Multiple Sclerosis Clinical Trial
Official title:
Effect of Motor Entrainment to Auditory Cues and Music During Walking on Quality of Movement and Perceived Fatigue in Persons With Multiple Sclerosis (PwMS)
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 |
Verified date | August 2018 |
Source | Hasselt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | University of Ghent | Gent | |
Belgium | Nationaal Multiple Sclerose Center | Melsbroek | |
Belgium | Revalidatie & MS Centrum Overpelt | Overpelt |
Lead Sponsor | Collaborator |
---|---|
Hasselt University | National MS Center Melsbroek, Revalidatie and MS Centrum Overpelt, University Ghent |
Belgium,
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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