Effect of Motor Entrainment to Auditory Cues and Music During Walking on Quality of Movement and Perceived Fatigue in Persons With Multiple Sclerosis (PwMS)

The study investigates the effect of different conditions of auditory cueing and music on walking quality and perceived fatigue in persons with multiple sclerosis compared to healthy controls. The study extends over a four session period, each session lasting maximally 1h30 minutes The experimental conditions include participants walking to music and metronome (at different tempi) for 3minutes and 15 seconds per condition, with a rest period of 3 minutes in between each condition. Non-invasive equipment will be used. participants are equipped with sensors (watch-like straps at the wrists, ankles and across the chest) and are given wireless headphones.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: auditory cues and music during walking

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium
    • University of Ghent
  • Melsbroek, Belgium
    • Nationaal Multiple Sclerose Center
  • Overpelt, Belgium
    • Revalidatie & MS Centrum Overpelt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

persons with Multiple Sclerosis and healthy volonteers

Description

Inclusion Criteria:

• diagnosis of MS of >1 year,
• no relapse in the last 1 month,
• ability to walk for 12 minutes without interruption,
• an average usual walking speed between the range of 0.4 and 1.2 m/s.

Exclusion Criteria:

• cognitive impairment hindering the understanding and execution of the experimental procedures
• pregnancy
• hearing impairment
• amusia
• beat deafness

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy controls	Behavioral: auditory cues and music during walking; the effect of different conditions of auditory cueing and music on walking quality and perceived fatigue in persons with multiple sclerosis compared to healthy controls
persons with Multiple Sclerosis	Behavioral: auditory cues and music during walking; the effect of different conditions of auditory cueing and music on walking quality and perceived fatigue in persons with multiple sclerosis compared to healthy controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spatio-temporal parameters of gait	Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.	day 1
Spatio-temporal parameters of gait	Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.	week 1
Spatio-temporal parameters of gait	Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.	week 2
Spatio-temporal parameters of gait	Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.	week 3
Parameter's of sychronisation	Participants have two light ipods attached on their ankles- these are a part of the D-jogger system. The system is activated during the walking, and logs the synchronization parameters	day 1
Parameter's of sychronisation	Participants have two light ipods attached on their ankles- these are a part of the D-jogger system. The system is activated during the walking, and logs the synchronization parameters	week 1
Parameter's of sychronisation	Participants have two light ipods attached on their ankles- these are a part of the D-jogger system. The system is activated during the walking, and logs the synchronization parameters	week 2
Parameter's of sychronisation	Participants have two light ipods attached on their ankles- these are a part of the D-jogger system. The system is activated during the walking, and logs the synchronization parameters	week 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
subjective physical /mental fatigue	After each experimental condition, the participant is asked 'how tired do you feel in your body on a scale of 0 to 10, 0 being not tired at all and 10 being exhausted'	day 1
subjective physical /mental fatigue	After each experimental condition, the participant is asked 'how tired do you feel in your body on a scale of 0 to 10, 0 being not tired at all and 10 being exhausted'	week 1
subjective physical /mental fatigue	After each experimental condition, the participant is asked 'how tired do you feel in your body on a scale of 0 to 10, 0 being not tired at all and 10 being exhausted'	week 2
physical /mental fatigue	After each experimental condition, the participant is asked 'how tired do you feel in your body on a scale of 0 to 10, 0 being not tired at all and 10 being exhausted'	week 3
motivation	he participants is asked: 'how motivating was it to walk to the last particular stimuli (in the metronome condition)/Song (in the music condition) on a scale of 0-5. ) being not motivating at all and 5 being very motivating'.	day 1
motivation	he participants is asked: 'how motivating was it to walk to the last particular stimuli (in the metronome condition)/Song (in the music condition) on a scale of 0-5. ) being not motivating at all and 5 being very motivating'.	week 1
motivation	he participants is asked: 'how motivating was it to walk to the last particular stimuli (in the metronome condition)/Song (in the music condition) on a scale of 0-5. ) being not motivating at all and 5 being very motivating'.	week 2
motivation	he participants is asked: 'how motivating was it to walk to the last particular stimuli (in the metronome condition)/Song (in the music condition) on a scale of 0-5. ) being not motivating at all and 5 being very motivating'.	week 3

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: University Ghent; Revalidatie & MS Centrum Overpelt; National MS Center Melsbroek

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ACTUAL): May 30, 2018
• Study Completion (ACTUAL): June 30, 2018

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (ACTUAL): September 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 2, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: B67021629797

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No