Multiple SclerosisNCT03281330
Effect of Motor Entrainment to Auditory Cues and Music During Walking on Quality of Movement and Perceived Fatigue in Persons With Multiple Sclerosis (PwMS)
An observational study of Multiple Sclerosis, run by Hasselt University at 3 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- auditory cues and music during walking
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 3 sitesBelgium
- Study dates
- 1 Feb 2017to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: persons with Multiple Sclerosis and healthy volonteers
Who may be able to join
- 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.
Who cannot join
- cognitive impairment hindering the understanding and execution of the experimental procedures
- pregnancy
- hearing impairment
- amusia
- beat deafness
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
University of Ghent
Ghent
Nationaal Multiple Sclerose Center
Melsbroek
Revalidatie & MS Centrum Overpelt
Overpelt
About this study
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.
- Conditions
- Multiple Sclerosis
- Being tested
- auditory cues and music during walking
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auditory cues and music during walkingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| persons with Multiple Sclerosis | Not described Receives: Behavioral: auditory cues and music during walking | |
| Healthy controls | Not described Receives: Behavioral: auditory cues and music during walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: week 3
Secondary outcomes (8)
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'
Measured: 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'
Measured: 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'
Measured: 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'
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Feb 2017
- Primary completion30 May 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, Revalidatie & MS Centrum Overpelt, National MS Center Melsbroek
- Responsible party
- Principal investigator, Peter Feys, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281330
- Sponsor's protocol ID
- B67021629797
- Status last verified
- Aug 2018
- First submitted
- 11 Sep 2017
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03281330
- Acronym / sponsor ID
- B67021629797
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- University Ghent, Revalidatie & MS Centrum Overpelt, National MS Center Melsbroek
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| persons with Multiple Sclerosis | – | Behavioral: auditory cues and music during walking |
| Healthy controls | – | Behavioral: auditory cues and music during walking |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- persons with Multiple Sclerosis and healthy volonteers
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- cognitive impairment hindering the understanding and execution of the experimental procedures
- pregnancy
- hearing impairment
- amusia
- beat deafness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auditory cues and music during walkingthe effect of different conditions of auditory cueing and music on walking quality and perceived fatigue in persons with multiple sclerosis compared to healthy controls | Behavioural | Healthy controls, persons with Multiple Sclerosis |
Primary outcome
Spatio-temporal parameters of gait
Time frame: day 1
Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.
Spatio-temporal parameters of gait
Time frame: week 1
Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.
Spatio-temporal parameters of gait
Time frame: week 2
Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.
Spatio-temporal parameters of gait
Time frame: week 3
Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.
Parameter's of sychronisation
Time frame: day 1
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
Parameter's of sychronisation
Time frame: week 1
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
Parameter's of sychronisation
Time frame: week 2
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
Parameter's of sychronisation
Time frame: week 3
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
8 secondary outcomes
subjective physical /mental fatigue
Time frame: day 1
subjective physical /mental fatigue
Time frame: week 1
subjective physical /mental fatigue
Time frame: week 2
physical /mental fatigue
Time frame: week 3
motivation
Time frame: day 1
motivation
Time frame: week 1
motivation
Time frame: week 2
motivation
Time frame: week 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Hasselt University at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatio-temporal parameters of gait (time frame: day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.