StrokeNCT03246217
Therapeutic Instrumental Music Performance With Sensory-Enhanced Motor Imagery in Chronic Post-Stroke Rehabilitation
A study testing Therapeutic Instrumental Music Performance, Therapeutic Performance with Sensory-Enhanced Motor Imagery and Therapeutic Performance with Motor Imagery in people with Stroke, run by University of Toronto at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Stroke
- What is being tested?
- Therapeutic Instrumental Music Performance, Therapeutic Performance with Sensory-Enhanced Motor Imagery and Therapeutic Performance with Motor Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jul 2017to 5 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Therapeutic Instrumental Music Performance With Sensory-Enhanced Motor Imagery in Improving Therapeutic Outcomes for Individuals With Chronic Post-Stroke Hemiparesis
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Therapeutic Instrumental Music Performance, Therapeutic Performance with Sensory-Enhanced Motor Imagery, Therapeutic Performance with Motor Imagery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Instrumental Music PerformanceBehavioural
Participants will play a variety of instruments (acoustic and electronic) to facilitate retraining of everyday functional movements.
Therapeutic Performance with Sensory-Enhanced Motor ImageryBehavioural
Participants will listen to a metronome set to their preferred pace for previously practised movements while engaging in motor imagery.
Therapeutic Performance with Motor ImageryBehavioural
Participants will engage in motor imagery of previously practised movements.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Therapeutic Instrumental Music Performance; Behavioral: 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. Receives: Behavioral: Therapeutic Instrumental Music Performance; Behavioral: Therapeutic Performance with Motor Imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in Wolf Motor Function Test
Measures upper extremity motor ability through timed and functional tasks.
Measured: 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.
Measured: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Secondary outcomes (6)
Motor Activity Log
Individuals rate quality and amount of movement during daily functional tasks.
Measured: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Trunk Impairment Scale
Assessment of upper trunk impairment using the upper trunk items of the Trunk Impairment Scale
Measured: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Multiple Affect Adjective Check List-Revised
Measure of affective state
Measured: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
General Self-Efficacy Scale
Assessment of perceived self-efficacy
Measured: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Digit Span
Assesses working memory and attention
Measured: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Trail Making Test Part B
Assesses mental flexibility and processing speed
Measured: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start20 Jul 2017
- Primary completion5 Sep 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Haire, University of Toronto
- Investigators
- Michael Thaut, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246217
- Sponsor's protocol ID
- #34521
- Status last verified
- Sep 2019
- First submitted
- 7 Aug 2017
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36262914
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Therapeutic Instrumental Music Performance With Sensory-Enhanced Motor Imagery in Improving Therapeutic Outcomes for Individuals With Chronic Post-Stroke Hemiparesis
- ClinicalTrials.gov ID
- NCT03246217
- Acronym / sponsor ID
- #34521
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Instrumental Music Performance | Experimental | Behavioral: Therapeutic Instrumental Music PerformanceTherapeutic 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. |
| Therapeutic Performance with Sensory-Enhanced Motor Imagery | Experimental | Behavioral: Therapeutic Instrumental Music Performance, Behavioral: Therapeutic Performance with Sensory-Enhanced Motor ImageryParticipants 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. |
| Therapeutic Performance with Motor Imagery | Experimental | Behavioral: Therapeutic Instrumental Music Performance, Behavioral: Therapeutic Performance with Motor ImageryParticipants 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. |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Instrumental Music PerformanceParticipants will play a variety of instruments (acoustic and electronic) to facilitate retraining of everyday functional movements. | Behavioural | Therapeutic Instrumental Music Performance, Therapeutic Performance with Motor Imagery, Therapeutic Performance with Sensory-Enhanced Motor Imagery |
| Therapeutic Performance with Sensory-Enhanced Motor ImageryParticipants will listen to a metronome set to their preferred pace for previously practised movements while engaging in motor imagery. | Behavioural | Therapeutic Performance with Sensory-Enhanced Motor Imagery |
| Therapeutic Performance with Motor ImageryParticipants will engage in motor imagery of previously practised movements. | Behavioural | Therapeutic Performance with Motor Imagery |
Primary outcome
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.
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.
6 secondary outcomes
Motor Activity Log
Time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Trunk Impairment Scale
Time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Multiple Affect Adjective Check List-Revised
Time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
General Self-Efficacy Scale
Time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Digit Span
Time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Trail Making Test Part B
Time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Derived from this study: PubMed 36262914Loria 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.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Thaut, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Instrumental Music Performance, Therapeutic Performance with Sensory-Enhanced Motor Imagery and Therapeutic Performance with Motor Imagery in people with Stroke, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in Wolf Motor Function Test (time frame: Baseline 1, Baseline 2 (1 week later), Post intervention of 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03246217, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.