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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06469619
Other study ID # R24013
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2024
Est. completion date December 2026

Study information

Verified date June 2024
Source Tampere University Hospital
Contact Maria Sariola
Phone +3583311611
Email maria.sariola@pirha.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 130
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - hemispheric stroke (ischemic or intracerebral hemorrhage) during last 4 weeks OR spinal cord injury in last 6 months, causing a need of intensive rehabilitation Exclusion Criteria: - 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

Study Design


Intervention

Behavioral:
Music listening
Listening to music of one's choice one hour daily.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Maria Sariola

Outcome

Type Measure Description Time frame Safety issue
Primary Change in lower extremity function Functional Ambulation Classification At time point 0 and 4-5 weeks later (Before and after intervention)
Primary Change in lower extremity function Berg balance scale At time point 0 and 4-5 weeks later (Before and after intervention)
Primary Change in lower extremity function 10 m walking test At time point 0 and 4-5 weeks later (Before and after intervention)
Primary Change in lower extremity function Timed Up and Go At time point 0 and 4-5 weeks later (Before and after intervention)
Primary Change in upper extremity function Box and Block At time point 0 and 4-5 weeks later (Before and after intervention)
Primary Change in upper extremity function 9-hole Peg Test At time point 0 and 4-5 weeks later (Before and after intervention)
Primary Change in upper extremity function Grip strength At time point 0 and 4-5 weeks later (Before and after intervention)
Primary 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) At time point 0 and 4-5 weeks later (Before and after intervention)
Primary Change in speech Boston Naming Test At time point 0 and 4-5 weeks later (Before and after intervention)
Primary Change in speech Western Aphasia Battery At time point 0 and 4-5 weeks later (Before and after intervention)
Primary Change in speech Token At time point 0 and 4-5 weeks later (Before and after intervention)
Primary Change in speech Story based on a nine-frame cartoon (standardized point scale) At time point 0 and 4-5 weeks later (Before and after intervention)
Primary Mood Visual Analogue Mood Scale At time point 0 and 4-5 weeks later (Before and after intervention)
Primary Mood Beck Depression Inventory At time point 0 and 4-5 weeks later (Before and after intervention)
Primary Mood Generalized Anxiety Disorder-7 At time point 0 and 4-5 weeks later (Before and after intervention)
Primary Daily functions Rivermead Motor Assessment Gross function At time point 0 and 4-5 weeks later (Before and after intervention)
Primary Daily functions Functional Status Questionnaire (FSQfin) At time point 0 and 4-5 weeks later (Before and after intervention)
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