Clinical trial NCT03246217: Therapeutic Instrumental Music Performance With Sensory-Enhanced Motor Imagery in Chronic Post-Stroke Rehabilitation
Official title: Efficacy of Therapeutic Instrumental Music Performance With Sensory-Enhanced Motor Imagery in Improving Therapeutic Outcomes for Individuals With Chronic Post-Stroke Hemiparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from baseline in Wolf Motor Function Test
timeFrame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
measure: Changes from baseline in Fugl-Meyer Assessment Upper Extremity
timeFrame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Secondary outcomes:
measure: Motor Activity Log
timeFrame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
measure: Trunk Impairment Scale
timeFrame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
measure: Multiple Affect Adjective Check List-Revised
timeFrame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
measure: General Self-Efficacy Scale
timeFrame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
measure: Digit Span
timeFrame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
measure: Trail Making Test Part B
timeFrame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Faculty of Music, University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Michael Thaut, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loria T, de Grosbois J, Haire C, Vuong V, Schaffert N, Tremblay L, Thaut MH. Music-based intervention drives paretic limb acceleration into intentional movement frequencies in chronic stroke rehabilitation. Front Rehabil Sci. 2022 Oct 3;3:989810. doi: 10.3389/fresc.2022.989810. eCollection 2022.