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Clinical Trials/NCT04019912
NCT04019912
Unknown
Not Applicable

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

IRCCS Centro Neurolesi "Bonino-Pulejo"1 site in 1 country40 target enrollmentOctober 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Interventional Study
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
Enrollment
40
Locations
1
Primary Endpoint
Ten-metre walking test
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2019
End Date
May 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rocco Salvatore Calabrò

Medical Director, Neurologist

IRCCS Centro Neurolesi "Bonino-Pulejo"

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Gait Quality Index(3 months)
  • Multiple Sclerosis Quality of Life-54(3 months)

Study Sites (1)

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