detrended fluctuation analysis and spatio-temporal parameters
12 minute walking with sensors
gait dynamics and pattern - detrended fluctuation analysis and spatio-temporal parameters

Secondary Outcome Measures

Paced auditory serial addition test and symbol digit modality test
to measure cognitive functioning and cognitive fatigability
Paced auditory serial addition test and symbol digit modality test
to measure cognitive functioning and cognitive fatigability
Motricity Index of dorsi flexors, knee extensors and hip flexors
Muscle weakness
Motricity Index of dorsi flexors, knee extensors and hip flexors
Muscle weakness
Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts
Spasticity
Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts
Spasticity
Scale for the assessment and rating of ataxia
Ataxia
Scale for the assessment and rating of ataxia
Ataxia
Dynamic gait index
Dynamic balance
Dynamic gait index
Dynamic balance
Time up and Go test
balance
Time up and Go test
balance
Modified fatigue impact scale
self-reported outcomes for fatigue
Modified fatigue impact scale
self-reported outcomes for fatigue
Barcelona music reward questionnaire
experience of music reward
Barcelona music reward questionnaire
experience of music reward
Hospital anxiety and depression questionnaire
anxiety and depression
Hospital anxiety and depression questionnaire
anxiety and depression
Activities-specific balance confidence scale
self-reported outcome for activity and balance
Activities-specific balance confidence scale
self-reported outcome for activity and balance
Stroke rehabilitation motivation scale
self-reported motivation questionnaire
Stroke rehabilitation motivation scale
self-reported motivation questionnaire
the Brunnel Music Rating Inventory-2
self-reported music rating inventory
the Brunnel Music Rating Inventory-2
self-reported music rating inventory
credibility and expectations questionnaire
self-reporting of credibility of the intervention.
Pre and Post training sessions, 2x a week, 20 minutes for 4 weeks
Before and after each training session Perceived cognitive and physical fatigue rated on a visual analogue scale Perceived motivation rated on a Likert scale

Full Information

First Posted
February 2, 2021
Last Updated
April 19, 2021
Sponsor
Hasselt University
Collaborators
Revalidatie & MS Centrum Overpelt
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1. Study Identification

