NCT03246217

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2019

Completed
Last Updated

September 16, 2019

Status Verified

September 1, 2019

Enrollment Period

2.1 years

First QC Date

August 7, 2017

Last Update Submit

September 11, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • Motor Activity Log

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

  • Trunk Impairment Scale

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

  • Multiple Affect Adjective Check List-Revised

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

  • General Self-Efficacy Scale

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

  • Digit Span

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

  • +1 more secondary outcomes

Study Arms (3)

Therapeutic Instrumental Music Performance

EXPERIMENTAL

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.

Behavioral: Therapeutic Instrumental Music Performance

Therapeutic Performance with Sensory-Enhanced Motor Imagery

EXPERIMENTAL

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.

Behavioral: Therapeutic Instrumental Music PerformanceBehavioral: Therapeutic Performance with Sensory-Enhanced Motor Imagery

Therapeutic Performance with Motor Imagery

EXPERIMENTAL

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.

Behavioral: Therapeutic Instrumental Music PerformanceBehavioral: Therapeutic Performance with Motor Imagery

Interventions

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

Therapeutic Instrumental Music PerformanceTherapeutic Performance with Motor ImageryTherapeutic 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 Sensory-Enhanced Motor Imagery

Participants will engage in motor imagery of previously practised movements.

Therapeutic Performance with Motor Imagery

Eligibility Criteria

Age30 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Music, University of Toronto

Toronto, Ontario, M5S2C5, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Michael Thaut, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 11, 2017

Study Start

July 20, 2017

Primary Completion

September 5, 2019

Study Completion

September 5, 2019

Last Updated

September 16, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations