Ischemic StrokeNCT06469619
The Effect of Music Listening in Rehabilitation of Subacute Stroke
A study testing Music listening in people with Ischemic Stroke and Intracerebral Hemorrhage, run by Maria Sariola.
Trial summary
Music listening has many positive effects on the brain. This study aims to find out if people with stroke get better results with their rehabilitation if they listen to music during their passive hours. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke, Intracerebral Hemorrhage
- What is being tested?
- Music listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hemispheric stroke (ischemic or intracerebral hemorrhage) during last 4 weeks OR spinal cord injury in last 6 months, causing a need of intensive rehabilitation
Who cannot join
- severe hearing loss preventing music listening
- previous condition of neurological disease of dementia that significantly affects daily functions
- active drug use or acute psychiatric condition
- unable to understand given information and give consent to participate
- for spinal cord injury patients: acute traumatic brain injury or stroke
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Music listening has many positive effects on the brain. This study aims to find out if people with stroke get better results with their rehabilitation if they listen to music during their passive hours. The study is a randomized controlled trial with people who are at a rehabilitation center care after stroke at Tampere University Hospital. The control group gets standard rehabilitation. Music group gets standard rehabilitation and in addition they listen to music one hour a day during four weeks. Physiotherapists, occupational therapists and speech therapists test how well the participant's walking, use of hand and speech improve. The main goal is to find out if the improvement is better with music listening. The study also monitors effects of music listening on mood in rehabilitation.
- Conditions
- Ischemic Stroke, Intracerebral Hemorrhage
- Being tested
- Music listening
- Medical subject headings
- Ischemic Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music listeningBehavioural
Listening to music of one's choice one hour daily.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Standard care and rehabilitation. |
| Music group | Experimental | Standard care and rehabilitation and music listening one hour a day during 4 weeks. Receives: Behavioral: Music listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lower extremity function
Functional Ambulation Classification
Measured: At time point 0 and 4-5 weeks later (Before and after intervention)
Change in lower extremity function
Berg balance scale
Measured: At time point 0 and 4-5 weeks later (Before and after intervention)
Change in lower extremity function
10 m walking test
Measured: At time point 0 and 4-5 weeks later (Before and after intervention)
Change in lower extremity function
Timed Up and Go
Measured: At time point 0 and 4-5 weeks later (Before and after intervention)
Change in upper extremity function
Box and Block
Measured: At time point 0 and 4-5 weeks later (Before and after intervention)
Change in upper extremity function
9-hole Peg Test
Measured: At time point 0 and 4-5 weeks later (Before and after intervention)
Change in upper extremity function
Grip strength
Measured: At time point 0 and 4-5 weeks later (Before and after intervention)
Change in upper extremity function
Arm abduction (scale 1-3, 1 = normal, 2 = able to lift between horizontal plane but with at least 30 degrees deficiency, 3 = unable to lift above horizontal plane)
Measured: At time point 0 and 4-5 weeks later (Before and after intervention)
Change in speech
Boston Naming Test
Measured: At time point 0 and 4-5 weeks later (Before and after intervention)
Change in speech
Western Aphasia Battery
Measured: At time point 0 and 4-5 weeks later (Before and after intervention)
Change in speech
Token
Measured: At time point 0 and 4-5 weeks later (Before and after intervention)
Change in speech
Story based on a nine-frame cartoon (standardized point scale)
Measured: At time point 0 and 4-5 weeks later (Before and after intervention)
Mood
Visual Analogue Mood Scale
Measured: At time point 0 and 4-5 weeks later (Before and after intervention)
Mood
Beck Depression Inventory
Measured: At time point 0 and 4-5 weeks later (Before and after intervention)
Mood
Generalized Anxiety Disorder-7
Measured: At time point 0 and 4-5 weeks later (Before and after intervention)
Daily functions
Rivermead Motor Assessment Gross function
Measured: At time point 0 and 4-5 weeks later (Before and after intervention)
Daily functions
Functional Status Questionnaire (FSQfin)
Measured: At time point 0 and 4-5 weeks later (Before and after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study startAug 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sariola
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maria Sariola, Tampere University Hospital
- Investigators
- Johanna Palmio, Principal investigator, The Wellbeing Services County of Pirkanmaa, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469619
- Sponsor's protocol ID
- R24013
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Listening in Rehabilitation of Subacute Stroke
- ClinicalTrials.gov ID
- NCT06469619
- Acronym / sponsor ID
- R24013
- Conditions
- Ischemic Stroke, Intracerebral Hemorrhage
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Maria SariolaUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Jun 2024 (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.
Music listening has many positive effects on the brain. This study aims to find out if people with stroke get better results with their rehabilitation if they listen to music during their passive hours. The study is a randomized controlled trial with people who are at a rehabilitation center care after stroke at Tampere University Hospital. The control group gets standard rehabilitation. Music group gets standard rehabilitation and in addition they listen to music one hour a day during four weeks. Physiotherapists, occupational therapists and speech therapists test how well the participant's walking, use of hand and speech improve. The main goal is to find out if the improvement is better with music listening. The study also monitors effects of music listening on mood in rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Standard care and rehabilitation. |
| Music group | Experimental | Behavioral: Music listeningStandard care and rehabilitation and music listening one hour a day during 4 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hemispheric stroke (ischemic or intracerebral hemorrhage) during last 4 weeks OR spinal cord injury in last 6 months, causing a need of intensive rehabilitation
Key exclusion criteria (5 listed)
- severe hearing loss preventing music listening
- previous condition of neurological disease of dementia that significantly affects daily functions
- active drug use or acute psychiatric condition
- unable to understand given information and give consent to participate
- for spinal cord injury patients: acute traumatic brain injury or stroke
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 |
|---|---|---|
| Music listeningListening to music of one's choice one hour daily. | Behavioural | Music group |
Primary outcome
Change in lower extremity function
Time frame: At time point 0 and 4-5 weeks later (Before and after intervention)
Functional Ambulation Classification
Change in lower extremity function
Time frame: At time point 0 and 4-5 weeks later (Before and after intervention)
Berg balance scale
Change in lower extremity function
Time frame: At time point 0 and 4-5 weeks later (Before and after intervention)
10 m walking test
Change in lower extremity function
Time frame: At time point 0 and 4-5 weeks later (Before and after intervention)
Timed Up and Go
Change in upper extremity function
Time frame: At time point 0 and 4-5 weeks later (Before and after intervention)
Box and Block
Change in upper extremity function
Time frame: At time point 0 and 4-5 weeks later (Before and after intervention)
9-hole Peg Test
Change in upper extremity function
Time frame: At time point 0 and 4-5 weeks later (Before and after intervention)
Grip strength
Change in upper extremity function
Time frame: At time point 0 and 4-5 weeks later (Before and after intervention)
Arm abduction (scale 1-3, 1 = normal, 2 = able to lift between horizontal plane but with at least 30 degrees deficiency, 3 = unable to lift above horizontal plane)
Change in speech
Time frame: At time point 0 and 4-5 weeks later (Before and after intervention)
Boston Naming Test
Change in speech
Time frame: At time point 0 and 4-5 weeks later (Before and after intervention)
Western Aphasia Battery
Change in speech
Time frame: At time point 0 and 4-5 weeks later (Before and after intervention)
Token
Change in speech
Time frame: At time point 0 and 4-5 weeks later (Before and after intervention)
Story based on a nine-frame cartoon (standardized point scale)
Mood
Time frame: At time point 0 and 4-5 weeks later (Before and after intervention)
Visual Analogue Mood Scale
Mood
Time frame: At time point 0 and 4-5 weeks later (Before and after intervention)
Beck Depression Inventory
Mood
Time frame: At time point 0 and 4-5 weeks later (Before and after intervention)
Generalized Anxiety Disorder-7
Daily functions
Time frame: At time point 0 and 4-5 weeks later (Before and after intervention)
Rivermead Motor Assessment Gross function
Daily functions
Time frame: At time point 0 and 4-5 weeks later (Before and after intervention)
Functional Status Questionnaire (FSQfin)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Ischemic Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Johanna Palmio principal investigator
The Wellbeing Services County of Pirkanmaa, Tampere University
Questions about this trial
What is this clinical trial studying?
A study testing Music listening in people with Ischemic Stroke and Intracerebral Hemorrhage, run by Maria Sariola.
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 1 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: opening soon, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Sariola (+3583311611, maria.sariola@pirha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lower extremity function (time frame: At time point 0 and 4-5 weeks later (Before and after intervention)). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2024.