Interventional StudySMUSICNCT04019912
The Novel Use of Treadmill Plus Music in MS Patients Gate Rehabilitation
A study testing Gait Training plus music and Traditional Gait Training in people with Interventional Study, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial summary
Multiple sclerosis (MS) is characterized by demyelination andaxonal loss of the central nervous system, which progressively results in neurologic dysfunction and is often accompanied by gaite limitations, reduced fitness, and increased risk of falls. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Interventional Study
- What is being tested?
- Gait Training plus music and Traditional Gait Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2019to May 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of relapsing remitting MS according to Polman criteria;
- presence of gait impairment;
- absence of auditory deficits;
- EDSS <4.5;
- absence of clinical and/or neuroradiological MS relapse in the 3 months before enrolment;
- stable therapy in the last 3 months.
Who cannot join
- presence of bone or joint disorders;
- history of severe cardiovascular, respiratory, auditory, and muscular-skeletal disease;
- other neurological conditions; and neurologic music therapy in the last 3 month;
- MS relapse in the 6 months before enrolment;
- Expanded Disability Status Scale (EDSS) > 4.5.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Neurolesi
Messina, Sicily, 98124
Rocco S Calabrò
About this study
Official title: A Randomized Trial on the Novel Use of Treadmill Plus Music in Multiple Sclerosis Patients With Gate Impairnent
Multiple sclerosis (MS) is characterized by demyelination andaxonal loss of the central nervous system, which progressively results in neurologic dysfunction and is often accompanied by gaite limitations, reduced fitness, and increased risk of falls. Traditional exercises such as treadmill walking orstationary cycling can often be perceived as boring, because theseexercises usually involve repetitive, continuous movements. In recents years the positive effect of the auditory stimulus in the recovery of gait difficulties has been demonstrated in Parkinson's disease, however this methodology on MS patients has been poorly investigated. In addiction the neurophysiological mechanisms by which coupling steps with external auditory cues improves gait remain partially unclear. For this reason, our purpose is to investigate whether patients with MS, compared to the control group, may have improvements in motor and psychological well-being, through training with devices that integrate motor training with musical stimuli (Gait trainer).
Read the detailed description
Although the number of studies and the extent of available evidence is greater in case of parkinsonism, there is also evidence of the effects of music-based interventions on supporting motor function and emotional well-being in people with multiple sclerosis. Interventions based on music can influence multiple functions. Recently it has been shown that coupling of auditory signals with motor training may be possible to form a rhythmic gait by dragging movement patterns, supporting the generation of better gait patterns; moreover, it can have effects on the rhythmic dragging; the commitment of automatic timing systems; movement planning, execution and learning; and an increase in motivation. Furthermore, this type of coupling has been shown to improve various gait parameters, including cadence, gait speed, stride length, gait time variability and pitch width.
The aim of our study is to evaluate the effectiveness of the treadmill training combined with RAS in terms of mobility, balance and gait parameters, patient's well-being.
- Conditions
- Interventional Study
- Being tested
- Gait Training plus music, Traditional Gait Training
- Keywords
- Gait rehabilitation, Rhythmic auditory stimulation, GaitTrainer3, Multiple sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait Training plus musicOther
Also called GaitTrainer3
GaitTrainer3 is a platform that integrates gait training via a treadmill and RAS. The device is indeed equipped with an instrumented deck that issues acoustic cues to determine the exact tempo and rhythm during gait training and visual real-time biofeedback to prompt patients to follow their gait pattern. In fact, the device provides online feedback, including step length, speed, and symmetry, to encourage patient progress and monitor patient performance. Patient footfalls were compared in real-time to the desired footfalls step by step and documented in a histogram.
