Skip to main content
OpenTrials
Completed

NCT Number: NCT04856345

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Noorderhart Revalidatie & MS centrum

Overpelt, 3900, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Walking with music with synchronisation

Other

Walking with music than one can synch to

Walking with music without synchronisation

Other

Walking with music than one cannot synch to

walking without music

Other

Walking without music

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Revalidatie & MS Centrum Overpelt

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 23, 2021
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.