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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03281330
Other study ID # B67021629797
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2017
Est. completion date June 30, 2018

Study information

Verified date August 2018
Source Hasselt University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 30, 2018
Est. primary completion date May 30, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Belgium University of Ghent Gent
Belgium Nationaal Multiple Sclerose Center Melsbroek
Belgium Revalidatie & MS Centrum Overpelt Overpelt

Sponsors (4)

Lead Sponsor Collaborator
Hasselt University National MS Center Melsbroek, Revalidatie and MS Centrum Overpelt, University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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