- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03246217
Therapeutic Instrumental Music Performance With Sensory-Enhanced Motor Imagery in Chronic Post-Stroke Rehabilitation
September 11, 2019 updated by: Catherine Haire, University of Toronto
Efficacy of Therapeutic Instrumental Music Performance With Sensory-Enhanced Motor Imagery in Improving Therapeutic Outcomes for Individuals With Chronic Post-Stroke Hemiparesis
Research has shown that music engages the brain bilaterally throughout cortical and subcortical regions, accessing extended sensorimotor, cognitive and affective networks.
This research explores the hypothesis that use of these shared neural networks allows neurologic music therapy interventions targeting upper extremity motor control to promote plasticity and functional improvements in persons recovering from a cerebrovascular accident.
The potential therapeutic benefits of these interventions on attentional processes and affective responding will also be examined.
Study Overview
Status
Completed
Conditions
Detailed Description
More individuals are surviving and living with the effects of stroke, a trend that is expected to continue.
Upper extremity limitations present a common, persistent challenge for stroke survivors, impacting quality of life.
In addition, links have been found between physical impairment and depression, and depression and stroke-induced cognitive impairment.
Music has been shown to exert multimodal effects on individuals and may be used as a mediating stimulus to promote therapeutic change.
Furthermore, motor imagery may enhance the effectiveness of upper extremity interventions by engaging the same brain areas that are active in physical movement.
The purpose of this study is to investigate the effects of therapeutic instrumental music performance and sensory-enhanced motor imagery on upper limb movement, affect and cognition following a stroke.
Participants will be assessed at two baselines, and randomly assigned to one of three intervention groups: therapeutic instrumental music performance, therapeutic instrumental music performance and sensory-enhanced motor imagery, or therapeutic instrumental music performance and motor imagery without sensory enhancement.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5S2C5
- Faculty of Music, University of Toronto
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- hemiparesis following a unilateral stroke (hemorrhagic or ischemic), sustained more than 6 months prior, with at least minimal volitional movement of the affected limb
- permission from a physician to participate in an upper extremity rehabilitation program, including confirmation that the following disorders are not present: rheumatoid arthritis, upper extremity fracture, apraxia, neuropathy, somatosensory impairment
- adequate language comprehension and neurocognitive function to understand and follow simple instructions
Exclusion Criteria:
- currently enrolled in an upper extremity rehabilitation program or another upper extremity study
- comorbid neurological disorder (e.g. multiple sclerosis, Parkinson's disease)
- evidence of perceptual or cognitive impairment; e.g., unilateral spatial neglect, significant hearing impairment, Montreal Cognitive Assessment score of 25 or less
- presence of aphasia
- injections for spasticity within three months of participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Therapeutic Instrumental Music Performance
Therapeutic Instrumental Music Performance is a Neurologic Music Therapy technique in which selection of instruments, spatial configurations and sequences for playing are designed to facilitate retraining of movement patterns used in everyday life.
Participants will receive nine individual forty-five minute sessions of Therapeutic Instrumental Music Performance, three sessions per week.
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Participants will play a variety of instruments (acoustic and electronic) to facilitate retraining of everyday functional movements.
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Experimental: Therapeutic Performance with Sensory-Enhanced Motor Imagery
Participants will receive nine individual sessions, three times per week: thirty minutes of Therapeutic Instrumental Music Performance, followed by fifteen minutes of sensory-enhanced motor imagery.
During sensory-enhanced motor imagery, participants will listen to a metronome set to their preferred pace for previously practised movements while engaging in motor imagery.
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Participants will play a variety of instruments (acoustic and electronic) to facilitate retraining of everyday functional movements.
Participants will listen to a metronome set to their preferred pace for previously practised movements while engaging in motor imagery.
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Experimental: Therapeutic Performance with Motor Imagery
Participants will receive nine individual sessions, three times per week: thirty minutes of Therapeutic Instrumental Music Performance, followed by fifteen minutes of motor imagery.
Motor imagery will involve mental practice of previous movement exercises.
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Participants will play a variety of instruments (acoustic and electronic) to facilitate retraining of everyday functional movements.
Participants will engage in motor imagery of previously practised movements.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes from baseline in Wolf Motor Function Test
Time Frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
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Measures upper extremity motor ability through timed and functional tasks.
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Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
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Changes from baseline in Fugl-Meyer Assessment Upper Extremity
Time Frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
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Performance based measure assessing motor capacity.
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Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Motor Activity Log
Time Frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
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Individuals rate quality and amount of movement during daily functional tasks.
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Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
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Trunk Impairment Scale
Time Frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
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Assessment of upper trunk impairment using the upper trunk items of the Trunk Impairment Scale
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Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
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Multiple Affect Adjective Check List-Revised
Time Frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
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Measure of affective state
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Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
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General Self-Efficacy Scale
Time Frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
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Assessment of perceived self-efficacy
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Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
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Digit Span
Time Frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
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Assesses working memory and attention
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Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
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Trail Making Test Part B
Time Frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
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Assesses mental flexibility and processing speed
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Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Thaut, PhD, University of Toronto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 20, 2017
Primary Completion (Actual)
September 5, 2019
Study Completion (Actual)
September 5, 2019
Study Registration Dates
First Submitted
August 7, 2017
First Submitted That Met QC Criteria
August 9, 2017
First Posted (Actual)
August 11, 2017
Study Record Updates
Last Update Posted (Actual)
September 16, 2019
Last Update Submitted That Met QC Criteria
September 11, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #34521
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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