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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03246217
Other study ID # #34521
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 20, 2017
Est. completion date September 5, 2019

Study information

Verified date September 2019
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 5, 2019
Est. primary completion date September 5, 2019
Accepts healthy volunteers No
Gender All
Age group 30 Years to 79 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Therapeutic Instrumental Music Performance
Participants will play a variety of instruments (acoustic and electronic) to facilitate retraining of everyday functional movements.
Therapeutic Performance with Sensory-Enhanced Motor Imagery
Participants will listen to a metronome set to their preferred pace for previously practised movements while engaging in motor imagery.
Therapeutic Performance with Motor Imagery
Participants will engage in motor imagery of previously practised movements.

Locations

Country Name City State
Canada Faculty of Music, University of Toronto Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes from baseline in Wolf Motor Function Test Measures upper extremity motor ability through timed and functional tasks. Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Primary Changes from baseline in Fugl-Meyer Assessment Upper Extremity Performance based measure assessing motor capacity. Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Secondary Motor Activity Log Individuals rate quality and amount of movement during daily functional tasks. Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Secondary Trunk Impairment Scale Assessment of upper trunk impairment using the upper trunk items of the Trunk Impairment Scale Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Secondary Multiple Affect Adjective Check List-Revised Measure of affective state Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Secondary General Self-Efficacy Scale Assessment of perceived self-efficacy Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Secondary Digit Span Assesses working memory and attention Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Secondary Trail Making Test Part B Assesses mental flexibility and processing speed Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
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