Multiple SclerosisNCT04856345
Running Title: Walking to Music and in Silence on a Treadmill
A study testing Walking with music with synchronisation, Walking with music without synchronisation and walking without music in people with Multiple Sclerosis, run by Hasselt University at 1 site in Belgium.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Walking with music with synchronisation, Walking with music without synchronisation and walking without music
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Jan 2021to 31 Dec 2023
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- amusia,
- deafness,
- cognitive impairment hindering understanding of study instructions,
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Walking with music with synchronisation, Walking with music without synchronisation, walking without music
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking with music with synchronisationOther
Walking with music than one can synch to
Walking with music without synchronisationOther
Walking with music than one cannot synch to
walking without musicOther
Walking without music
| Study group | Role | What they receive |
|---|---|---|
| Music with synchronising | Experimental | walking to music that one can synchronise to Receives: Other: Walking with music with synchronisation |
| Music without synchronising | Active comparator | walking to music that one cannot synchronise to Receives: Other: Walking with music without synchronisation |
| No music | Sham comparator | walking without music. Receives: Other: walking without music |
What is being measured
The primary outcome is the main question the study is designed to answer.
12- item multiple sclerosis walking scale
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.
Measured: Baseline
12- item multiple sclerosis walking scale
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.
Measured: week 5
6 minutes walking test to calculate the distance walking Index
impact of MS on walking
Measured: Baseline
6 minutes walking test to calculate the distance walking Index
impact of MS on walking
Measured: week 5
12 minute walking with sensors
gait dynamics and pattern - detrended fluctuation analysis and spatio-temporal parameters
Measured: Baseline
12 minute walking with sensors
gait dynamics and pattern - detrended fluctuation analysis and spatio-temporal parameters
Measured: week 5
Secondary outcomes (26)
Paced auditory serial addition test and symbol digit modality test
to measure cognitive functioning and cognitive fatigability
Measured: Baseline
Paced auditory serial addition test and symbol digit modality test
to measure cognitive functioning and cognitive fatigability
Measured: week 5
Motricity Index of dorsi flexors, knee extensors and hip flexors
Muscle weakness
Measured: Baseline
Motricity Index of dorsi flexors, knee extensors and hip flexors
Muscle weakness
Measured: week 5
Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts
Spasticity
Measured: Baseline
Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts
Spasticity
Measured: week 5
Scale for the assessment and rating of ataxia
Ataxia
Measured: Baseline
Scale for the assessment and rating of ataxia
Ataxia
Measured: week 5
Dynamic gait index
Dynamic balance
Measured: Baseline
Dynamic gait index
Dynamic balance
Measured: week 5
Time up and Go test
balance
Measured: Baseline
Time up and Go test
balance
Measured: week 5
Modified fatigue impact scale
self-reported outcomes for fatigue
Measured: Baseline
Modified fatigue impact scale
self-reported outcomes for fatigue
Measured: week 5
Barcelona music reward questionnaire
experience of music reward
Measured: Baseline
Barcelona music reward questionnaire
experience of music reward
Measured: week 5
Hospital anxiety and depression questionnaire
anxiety and depression
Measured: Baseline
Hospital anxiety and depression questionnaire
anxiety and depression
Measured: week 5
Activities-specific balance confidence scale
self-reported outcome for activity and balance
Measured: Baseline
Activities-specific balance confidence scale
self-reported outcome for activity and balance
Measured: week 5
Stroke rehabilitation motivation scale
self-reported motivation questionnaire
Measured: Baseline
Stroke rehabilitation motivation scale
self-reported motivation questionnaire
Measured: week 5
the Brunnel Music Rating Inventory-2
self-reported music rating inventory
Measured: Baseline
the Brunnel Music Rating Inventory-2
self-reported music rating inventory
Measured: week 5
credibility and expectations questionnaire
self-reporting of credibility of the intervention.
