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

Sponsor
Hasselt University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04856345
Collaborator
Revalidatie & MS Centrum Overpelt (Other)
30
1
3
23.3
1.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Walking with music with synchronisation
  • Other: Walking with music without synchronisation
  • Other: walking without music
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 22, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 12- item multiple sclerosis walking scale [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 [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 [Baseline]

    impact of MS on walking

  4. 6 minutes walking test to calculate the distance walking Index [week 5]

    impact of MS on walking

  5. 12 minute walking with sensors [Baseline]

    gait dynamics and pattern - detrended fluctuation analysis and spatio-temporal parameters

  6. 12 minute walking with sensors [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 [Baseline]

    to measure cognitive functioning and cognitive fatigability

  2. Paced auditory serial addition test and symbol digit modality test [week 5]

    to measure cognitive functioning and cognitive fatigability

  3. Motricity Index of dorsi flexors, knee extensors and hip flexors [Baseline]

    Muscle weakness

  4. Motricity Index of dorsi flexors, knee extensors and hip flexors [week 5]

    Muscle weakness

  5. Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts [Baseline]

    Spasticity

  6. Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts [week 5]

    Spasticity

  7. Scale for the assessment and rating of ataxia [Baseline]

    Ataxia

  8. Scale for the assessment and rating of ataxia [week 5]

    Ataxia

  9. Dynamic gait index [Baseline]

    Dynamic balance

  10. Dynamic gait index [week 5]

    Dynamic balance

  11. Time up and Go test [Baseline]

    balance

  12. Time up and Go test [week 5]

    balance

  13. Modified fatigue impact scale [Baseline]

    self-reported outcomes for fatigue

  14. Modified fatigue impact scale [week 5]

    self-reported outcomes for fatigue

  15. Barcelona music reward questionnaire [Baseline]

    experience of music reward

  16. Barcelona music reward questionnaire [week 5]

    experience of music reward

  17. Hospital anxiety and depression questionnaire [Baseline]

    anxiety and depression

  18. Hospital anxiety and depression questionnaire [week 5]

    anxiety and depression

  19. Activities-specific balance confidence scale [Baseline]

    self-reported outcome for activity and balance

  20. Activities-specific balance confidence scale [week 5]

    self-reported outcome for activity and balance

  21. Stroke rehabilitation motivation scale [Baseline]

    self-reported motivation questionnaire

  22. Stroke rehabilitation motivation scale [week 5]

    self-reported motivation questionnaire

  23. the Brunnel Music Rating Inventory-2 [Baseline]

    self-reported music rating inventory

  24. the Brunnel Music Rating Inventory-2 [week 5]

    self-reported music rating inventory

  25. credibility and expectations questionnaire [week 5]

    self-reporting of credibility of the intervention.

  26. Pre and Post training sessions, 2x a week, 20 minutes for 4 weeks [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Noorderhart Revalidatie & MS centrum Overpelt Belgium 3900

Sponsors and Collaborators

  • Hasselt University
  • Revalidatie & MS Centrum Overpelt

Investigators

  • Principal Investigator: Peter Feyse, prof. dr., Hasselt University
  • Study Chair: Lousin Moumdjian, dr., Hasselt University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peter Feys, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier:
NCT04856345
Other Study ID Numbers:
  • B1152020000021
First Posted:
Apr 23, 2021
Last Update Posted:
Apr 23, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 23, 2021