Traditional Gait TrainingOther
The traditional training will be provided by a conventional treadmill.
| Study group | Role | What they receive |
|---|---|---|
| Gait Training plus music | Experimental | Patients will be randomly assigned to the rehabilitation group through gait trainer3 with Rhythmic Auditory Stimulation (RAS). All patients will undergo a complete clinical and neurophysiological evaluation at baseline. The training program consist of 45 minutes of treadmill training with RAS. The daily training program will be practiced once a day at the same time of day (from 9:00 am to 1:00 pm), five times a week for eight consecutive weeks. RAS treadmill sessions will be performed individually in the same position and under the supervision of physiotherapists with 2 years of RAS training. Receives: Other: Gait Training plus music |
| Traditional Gait Training | Active comparator | Patients will be randomly assigned to the non-Rhythmic Auditory Stimulation (RAS) treadmill walking group. All patients will undergo a complete clinical and neurophysiological evaluation at baseline.The daily training program consist of 45 minutes of conventional gait training using a non-RAS treadmill. The daily training program will be practiced once a day at the same time of day (from 9:00 am to 1:00 pm), five times a week for eight consecutive weeks. Non-RAS treadmill sessions will be performed individually in the same position and under the supervision of physiotherapists. Receives: Other: Traditional Gait Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ten-metre walking test
The 10 Metre Walk Test (10MWT) is a performance measure used to assess walking speed in metres per second over a short distance.
Measured: 3 months
Timed up-and-go test
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance
Measured: 3 months
Secondary outcomes (2)
Gait Quality Index
BTS GAITLAB supplies to the physician the quantitative information and objective data needed to identify and analyze walking and posture problems, load anomalies and muscle failure, which would not be measurable with normal clinical exams.
The digital synchronization of different analysis tools helps to simultaneously compare, frame by frame, the patient's movements of limbs and muscles and force distribution on the surface during movement.
Measured: 3 months
Multiple Sclerosis Quality of Life-54
The Multiple Sclerosis Quality of Life-54 (MSQOL-54) is a multidimensional health-related quality of life measure, assessing the perception of physical and mental well-being. The instrument is composed of 54 items concerning 12 subscales, which form two scales relating to the physical and mental well-being. The score of the physical function scales, perceptions of health, energy/fatigue, role-physical limitations, pain, sexual function, social function, health distress, is added and corrected to obtain a score on the MSQUOL PHYSICAL HEALTH scale: a score above 50.0 indicates physical well-being. The score of the health distress scale, overall quality of life, emotional well-being, role limitations - emotional, cognitive function is summed and corrected to obtain a score on the scale MSQUOL MENTAL HEALTH: a score above 50.0 indicates mental well-being. The administration time is about 11-18 minutes, it can be completed by an interviewer or by the patient.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start1 Oct 2019
- Primary completion30 Mar 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Interventional StudyStudies 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
- Model description
- The study is a parallel-group randomized clinical trial using a double-blind study design. The enrolled patients will be randomly assigned to the 2 groups using an automated computerized randomization program. Patients will be informed about the research and will be asked to fill in the informed consent form. The patient's basic characteristics (age, sex, duration of the illness, marital status and educational background) will be recorded. Randomization will be performed using a randomization list, so patients will be randomized in a 1:1 ratio in the intervention or control group. The randomization list is blind to anyone involved in informing potential study participants.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocco Salvatore Calabrò, IRCCS Centro Neurolesi Bonino Pulejo
- Investigators
- Rocco S Calabrò, MD, Study director, IRCCS Centro Neurolesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019912
- Sponsor's protocol ID
- IRCCSME 5/19
- Acronym
- SMUSIC
- Status last verified
- Feb 2020
- First submitted
- 11 Jul 2019
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Calabro RS, Naro A, Filoni S, Pullia M, Billeri L, Tomasello P, Portaro S, Di Lorenzo G, Tomaino C, Bramanti P. Walking to your right music: a randomized controlled trial on the novel use of treadmill plus music in Parkinson's disease. J Neuroeng Rehabil. 2019 Jun 7;16(1):68. doi: 10.1186/s12984-019-0533-9.
PubMed 31174570Shahraki M, Sohrabi M, Taheri Torbati HR, Nikkhah K, NaeimiKia M. Effect of rhythmic auditory stimulation on gait kinematic parameters of patients with multiple sclerosis. J Med Life. 2017 Jan-Mar;10(1):33-37.
