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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Trial on the Novel Use of Treadmill Plus Music in Multiple Sclerosis Patients With Gate Impairnent

Conditions
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Interventional Study

Intervention / Treatment
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* Other: Gait Training plus music
* Other: Traditional Gait Training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gait Training plus music<br>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. | Other: Gait Training plus music<br>* 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.<br>* Other names: GaitTrainer3;|
| Active Comparator: Traditional Gait Training<br>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. | Other: Traditional Gait Training<br>* The traditional training will be provided by a conventional treadmill.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gait rehabilitation, Rhythmic auditory stimulation, GaitTrainer3, Multiple sclerosis