The Novel Use of Treadmill Plus Music in MS Patients Gate Rehabilitation

NCT ID: NCT04019912

Last Updated: 2020-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-05-31

Brief 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. 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.

Conditions

Interventional Study

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Gait Training plus music

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.

Group Type: EXPERIMENTAL

Gait Training plus music

Intervention Type: OTHER

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 Training

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.

Group Type: ACTIVE_COMPARATOR

Traditional Gait Training

Intervention Type: OTHER

The traditional training will be provided by a conventional treadmill.

Interventions

Gait Training plus music

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.

Intervention Type: OTHER

Traditional Gait Training

The traditional training will be provided by a conventional treadmill.

Intervention Type: OTHER

Other Intervention Names

GaitTrainer3

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Centro Neurolesi Bonino Pulejo

OTHER

Sponsor Role: lead

Responsible Party

Rocco Salvatore Calabrò

Medical Director, Neurologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rocco S Calabrò, MD

Role: STUDY_DIRECTOR

IRCCS Centro Neurolesi

Locations

IRCCS Neurolesi

Messina, Sicily, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Rocco S Calabrò, MD

Role: CONTACT

salbro77@tiscali.it

+3909060128166

Rossella Ciurleo

Role: CONTACT

rosella.ciurleo@irccsme.it

+3909060128109

Facility Contacts

Rocco S Calabrò

Role: primary

References

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.

Reference Type: RESULT

PMID: 31174570 (View on PubMed)

Shahraki 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.

Reference Type: RESULT

PMID: 28255373 (View on PubMed)

Conklyn 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.

Reference Type: RESULT

PMID: 20643882 (View on PubMed)

Ashoori 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.

Reference Type: RESULT

PMID: 26617566 (View on PubMed)

Other Identifiers

IRCCSME 5/19

Identifier Type: -

Identifier Source: org_study_id