4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / The Novel Use of Treadmill Plus Music in MS Patients Gate Rehabilitation (SMUSIC)

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

Study Description
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).

Condition or disease Intervention/treatment Phase
Interventional Study Other: Gait Training plus music Other: Traditional Gait Training Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The study uses a single-blinded study design.
Primary Purpose: Treatment
Official Title: A Randomized Trial on the Novel Use of Treadmill Plus Music in Multiple Sclerosis Patients With Gate Impairnent
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : May 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: 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.
 Other: 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.
Other Name: GaitTrainer3
Active Comparator: 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.
 Other: Traditional Gait Training
The traditional training will be provided by a conventional treadmill.
Outcome Measures
Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Gait Quality Index [ Time Frame: 3 months ]

    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.


  2. Multiple Sclerosis Quality of Life-54 [ Time Frame: 3 months ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Rocco S Calabrò, MD +3909060128166 salbro77@tiscali.it
Contact: Rossella Ciurleo +3909060128109 rosella.ciurleo@irccsme.it

Locations
Layout table for location information
Italy
IRCCS Neurolesi Recruiting
Messina, Sicily, Italy, 98124
Contact: Rocco S Calabrò         
Sponsors and Collaborators
IRCCS Centro Neurolesi "Bonino-Pulejo"
Investigators
Layout table for investigator information
Study Director: Rocco S Calabrò, MD IRCCS Centro Neurolesi
Tracking Information
First Submitted Date  ICMJE July 11, 2019
First Posted Date  ICMJE July 15, 2019
Last Update Posted Date February 21, 2020
Actual Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • Gait Quality Index [ Time Frame: 3 months ]
    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.
  • Multiple Sclerosis Quality of Life-54 [ Time Frame: 3 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Novel Use of Treadmill Plus Music in MS Patients Gate Rehabilitation
Official Title  ICMJE A Randomized Trial on the Novel Use of Treadmill Plus Music in Multiple Sclerosis Patients With Gate Impairnent
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
The study uses a single-blinded study design.
Primary Purpose: Treatment
Condition  ICMJE Interventional Study
Intervention  ICMJE
  • Other: 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.
    Other Name: GaitTrainer3
  • Other: Traditional Gait Training
    The traditional training will be provided by a conventional treadmill.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Other: Gait Training plus music
  • Active Comparator: 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.
    Intervention: Other: Traditional Gait Training
Publications *
  • Calabrò 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.
  • 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. Review.
  • 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.
  • 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 12, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rocco S Calabrò, MD +3909060128166 salbro77@tiscali.it
Contact: Rossella Ciurleo +3909060128109 rosella.ciurleo@irccsme.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04019912
Other Study ID Numbers  ICMJE IRCCSME 5/19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rocco Salvatore Calabrò, IRCCS Centro Neurolesi "Bonino-Pulejo"
Study Sponsor  ICMJE IRCCS Centro Neurolesi "Bonino-Pulejo"
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rocco S Calabrò, MD IRCCS Centro Neurolesi
PRS Account IRCCS Centro Neurolesi "Bonino-Pulejo"
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