Study Results
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Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2013-11-30
2017-07-31
Brief Summary
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In the present project, a new multidisciplinary approach (neurology, neuropsychology, music and cognitive neurosciences) will be undertaken in order to investigate the effectiveness of MST as a neurorehabilitation technique to restore the motor function in stroke patients. In addition, the complex pattern of reorganization of the sensorimotor system will be studied in order to provide information about the physiological mechanisms underlying the neurorehabilitation process.
A randomized controlled trial is proposed to compare for first time the effectiveness of MST (at the hospital and at home) compared to conventional treatment in subacute stroke patients suffering from motor deficits. Our hypothesis is that patients will experience a large improvement in the functional use of the affected arm due to the implementation of the MST program when compared to conventional treatment. We also expect to observe improvements in cognitive functions, mood and quality of life. Besides, we hypothesize that these amelioration in motor and cognitive domains will be accompanied by neuroplastic changes in the sensorimotor cortex and corticospinal tract.
Detailed Description
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In addition to the economic cost of medical treatments once the stroke has occurred, the ability of patients who are on working age to contribute to the society through the development of a remunerable occupation are clearly disrupted. Thus, there is a large cost in the maintenance of patients that cannot recover their motor function successfully. In this regard, stroke is an important health care priority due to direct (medical) and indirect (i.e. unemployment and loss of autonomy) costs.
Relevant findings in the medical acute management of stroke (i.e. minimization of complications, treatment optimization, thrombosis and standardized stroke units in hospitals) have been made. However, there is still little scientific evidence in the field of neurorehabilitation that clearly support the application of certain therapies that are used in several centres. Thus, it is extremely important to investigate motor rehabilitation therapies to provide evidence for clinicians of their effectiveness.
One of the approaches is to validate therapies that could promote brain plasticity, the ability whereby the brain changes its structure, functions and connections. Brain plasticity can occur spontaneously after the lesion, but it is also found during and after learning. Many consistent studies have demonstrated brain plasticity at cortical and subcortical levels due to motor skill learning in healthy subjects. Thus, interventions implying acquisition of new motor skills could be a good approach to promote the recovery of motor functions in stroke patients. An example of a motor skill involving fine hand movements is musical instrument playing, an activity with is unique and request complex demands for the central nervous system. Interactions between the auditory and motor systems are established during music performance as the sound of the instrument is processed and is postulated to be used to readjust movements. Furthermore, musical training has been proved to lead structural and functional changes in motor-related areas.
Recently, Schneider and colleagues developed a new neurorehabilitation tool to restore motor deficits after a stroke: the Music-supported Therapy (MST). In this therapy, patients are trained to play a MIDI-piano and an electronic drum to train fine and gross movements, respectively. Studies in acute and chronic stages have demonstrated that patients improve their motor function due to the therapy and that those changes are accompanied by brain plasticity. However, until now, no clear evidence exist of the advantage of this therapy (MST) compared to conventional therapy provided in hospital in subacute patients. Besides, no previous study has directly compared the changes observed in the brain in acute stroke patients using functional and structural neuroimaging after MT when compared to conventional or standard therapy.
We propose a multicentre randomized controlled trial to test the benefits of MST compared to conventional treatment in subacute stroke patients with motor deficits. In this study, 3 groups of treatment are established (MST training at the hospital, MST training at home and Conventional Treatment). Participants from all groups will be evaluated before and after the treatment to asses motor and cognitive functions, emotional status, quality of life and the brain plasticity associated with the treatment assessed with neuroimaging techniques. A follow-up evaluation will also be performed to assess if improvements are maintained within time.
The underlying hypothesis is that music therapy, which requires learning to play an instrument, will indirectly boost the neuroplasticity of the affected sensorimotor cortex in stroke patients due to the recruitment of audio-motor premotor circuits in the brain, necessary to play an instrument and for integrating auditory and motor aspects of music playing.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Music-supported Therapy (n=40)
Participants in this group will receive a Music-supported Therapy training at the Hospital during 1 month in addition to the standard rehabilitation program offered by the Public Health System in the Hospital, which comprises 2 hours of treatment per day (1 session of 1 hour of Occupational Therapy and 1 session of 1 hour of Physiotherapy).
