Efficacy of Music-Based Telerehabilitation After Stroke

NCT ID: NCT06804304

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2028-12-31

Brief Summary

The goal of this clinical trial is to learn if a music-based telerehabilitation intervention implemented at home works to treat different kinds of neurological deficits caused by stroke. The main questions it aims to answer are: 1) Can the music intervention improve recovery of cognitive, verbal, motor, and emotional deficits after stroke, 2) can the music intervention enhance structural and functional recovery of the brain, and (3) how different demographic, musical, and clinical background factors affect the way the music intervention works. Researchers will compare the music intervention to standard (usual) care to see if the music intervention works to treat the deficits caused by stroke. Subjects are stroke patients who will participate either in the music intervention 5 times/week for 10 weeks in addition to standard care or receive standard care only. During the trial, the subjects will undergo neuropsychological testing and magnetic resonance imaging (MRI) three times: at baseline (before the intervention), at 3-month stage (immediately after the intervention), and at 6-month stage (3 months after the intervention).

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Music intervention plus standard care

Participation in a music-based telerehabilitation program (10 weeks, 5 days/week, 60 min/day) in addition to standard care for post-stroke deficits provided in public health care (physical therapy, occupational therapy, speech therapy, and/or neuropsychological rehabilitation).

Group Type: EXPERIMENTAL

Music-based telerehabilitation

Intervention Type: BEHAVIORAL

The music-based telerehabilitation program is a 10-week multicomponent intervention which includes (1) rhythm-based training of motor and cognitive (attention, working memory, executive function) functions, (2) singing-based training of speech production (using singing and melodic intonation therapy training), (3) playing-based training of upper-extremity motor functions (using instrumental training with a xylophone), and (4) music listening for enhancement of mood, attention, and memory. Training is done using a tablet computer and an online platform comprising a collection of short (3-5 min) training videos for each of the 4 training modules, which the patients are instructed to train with at home for 4 days / week (60 min/day). Additionally, the patients participate in a remote (online) music therapy session led by a music therapist for 1 day/week (60 min).

Standard care only

Standard care for post-stroke deficits provided in public health care (physical therapy, occupational therapy, speech therapy, and/or neuropsychological rehabilitation). No additional intervention is provided.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music-based telerehabilitation

The music-based telerehabilitation program is a 10-week multicomponent intervention which includes (1) rhythm-based training of motor and cognitive (attention, working memory, executive function) functions, (2) singing-based training of speech production (using singing and melodic intonation therapy training), (3) playing-based training of upper-extremity motor functions (using instrumental training with a xylophone), and (4) music listening for enhancement of mood, attention, and memory. Training is done using a tablet computer and an online platform comprising a collection of short (3-5 min) training videos for each of the 4 training modules, which the patients are instructed to train with at home for 4 days / week (60 min/day). Additionally, the patients participate in a remote (online) music therapy session led by a music therapist for 1 day/week (60 min).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Left or right hemisphere stroke which has occurred 3-12 months ago
• At least mild cognitive deficit and mild aphasia / upper-extremity hemiparesis caused by the stroke
• Age 30-80 years
• Right-handed
• Finnish-speaking (or bilingual, able to participate in Finnish)
• Understands the purpose of the study and is able to give informed consent

Exclusion Criteria

• Prior significant hearing or visual impairment
• Prior severe psychiatric illness (e.g., schizopheria, bipolar disorder, severe unipolar depression)
• Prior severe neurological illness (e.g., brain injury, dementia; can have prior TIA or mild stroke)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HUS Neurocenter

UNKNOWN

Sponsor Role: collaborator

HUS Medical Imaging Centre

UNKNOWN

Sponsor Role: collaborator

University of Jyvaskyla

OTHER

Sponsor Role: collaborator

Finnish Brain Association

UNKNOWN

Sponsor Role: collaborator

Uusimaa Stroke Association

UNKNOWN

Sponsor Role: collaborator

Teppo Sarkamo

OTHER

Sponsor Role: lead

Responsible Party

Teppo Sarkamo

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Teppo Särkämö, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Helsinki / Faculty of Medicine / Department of Psychology

Locations

University of Helsinki / Faculty of Medicine / Department of Psychology

Helsinki, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Teppo Särkämö, Ph.D.

Role: CONTACT

teppo.sarkamo@helsinki.fi

+358505399065

Nella Moisseinen, M.A.

Role: CONTACT

nella.moisseinen@helsinki.fi

+358504070507

Facility Contacts

Nella Moisseinen, M.A.

Role: primary

nella.moisseinen@helsinki.fi

+358504070507

Teppo Särkämö, Ph.D.

Role: backup

teppo.sarkamo@helsinki.fi

+358505399065

Other Identifiers

HUS/5459/2024

Identifier Type: -

Identifier Source: org_study_id