Clinical trial NCT04019912: The Novel Use of Treadmill Plus Music in MS Patients Gate Rehabilitation
Official title: A Randomized Trial on the Novel Use of Treadmill Plus Music in Multiple Sclerosis Patients With Gate Impairnent
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Interventional Study
Keywords: Gait rehabilitation
Rhythmic auditory stimulation
GaitTrainer3
Multiple sclerosis
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Ten-metre walking test
timeFrame: 3 months
measure: Timed up-and-go test
timeFrame: 3 months
Secondary outcomes:
measure: Gait Quality Index
timeFrame: 3 months
measure: Multiple Sclerosis Quality of Life-54
timeFrame: 3 months
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Neurolesi
state: Sicily
Study officials:
affiliation: IRCCS Centro Neurolesi
name: Rocco S Calabrò, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.