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Completed

NCT Number: NCT03246217

Therapeutic Instrumental Music Performance With Sensory-Enhanced Motor Imagery in Chronic Post-Stroke Rehabilitation

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

30 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Music, University of Toronto

Toronto, Ontario, M5S2C5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapeutic Instrumental Music Performance

Behavioral

Participants will play a variety of instruments (acoustic and electronic) to facilitate retraining of everyday functional movements.

Therapeutic Performance with Sensory-Enhanced Motor Imagery

Behavioral

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

Behavioral

Participants will engage in motor imagery of previously practised movements.

Primary outcomes

  1. Changes from baseline in Wolf Motor Function Test

    Time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks

    Measures upper extremity motor ability through timed and functional tasks.

  2. Changes from baseline in Fugl-Meyer Assessment Upper Extremity

    Time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks

    Performance based measure assessing motor capacity.

Secondary outcomes

  1. Motor Activity Log

    Time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks

    Individuals rate quality and amount of movement during daily functional tasks.

  2. Trunk Impairment Scale

    Time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks

    Assessment of upper trunk impairment using the upper trunk items of the Trunk Impairment Scale

  3. Multiple Affect Adjective Check List-Revised

    Time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks

    Measure of affective state

  4. General Self-Efficacy Scale

    Time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks

    Assessment of perceived self-efficacy

  5. Digit Span

    Time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks

    Assesses working memory and attention

  6. Trail Making Test Part B

    Time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks

    Assesses mental flexibility and processing speed

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Official study title

Efficacy of Therapeutic Instrumental Music Performance With Sensory-Enhanced Motor Imagery in Improving Therapeutic Outcomes for Individuals With Chronic Post-Stroke Hemiparesis

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 11, 2017
Registry last updated
Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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