The Effect of Music Listening in Rehabilitation of Subacute Stroke

NCT06469619 | Not Yet Recruiting

• 1 other identifier: R24013
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ischemic Stroke; Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (17)

• Change in lower extremity function

  Functional Ambulation Classification

  At time point 0 and 4-5 weeks later (Before and after intervention)

• Change in lower extremity function

  Berg balance scale

  At time point 0 and 4-5 weeks later (Before and after intervention)

• Change in lower extremity function

  10 m walking test

  At time point 0 and 4-5 weeks later (Before and after intervention)

• Change in lower extremity function

  Timed Up and Go

  At time point 0 and 4-5 weeks later (Before and after intervention)

• Change in upper extremity function

  Box and Block

  At time point 0 and 4-5 weeks later (Before and after intervention)

• Change in upper extremity function

  9-hole Peg Test

  At time point 0 and 4-5 weeks later (Before and after intervention)

• Change in upper extremity function

  Grip strength

  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)

  At time point 0 and 4-5 weeks later (Before and after intervention)

• Change in speech

  Boston Naming Test

  At time point 0 and 4-5 weeks later (Before and after intervention)

• Change in speech

  Western Aphasia Battery

  At time point 0 and 4-5 weeks later (Before and after intervention)

• Change in speech

  Token

  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)

  At time point 0 and 4-5 weeks later (Before and after intervention)

• Mood

  Visual Analogue Mood Scale

  At time point 0 and 4-5 weeks later (Before and after intervention)

• Mood

  Beck Depression Inventory

  At time point 0 and 4-5 weeks later (Before and after intervention)

• Mood

  Generalized Anxiety Disorder-7

  At time point 0 and 4-5 weeks later (Before and after intervention)

• Daily functions

  Rivermead Motor Assessment Gross function

  At time point 0 and 4-5 weeks later (Before and after intervention)

• Daily functions

  Functional Status Questionnaire (FSQfin)

  At time point 0 and 4-5 weeks later (Before and after intervention)

Study Arms (2)

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.

Behavioral: Music listening

Interventions

Music listening BEHAVIORAL

Listening to music of one's choice one hour daily.

Music group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hemispheric stroke (ischemic or intracerebral hemorrhage) during last 4 weeks OR spinal cord injury in last 6 months, causing a need of intensive rehabilitation

You may not qualify if:

• 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

Sponsors & Collaborators

• Maria Sariola: lead

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Johanna Palmio

  The Wellbeing Services County of Pirkanmaa, Tampere University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Sariola

CONTACT

+3583311611; maria.sariola@pirha.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Physiotherapists, occupational therapists and speech therapists who are responsible for rehabilitation and perform the testing
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neurologist

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 21, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share