Music-supported Therapy
A Music-supported Therapy training will be provided to participants in the hospital during 4 weeks (5 sessions per week, 30 min per session). In this treatment, two different musical instruments will be used: a MIDI-piano and an electronic drum set to train fine and gross movements of the affected hand, respectively. Exercises will follow a modular therapy regime with stepwise increase of complexity in the number of tones to perform, velocity, order of playing, and fingers used for playing. Each exercise will be first played by the experimenter and will be subsequently repeated by the patient.
home-based Music-supported Therapy(n=40)
Participants in this group will receive a Music-supported Therapy training at home during 1 month in addition to the standard rehabilitation program offered by the Public Health System in the Hospital, which comprises 2 hours of treatment per day (1 session of 1 hour of Occupational Therapy and 1 session of 1 hour of Physiotherapy).
home-based Music-supported Therapy
A Music-supported Therapy training at home will be provided to participants during 4 weeks (5 sessions per week, 30 min per session). Patients will play a portable roll-up MIDI-piano at home connected to the Synthesia LLC software. This software displays visual stimuli across a virtual piano on the computer screen which are served as cues to press the correct piano keys. A modular regime with stepwise increase in difficulty will be set in the program. With the aim to reinforce the training and solve problems that could appear at home, once per week patients will carry out the MST session in the hospital with the therapist. During this visit, each patient will complement his/her training with the electronic drum set and in order to train gross movements.
Conventional treatment (n=40)
Participants in this group will receive the standard rehabilitation program offered by the Public Health System in the Hospital, which comprises 2 hours of treatment per day (1 session of 1 hour of Occupational Therapy and 1 session of 1 hour of Physiotherapy). In order to balance the number of treatment hours between arms, this group will receive extra time of Conventional Treatment during 1 month.
Conventional treatment
This intervention comprises intensive training of the affected upper extremity during 4 weeks (5 sessions per week, 30 min per session). The conventional therapy program corresponds to standard therapies, prescribed by attending neurologists and adapted to the needs of every individual patient. Patients will receive intensive training on fine and gross movements of the affected upper extremity. A physical and occupational therapist will provide multiple exercises from the following options:
* Passive mobilization: controlled manipulation of movements to release a joint.
* Stretch and progressive resistance training.
* Task-specific training: reaching and manipulation of different objects.
* Intense physical training: repetition of sequence of movements.
Interventions
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Music-supported Therapy
A Music-supported Therapy training will be provided to participants in the hospital during 4 weeks (5 sessions per week, 30 min per session). In this treatment, two different musical instruments will be used: a MIDI-piano and an electronic drum set to train fine and gross movements of the affected hand, respectively. Exercises will follow a modular therapy regime with stepwise increase of complexity in the number of tones to perform, velocity, order of playing, and fingers used for playing. Each exercise will be first played by the experimenter and will be subsequently repeated by the patient.
home-based Music-supported Therapy
A Music-supported Therapy training at home will be provided to participants during 4 weeks (5 sessions per week, 30 min per session). Patients will play a portable roll-up MIDI-piano at home connected to the Synthesia LLC software. This software displays visual stimuli across a virtual piano on the computer screen which are served as cues to press the correct piano keys. A modular regime with stepwise increase in difficulty will be set in the program. With the aim to reinforce the training and solve problems that could appear at home, once per week patients will carry out the MST session in the hospital with the therapist. During this visit, each patient will complement his/her training with the electronic drum set and in order to train gross movements.
Conventional treatment
This intervention comprises intensive training of the affected upper extremity during 4 weeks (5 sessions per week, 30 min per session). The conventional therapy program corresponds to standard therapies, prescribed by attending neurologists and adapted to the needs of every individual patient. Patients will receive intensive training on fine and gross movements of the affected upper extremity. A physical and occupational therapist will provide multiple exercises from the following options:
* Passive mobilization: controlled manipulation of movements to release a joint.
* Stretch and progressive resistance training.
* Task-specific training: reaching and manipulation of different objects.
* Intense physical training: repetition of sequence of movements.
Eligibility Criteria
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Inclusion Criteria
* A minimum punctuation of 11 in the subtest from the Motricity Index and Trunk Control Test which evaluates grip and pinch
* Less than 6 months from stroke
* Age between 30 and 75 years
* Right-handed
Exclusion Criteria
* Major cognitive impairment affecting comprehension
* Neurological or psychiatric co-morbidity
* Substance abuse
* Formal musical education (i.e. professional musicians)
* Metallic implants incompatible with neuroimaging assessment
Withdrawal from the study:
* Voluntary withdrawal of consent
* A new episode of stroke during the participation in the study
30 Years
75 Years
ALL
No
Sponsors
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Institució Catalana de Recerca i Estudis Avançats
UNKNOWN
University of Barcelona
OTHER
Responsible Party
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Antoni Rodriguez Fornells
PhD
Principal Investigators
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Antoni Rodríguez-Fornells, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Barcelona, Intitut Català de Recerca i Estudis Avançats (ICREA)
Locations
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University of Barcelona; Hospitals del Mar i l'Esperança
Barcelona, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Antoni Rodríguez-Fornells, PhD
Role: primary
Related Links
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Webpage of the group of research Cognition and Brain Plasticity, University of Barcelona
Other Identifiers
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CUB011995
Identifier Type: -
Identifier Source: org_study_id