Unique Protocol Identification Number
NCT04856345
Brief Title
Running Title: Walking to Music and in Silence on a Treadmill
Official Title
The Effect of a 4 Week Auditory-motor Coupling Intervention on Walking, Information Processing Speed and Fatigue in Persons With Multiple Sclerosis: Three Armed Pilot Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 22, 2021 (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
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 work is embedded in the context of auditory-motor coupling, which entails the engagement of two systems; the interaction between the music (or repetitive auditory stimuli) and a walking individual (repetitive movements of footfall). In previous studies, the investigators have shown that synchronising steps to beats in music have shown to be feasible in persons with multiple sclerosis, showing increase of step frequency and reduced perceived fatigue[1, 2]. In this current work, The investigators expand previous findings with a pilot intervention study, to investigate if synchronisation is necessary to improve cognitive and motor functions. The proposed experiment includes 30 participants, randomised to three arms of a pilot intervention (10 participants per arm). With the intention of a further case-study analysis, the inestigators request to include 4 additional participants (2 PwMS with cognitive impairment, and 2 persons with cerebellar lesion) to only follow the intervention arm 1.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Music with synchronising
Arm Type
Experimental
Arm Description
walking to music that one can synchronise to
Arm Title
Music without synchronising
Arm Type
Active Comparator
Arm Description
walking to music that one cannot synchronise to
Arm Title
No music
Arm Type
Sham Comparator
Arm Description
walking without music.
Intervention Type
Other
Intervention Name(s)
Walking with music with synchronisation
Intervention Description
Walking with music than one can synch to
Intervention Type
Other
Intervention Name(s)
Walking with music without synchronisation
Intervention Description
Walking with music than one cannot synch to
Intervention Type
Other
Intervention Name(s)
walking without music
Intervention Description
Walking without music
Primary Outcome Measure Information:
Title
12- item multiple sclerosis walking scale
Description
The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation.
Time Frame
Baseline
Title
12- item multiple sclerosis walking scale
Description
The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation.
Time Frame
week 5
Title
6 minutes walking test to calculate the distance walking Index
Description
impact of MS on walking
Time Frame
Baseline
Title
6 minutes walking test to calculate the distance walking Index
Description
impact of MS on walking
Time Frame
week 5
Title
12 minute walking with sensors
Description
gait dynamics and pattern - detrended fluctuation analysis and spatio-temporal parameters
Time Frame
Baseline
Title
12 minute walking with sensors
Description
gait dynamics and pattern - detrended fluctuation analysis and spatio-temporal parameters
Time Frame
week 5
Secondary Outcome Measure Information:
Title
Paced auditory serial addition test and symbol digit modality test
Description
to measure cognitive functioning and cognitive fatigability
Time Frame
Baseline
Title
Paced auditory serial addition test and symbol digit modality test
Description
to measure cognitive functioning and cognitive fatigability
Time Frame
week 5
Title
Motricity Index of dorsi flexors, knee extensors and hip flexors
Description
Muscle weakness
Time Frame
Baseline
Title
Motricity Index of dorsi flexors, knee extensors and hip flexors
Description
Muscle weakness
Time Frame
week 5
Title
Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts
Description
Spasticity
Time Frame
Baseline
Title
Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts
Description
Spasticity
Time Frame
week 5
Title
Scale for the assessment and rating of ataxia
Description
Ataxia
Time Frame
Baseline
Title
Scale for the assessment and rating of ataxia
Description
Ataxia
Time Frame
week 5
Title
Dynamic gait index
Description
Dynamic balance
Time Frame
Baseline
Title
Dynamic gait index
Description
Dynamic balance
Time Frame
week 5
Title
Time up and Go test
Description
balance
Time Frame
Baseline
Title
Time up and Go test
Description
balance
Time Frame
week 5
Title
Modified fatigue impact scale
Description
self-reported outcomes for fatigue
Time Frame
Baseline
Title
Modified fatigue impact scale
Description
self-reported outcomes for fatigue
Time Frame
week 5
Title
Barcelona music reward questionnaire
Description
experience of music reward
Time Frame
Baseline
Title
Barcelona music reward questionnaire
Description
experience of music reward
Time Frame
week 5
Title
Hospital anxiety and depression questionnaire
Description
anxiety and depression
Time Frame
Baseline
Title
Hospital anxiety and depression questionnaire
Description
anxiety and depression
Time Frame
week 5
Title
Activities-specific balance confidence scale
Description
self-reported outcome for activity and balance
Time Frame
Baseline
Title
Activities-specific balance confidence scale
Description
self-reported outcome for activity and balance
Time Frame
week 5
Title
Stroke rehabilitation motivation scale
Description
self-reported motivation questionnaire
Time Frame
Baseline
Title
Stroke rehabilitation motivation scale
Description
self-reported motivation questionnaire
Time Frame
week 5
Title
the Brunnel Music Rating Inventory-2
Description
self-reported music rating inventory
Time Frame
Baseline
Title
the Brunnel Music Rating Inventory-2
Description
self-reported music rating inventory
Time Frame
week 5
Title
credibility and expectations questionnaire
Description
self-reporting of credibility of the intervention.
Time Frame
week 5
Title
Pre and Post training sessions, 2x a week, 20 minutes for 4 weeks
Description
Before and after each training session Perceived cognitive and physical fatigue rated on a visual analogue scale Perceived motivation rated on a Likert scale
Time Frame
up to week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A diagnosis of MS if >1, no relapses >1 month, ability to walk for 12minutes, ability to walk independently on a treadmill walking speed between 0.8-1.2m/s. Exclusion Criteria: amusia, deafness, cognitive impairment hindering understanding of study instructions, 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, dr.
Phone
+32 11 26 93 71
Email
lousin.moumdjian@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Feyse, 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
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 9371
Email
lousine.moumdjian@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Ilse Lamers, dr.
Phone
+3211 28 69 39
Email
ilse.lamers@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Ilse Bosmans

12. IPD Sharing Statement

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Running Title: Walking to Music and in Silence on a Treadmill

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