PubMed 28255373Conklyn D, Stough D, Novak E, Paczak S, Chemali K, Bethoux F. A home-based walking program using rhythmic auditory stimulation improves gait performance in patients with multiple sclerosis: a pilot study. Neurorehabil Neural Repair. 2010 Nov-Dec;24(9):835-42. doi: 10.1177/1545968310372139. Epub 2010 Jul 19.
PubMed 20643882Ashoori A, Eagleman DM, Jankovic J. Effects of Auditory Rhythm and Music on Gait Disturbances in Parkinson's Disease. Front Neurol. 2015 Nov 11;6:234. doi: 10.3389/fneur.2015.00234. eCollection 2015.
PubMed 26617566
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial on the Novel Use of Treadmill Plus Music in Multiple Sclerosis Patients With Gate Impairnent
- ClinicalTrials.gov ID
- NCT04019912
- Acronym / sponsor ID
- SMUSIC / IRCCSME 5/19
- Conditions
- Interventional Study
- Keywords
- Gait rehabilitation, Rhythmic auditory stimulation, GaitTrainer3, Multiple sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Mar 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 15 Jul 2019 (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.
Multiple sclerosis (MS) is characterized by demyelination andaxonal loss of the central nervous system, which progressively results in neurologic dysfunction and is often accompanied by gaite limitations, reduced fitness, and increased risk of falls. Traditional exercises such as treadmill walking orstationary cycling can often be perceived as boring, because theseexercises usually involve repetitive, continuous movements. In recents years the positive effect of the auditory stimulus in the recovery of gait difficulties has been demonstrated in Parkinson's disease, however this methodology on MS patients has been poorly investigated. In addiction the neurophysiological mechanisms by which coupling steps with external auditory cues improves gait remain partially unclear. For this reason, our purpose is to investigate whether patients with MS, compared to the control group, may have improvements in motor and psychological well-being, through training with devices that integrate motor training with musical stimuli (Gait trainer).
Detailed description
Although the number of studies and the extent of available evidence is greater in case of parkinsonism, there is also evidence of the effects of music-based interventions on supporting motor function and emotional well-being in people with multiple sclerosis. Interventions based on music can influence multiple functions. Recently it has been shown that coupling of auditory signals with motor training may be possible to form a rhythmic gait by dragging movement patterns, supporting the generation of better gait patterns; moreover, it can have effects on the rhythmic dragging; the commitment of automatic timing systems; movement planning, execution and learning; and an increase in motivation. Furthermore, this type of coupling has been shown to improve various gait parameters, including cadence, gait speed, stride length, gait time variability and pitch width.
The aim of our study is to evaluate the effectiveness of the treadmill training combined with RAS in terms of mobility, balance and gait parameters, patient's well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a parallel-group randomized clinical trial using a double-blind study design. The enrolled patients will be randomly assigned to the 2 groups using an automated computerized randomization program. Patients will be informed about the research and will be asked to fill in the informed consent form. The patient's basic characteristics (age, sex, duration of the illness, marital status and educational background) will be recorded. Randomization will be performed using a randomization list, so patients will be randomized in a 1:1 ratio in the intervention or control group. The randomization list is blind to anyone involved in informing potential study participants.
