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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Therapeutic Instrumental Music Performance
Therapeutic Performance with Sensory-Enhanced Motor Imagery
Therapeutic Performance with Motor Imagery
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

30 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Music, University of Toronto

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Therapeutic Instrumental Music Performance

Therapeutic Performance with Sensory-Enhanced Motor Imagery

Therapeutic Performance with Motor Imagery

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Changes from baseline in Wolf Motor Function Test
Measures upper extremity motor ability through timed and functional tasks.
Changes from baseline in Fugl-Meyer Assessment Upper Extremity
Performance based measure assessing motor capacity.

Secondary Outcome Measures

Motor Activity Log
Individuals rate quality and amount of movement during daily functional tasks.
Trunk Impairment Scale
Assessment of upper trunk impairment using the upper trunk items of the Trunk Impairment Scale
Multiple Affect Adjective Check List-Revised
Measure of affective state
General Self-Efficacy Scale
Assessment of perceived self-efficacy
Digit Span
Assesses working memory and attention
Trail Making Test Part B
Assesses mental flexibility and processing speed

Full Information

First Posted
August 7, 2017
Last Updated
September 11, 2019
Sponsor
University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03246217
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 20, 2017 (Actual)
Primary Completion Date
September 5, 2019 (Actual)
Study Completion Date
September 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Instrumental Music Performance
Arm Type
Experimental
Arm Description
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.
Arm Title
Therapeutic Performance with Sensory-Enhanced Motor Imagery
Arm Type
Experimental
Arm Description
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.
Arm Title
Therapeutic Performance with Motor Imagery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic Instrumental Music Performance
Intervention Description
Participants will play a variety of instruments (acoustic and electronic) to facilitate retraining of everyday functional movements.
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic Performance with Sensory-Enhanced Motor Imagery
Intervention Description
Participants will listen to a metronome set to their preferred pace for previously practised movements while engaging in motor imagery.
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic Performance with Motor Imagery
Intervention Description
Participants will engage in motor imagery of previously practised movements.
Primary Outcome Measure Information:
Title
Changes from baseline in Wolf Motor Function Test
Description
Measures upper extremity motor ability through timed and functional tasks.
Time Frame
Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Title
Changes from baseline in Fugl-Meyer Assessment Upper Extremity
Description
Performance based measure assessing motor capacity.
Time Frame
Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Secondary Outcome Measure Information:
Title
Motor Activity Log
Description
Individuals rate quality and amount of movement during daily functional tasks.
Time Frame
Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Title
Trunk Impairment Scale
Description
Assessment of upper trunk impairment using the upper trunk items of the Trunk Impairment Scale
Time Frame
Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Title
Multiple Affect Adjective Check List-Revised
Description
Measure of affective state
Time Frame
Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Title
General Self-Efficacy Scale
Description
Assessment of perceived self-efficacy
Time Frame
Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Title
Digit Span
Description
Assesses working memory and attention
Time Frame
Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Title
Trail Making Test Part B
Description
Assesses mental flexibility and processing speed
Time Frame
Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Thaut, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Music, University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S2C5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36262914
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.
Results Reference
derived

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

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