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

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ClinicalTrials.gov Identifier: NCT04856345
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
Sponsor:
Collaborator:
Revalidatie & MS Centrum Overpelt
Information provided by (Responsible Party):
Peter Feys, Hasselt University

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Walking with music with synchronisation Other: Walking with music without synchronisation Other: walking without music Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 22, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Music with synchronising
walking to music that one can synchronise to
Other: Walking with music with synchronisation
Walking with music than one can synch to

Active Comparator: Music without synchronising
walking to music that one cannot synchronise to
Other: Walking with music without synchronisation
Walking with music than one cannot synch to

Sham Comparator: No music
walking without music.
Other: walking without music
Walking without music




Primary Outcome Measures :
  1. 12- item multiple sclerosis walking scale [ Time Frame: Baseline ]
    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.

  2. 12- item multiple sclerosis walking scale [ Time Frame: week 5 ]
    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.

  3. 6 minutes walking test to calculate the distance walking Index [ Time Frame: Baseline ]
    impact of MS on walking

  4. 6 minutes walking test to calculate the distance walking Index [ Time Frame: week 5 ]
    impact of MS on walking

  5. 12 minute walking with sensors [ Time Frame: Baseline ]
    gait dynamics and pattern - detrended fluctuation analysis and spatio-temporal parameters

  6. 12 minute walking with sensors [ Time Frame: week 5 ]
    gait dynamics and pattern - detrended fluctuation analysis and spatio-temporal parameters


Secondary Outcome Measures :
  1. Paced auditory serial addition test and symbol digit modality test [ Time Frame: Baseline ]
    to measure cognitive functioning and cognitive fatigability

  2. Paced auditory serial addition test and symbol digit modality test [ Time Frame: week 5 ]
    to measure cognitive functioning and cognitive fatigability

  3. Motricity Index of dorsi flexors, knee extensors and hip flexors [ Time Frame: Baseline ]
    Muscle weakness

  4. Motricity Index of dorsi flexors, knee extensors and hip flexors [ Time Frame: week 5 ]
    Muscle weakness

  5. Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts [ Time Frame: Baseline ]
    Spasticity

  6. Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts [ Time Frame: week 5 ]
    Spasticity

  7. Scale for the assessment and rating of ataxia [ Time Frame: Baseline ]
    Ataxia

  8. Scale for the assessment and rating of ataxia [ Time Frame: week 5 ]
    Ataxia

  9. Dynamic gait index [ Time Frame: Baseline ]
    Dynamic balance

  10. Dynamic gait index [ Time Frame: week 5 ]
    Dynamic balance

  11. Time up and Go test [ Time Frame: Baseline ]
    balance

  12. Time up and Go test [ Time Frame: week 5 ]
    balance

  13. Modified fatigue impact scale [ Time Frame: Baseline ]
    self-reported outcomes for fatigue

  14. Modified fatigue impact scale [ Time Frame: week 5 ]
    self-reported outcomes for fatigue

  15. Barcelona music reward questionnaire [ Time Frame: Baseline ]
    experience of music reward

  16. Barcelona music reward questionnaire [ Time Frame: week 5 ]
    experience of music reward

  17. Hospital anxiety and depression questionnaire [ Time Frame: Baseline ]
    anxiety and depression

  18. Hospital anxiety and depression questionnaire [ Time Frame: week 5 ]
    anxiety and depression

  19. Activities-specific balance confidence scale [ Time Frame: Baseline ]
    self-reported outcome for activity and balance

  20. Activities-specific balance confidence scale [ Time Frame: week 5 ]
    self-reported outcome for activity and balance

  21. Stroke rehabilitation motivation scale [ Time Frame: Baseline ]
    self-reported motivation questionnaire

  22. Stroke rehabilitation motivation scale [ Time Frame: week 5 ]
    self-reported motivation questionnaire

  23. the Brunnel Music Rating Inventory-2 [ Time Frame: Baseline ]
    self-reported music rating inventory

  24. the Brunnel Music Rating Inventory-2 [ Time Frame: week 5 ]
    self-reported music rating inventory

  25. credibility and expectations questionnaire [ Time Frame: week 5 ]
    self-reporting of credibility of the intervention.

  26. Pre and Post training sessions, 2x a week, 20 minutes for 4 weeks [ Time Frame: up to week 4 ]

    Before and after each training session

    • Perceived cognitive and physical fatigue rated on a visual analogue scale
    • Perceived motivation rated on a Likert scale



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04856345


Contacts
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Contact: Peter Feys, prof. dr. +32 11 29 21 23 peter.feys@uhasselt.be
Contact: Lousin moumdjian, dr. +32 11 26 93 71 lousin.moumdjian@uhasselt.be

Locations
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Belgium
Noorderhart Revalidatie & MS centrum Recruiting
Overpelt, Belgium, 3900
Contact: Lousin moumdjian, dr.    +32 11 26 9371    lousine.moumdjian@uhasselt.be   
Contact: Ilse Lamers, dr.    +3211 28 69 39    ilse.lamers@uhasselt.be   
Sub-Investigator: Ilse Bosmans         
Sponsors and Collaborators
Hasselt University
Revalidatie & MS Centrum Overpelt
Investigators
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Principal Investigator: Peter Feyse, prof. dr. Hasselt University
Study Chair: Lousin Moumdjian, dr. Hasselt University
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Responsible Party: Peter Feys, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier: NCT04856345    
Other Study ID Numbers: B1152020000021
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases