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

NCT04019912 | Unknown

• 1 other identifier: IRCCSME 5/19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Interventional Study

Keywords

Gait rehabilitation; Rhythmic auditory stimulation; GaitTrainer3; Multiple sclerosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Gait Quality Index

  3 months

• Multiple Sclerosis Quality of Life-54

  3 months

Study Arms (2)

Gait Training plus music

EXPERIMENTAL

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

Traditional Gait Training

ACTIVE COMPARATOR

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

Interventions

Gait Training plus music 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.

Also known as: GaitTrainer3

Gait Training plus music

Traditional Gait Training OTHER

The traditional training will be provided by a conventional treadmill.

Traditional Gait Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Neurolesi

Messina, Sicily, 98124, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 31174570 RESULT

• 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.

  PMID: 28255373 RESULT

• 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.

  PMID: 20643882 RESULT

• 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.

  PMID: 26617566 RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rocco S Calabrò, MD

  IRCCS Centro Neurolesi

  STUDY DIRECTOR

Central Study Contacts

Rocco S Calabrò, MD

CONTACT

+3909060128166; salbro77@tiscali.it

Rossella Ciurleo

CONTACT

+3909060128109; rosella.ciurleo@irccsme.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study uses a single-blinded study design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Neurologist

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 15, 2019
• Study Start: October 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: May 1, 2020
• Last Updated: February 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)