Music Therapy to Restore Motor Deficits After Stroke

NCT02208219 | Unknown

• 1 other identifier: CUB011995
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Motor deficits are common after stroke, being one of the major causes of disability in this population. Because of the impact that motor impairments have in the life of patients and the associated financial costs, it is a health care priority to develop effective and efficient treatments to restore motor deficits. Music-supported therapy (MST) has been recently developed to enhance the use of the affected extremity after stroke. 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.

Conditions

Stroke; Paresis

Keywords

Stroke; Paresis; Upper extremity; Motor deficits; Music Therapy; Neurorehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in the performance of movements with the paretic upper extremity assessed by the Action Research Arm Test (Carroll, 1965; Lyle, 1981).

  Baseline, after intervention, 6 months after intervention

Secondary Outcomes (21)

• Motor function: Change in the functional use of the paretic upper extremity using the Arm Paresis Score Test (Wade et al., 1983)

  Baseline, after intervention, 6 months after intervention

• Motor function: Change in motor performance in the paretic upper extremity assessed by in the Box and Block Test (Mathiowetz et al., 1985)

  Baseline, after intervention, 6 months after intervention

• Motor function: Change in motor performance in the paretic upper extremity assessed by the Nine Hole Pegboard Test (Parker et al., 1986)

  Baseline, after intervention, 6 months after intervention

• Motor function: Change in the functional use of the paretic upper extremity assessed by the Chedoke McMaster Stroke Impairment Inventory (Gowland et al., 1993)

  Baseline, after intervention, 6 months after intervention

• Motor function: Change in the physical motor properties of the paretic upper extremity assessed by in the Fugl-Meyer Assessment (Fugl-Meyer et al., 1975)

  Baseline, after intervention, 6 months after intervention

Other Outcomes (4)

• Mini Mental State Examination (Folstein et al., 1975)

  Baseline

• Verbal subtest from the Wechsler Adult Intelligence Scale III (Wechsler, 1997)

  Baseline

• Five Factor Personality Inventory (Hendriks et al., 1999)

  Baseline

Study Arms (3)

Music-supported Therapy (n=40)

EXPERIMENTAL

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).

Behavioral: Music-supported Therapy

home-based Music-supported Therapy(n=40)

EXPERIMENTAL

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).

Behavioral: home-based Music-supported Therapy

Conventional treatment (n=40)

ACTIVE COMPARATOR

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.

Behavioral: Conventional treatment

Interventions

Music-supported Therapy BEHAVIORAL

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.

Music-supported Therapy (n=40)

home-based Music-supported Therapy BEHAVIORAL

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.

home-based Music-supported Therapy(n=40)

Conventional treatment BEHAVIORAL

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.

Conventional treatment (n=40)

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Motor deficits of the upper limb after a first ever stroke
• 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

You may not qualify if:

• Inability to speak and understand the Spanish or Catalan language
• 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

Sponsors & Collaborators

• University of Barcelona: lead
• Institució Catalana de Recerca i Estudis Avançats: collaborator

Study Sites (1)

University of Barcelona; Hospitals del Mar i l'Esperança

Barcelona, Barcelona, 08024, Spain

RECRUITING

Related Links

• Webpage of the group of research Cognition and Brain Plasticity, University of Barcelona

MeSH Terms

Conditions

Stroke; Paresis; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoni Rodríguez-Fornells, PhD

  University of Barcelona, Intitut Català de Recerca i Estudis Avançats (ICREA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoni Rodríguez-Fornells, PhD

CONTACT

+34934021038; antoni.rodriguez@icrea.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: August 5, 2014
• Study Start: November 1, 2013
• Primary Completion: May 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 28, 2016

Record last verified: 2016-10

Locations

ES (1)