Measured: week 5
Pre and Post training sessions, 2x a week, 20 minutes for 4 weeks
Before and after each training session
- Perceived cognitive and physical fatigue rated on a visual analogue scale
- Perceived motivation rated on a Likert scale
Measured: up to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start22 Jan 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Revalidatie & MS Centrum Overpelt
- Responsible party
- Principal investigator, Peter Feys, Hasselt University
- Investigators
- Peter Feyse, prof. dr., Principal investigator, Hasselt UniversityLousin Moumdjian, dr., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856345
- Sponsor's protocol ID
- B1152020000021
- Status last verified
- Apr 2024
- First submitted
- 2 Feb 2021
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04856345
- Acronym / sponsor ID
- B1152020000021
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Revalidatie & MS Centrum Overpelt
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 23 Apr 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Music with synchronising | Experimental | Other: Walking with music with synchronisationwalking to music that one can synchronise to |
| Music without synchronising | Active comparator | Other: Walking with music without synchronisationwalking to music that one cannot synchronise to |
| No music | Sham comparator | Other: walking without musicwalking without music. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- amusia,
- deafness,
- cognitive impairment hindering understanding of study instructions,
- pregnancy.
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 |
|---|---|---|
| Walking with music with synchronisationWalking with music than one can synch to | Other | Music with synchronising |
| Walking with music without synchronisationWalking with music than one cannot synch to | Other | Music without synchronising |
| walking without musicWalking without music | Other | No music |
Primary outcome
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.
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.
6 minutes walking test to calculate the distance walking Index
Time frame: Baseline
impact of MS on walking
6 minutes walking test to calculate the distance walking Index
Time frame: week 5
impact of MS on walking
12 minute walking with sensors
Time frame: Baseline
gait dynamics and pattern - detrended fluctuation analysis and spatio-temporal parameters
12 minute walking with sensors
Time frame: week 5
gait dynamics and pattern - detrended fluctuation analysis and spatio-temporal parameters
26 secondary outcomes
Paced auditory serial addition test and symbol digit modality test
Time frame: Baseline
Paced auditory serial addition test and symbol digit modality test
Time frame: week 5
Motricity Index of dorsi flexors, knee extensors and hip flexors
Time frame: Baseline
Motricity Index of dorsi flexors, knee extensors and hip flexors
Time frame: week 5
Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts
Time frame: Baseline
Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts
Time frame: week 5
Scale for the assessment and rating of ataxia
Time frame: Baseline
Scale for the assessment and rating of ataxia
Time frame: week 5
Dynamic gait index
Time frame: Baseline
Dynamic gait index
Time frame: week 5
Time up and Go test
Time frame: Baseline
Time up and Go test
Time frame: week 5
Modified fatigue impact scale
Time frame: Baseline
Modified fatigue impact scale
Time frame: week 5
Barcelona music reward questionnaire
Time frame: Baseline
Barcelona music reward questionnaire
Time frame: week 5
Hospital anxiety and depression questionnaire
Time frame: Baseline
Hospital anxiety and depression questionnaire
Time frame: week 5
Activities-specific balance confidence scale
Time frame: Baseline
Activities-specific balance confidence scale
Time frame: week 5
Stroke rehabilitation motivation scale
Time frame: Baseline
Stroke rehabilitation motivation scale
Time frame: week 5
the Brunnel Music Rating Inventory-2
Time frame: Baseline
the Brunnel Music Rating Inventory-2
Time frame: week 5
credibility and expectations questionnaire
Time frame: week 5
Pre and Post training sessions, 2x a week, 20 minutes for 4 weeks
Time frame: up to week 4
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 25 Apr 2024.
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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.
Peter Feyse, prof. dr. principal investigator
Hasselt University
Lousin Moumdjian, dr. study chair
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking with music with synchronisation, Walking with music without synchronisation and walking without music in people with Multiple Sclerosis, run by Hasselt University at 1 site 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 5 inclusion and 4 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 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
12- item multiple sclerosis walking scale (time frame: Baseline). The study lists 6 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 25 Apr 2024.