| Arm | Type | Receives |
|---|---|---|
| Gait Training plus music | Experimental | Other: Gait Training plus musicPatients will be randomly assigned to the rehabilitation group through gait trainer3 with Rhythmic Auditory Stimulation (RAS). All patients will undergo a complete clinical and neurophysiological evaluation at baseline. The training program consist of 45 minutes of treadmill training with RAS. The daily training program will be practiced once a day at the same time of day (from 9:00 am to 1:00 pm), five times a week for eight consecutive weeks. RAS treadmill sessions will be performed individually in the same position and under the supervision of physiotherapists with 2 years of RAS training. |
| Traditional Gait Training | Active comparator | Other: Traditional Gait TrainingPatients will be randomly assigned to the non-Rhythmic Auditory Stimulation (RAS) treadmill walking group. All patients will undergo a complete clinical and neurophysiological evaluation at baseline.The daily training program consist of 45 minutes of conventional gait training using a non-RAS treadmill. The daily training program will be practiced once a day at the same time of day (from 9:00 am to 1:00 pm), five times a week for eight consecutive weeks. Non-RAS treadmill sessions will be performed individually in the same position and under the supervision of physiotherapists. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of relapsing remitting MS according to Polman criteria;
- presence of gait impairment;
- absence of auditory deficits;
- EDSS <4.5;
- absence of clinical and/or neuroradiological MS relapse in the 3 months before enrolment;
Key exclusion criteria (5 listed)
- presence of bone or joint disorders;
- history of severe cardiovascular, respiratory, auditory, and muscular-skeletal disease;
- other neurological conditions; and neurologic music therapy in the last 3 month;
- MS relapse in the 6 months before enrolment;
- Expanded Disability Status Scale (EDSS) > 4.5.
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 |
|---|---|---|
| Gait Training plus musicAlso: GaitTrainer3GaitTrainer3 is a platform that integrates gait training via a treadmill and RAS. The device is indeed equipped with an instrumented deck that issues acoustic cues to determine the exact tempo and rhythm during gait training and visual real-time biofeedback to prompt patients to follow their gait pattern. In fact, the device provides online feedback, including step length, speed, and symmetry, to encourage patient progress and monitor patient performance. Patient footfalls were compared in real-time to the desired footfalls step by step and documented in a histogram. | Other | Gait Training plus music |
| Traditional Gait TrainingThe traditional training will be provided by a conventional treadmill. | Other | Traditional Gait Training |
Primary outcome
Ten-metre walking test
Time frame: 3 months
The 10 Metre Walk Test (10MWT) is a performance measure used to assess walking speed in metres per second over a short distance.
Timed up-and-go test
Time frame: 3 months
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance
2 secondary outcomes
Gait Quality Index
Time frame: 3 months
Multiple Sclerosis Quality of Life-54
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Results publication: PubMed 31174570Calabro RS, Naro A, Filoni S, Pullia M, Billeri L, Tomasello P, Portaro S, Di Lorenzo G, Tomaino C, Bramanti P. Walking to your right music: a randomized controlled trial on the novel use of treadmill plus music in Parkinson's disease. J Neuroeng Rehabil. 2019 Jun 7;16(1):68. doi: 10.1186/s12984-019-0533-9.
- Results publication: PubMed 28255373Shahraki M, Sohrabi M, Taheri Torbati HR, Nikkhah K, NaeimiKia M. Effect of rhythmic auditory stimulation on gait kinematic parameters of patients with multiple sclerosis. J Med Life. 2017 Jan-Mar;10(1):33-37.
- Results publication: PubMed 20643882Conklyn D, Stough D, Novak E, Paczak S, Chemali K, Bethoux F. A home-based walking program using rhythmic auditory stimulation improves gait performance in patients with multiple sclerosis: a pilot study. Neurorehabil Neural Repair. 2010 Nov-Dec;24(9):835-42. doi: 10.1177/1545968310372139. Epub 2010 Jul 19.
- Results publication: PubMed 26617566Ashoori A, Eagleman DM, Jankovic J. Effects of Auditory Rhythm and Music on Gait Disturbances in Parkinson's Disease. Front Neurol. 2015 Nov 11;6:234. doi: 10.3389/fneur.2015.00234. eCollection 2015.
- Individual participant dataSharing planned: No
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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.
Rocco S Calabrò, MD study director
IRCCS Centro Neurolesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait Training plus music and Traditional Gait Training in people with Interventional Study, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
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 6 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: status not confirmed, as of the sponsor's last update on 21 Feb 2020. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rocco S Calabrò, MD (+3909060128166, salbro77@tiscali.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ten-metre walking test (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04019912, which also lists 4 linked publications.
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 21 Feb 2020.