Efficacy of Music-Based Telerehabilitation After Stroke

NCT06804304 | Recruiting

• 1 other identifier: HUS/5459/2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

stroke; music; telerehabilitation; attention; executive function; memory; cognition; language; aphasia; motor; hemiparesis; emotion; depression; anxiety; quality of life; magnetic resonance imaging; neuroplasticity

Outcome Measures

Primary Outcomes (4)

• Change in the cognitive functioning summary score from baseline to 3-month stage

  Cognitive functioning summary score is calculated as an average of rescaled scores in following tests: Montreal Cognitive Assessment (MoCA) total score, MoCA Verbal Fluency subtest total score, Sustained Attention to Response Task (SART; correct responses \& reaction times), Flexible Attention Test (FAT) / Reaction Time subtest (reaction times) and Trail Making subtest (correct responses \& reaction times from difference scores between B part and A part), Simon Task (correct responses \& reaction times from difference scores between Incongruence part and Congruence part), and Wechsler Memory Scale III (WMS-III) / Digit Span subtest (total score) and Spatial Span subtest (total score). Raw scores are rescaled to a scale of 0-100 using min-max normalization \[(x-min(x))/(max(x)-min(x))\*100\] across the measurement points. The range of the summary score is 0-100 (higher score indicates better outcome).

  Baseline and 3-month stage

• Change in the speech production summary score from baseline to 3-month stage

  Speech production summary score is calculated as an average of percentage of correct responses (score/maximum value\*100; range 0-100) in the following subtests of the Western Aphasia Battery (WAB): Conversational Question, Picture Description, Repetition, Object Naming, Word Fluency, Sentence Completion, and Responsive Speech. The range of the summary score is 0-100 (higher score indicates better outcome).

  Baseline and 3-month stage

• Change in the upper-extremity motor function summary score from baseline to 3-month stage

  Upper-extremity motor function summary score is calculated as an average of percentage of correct responses (score/maximum value\*100; range 0-100) in following tests: Action Research Arm Test (ARAT; total score), Box and Block Test (BBT; total score), and Purdue Pegboard Test (PPT; total score). The range of the summary score is 0-100 (higher score indicates better outcome).

  Baseline and 3-month stage

• Change in the mood and quality of life summary score from baseline to 3-month stage

  Mood and quality of life summary score is calculated as an average of percentage scores (score/maximum value\*100; range 0-100) in following self-report questionnaires: Patient-Reported Outcomes Measurement Information System (PROMIS) / Depression scale (total score), PROMIS / Anxiety scale (total score), and Stroke Impact Scale (SIS; total score). The scores of the PROMIS are reversed to align with the SIS scores. The range of the summary score is 0-100 (higher score indicates better outcome).

  Baseline and 3-month stage

Secondary Outcomes (109)

• Change in the cognitive functioning summary score from baseline to 6-month stage

  Baseline and 6-month stage

• Change in the speech production summary score from baseline to 6-month stage

  Baseline and 6-month stage

• Change in the upper-extremity motor function summary score from baseline to 6-month stage

  Baseline and 6-month stage

• Change in the mood and quality of life summary score from baseline to 6-month stage

  Baseline and 6-month stage

• Change in the attention summary score from baseline to 3-month and 6-month stages

  Baseline, 3-month stage, and 6-month stage

Other Outcomes (26)

• Change in the MIT phrase repetition score from baseline to 3-month and 6-month stages

  Baseline, 3-month stage, and 6-month stage

• Change in verbal production in a singing task of the music intervention from baseline to 3-month and 6-month stages

  Baseline, 3-month stage, and 6-month stage

• Change in musical production in a singing task of the music intervention from baseline to 3-month and 6-month stages

  Baseline, 3-month stage, and 6-month stage

Study Arms (2)

Music intervention plus standard care

EXPERIMENTAL

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).

Behavioral: Music-based telerehabilitation

Standard care only

NO INTERVENTION

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.

Interventions

Music-based telerehabilitation 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).

Music intervention plus standard care

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Teppo Sarkamo: lead
• HUS Neurocenter: collaborator
• HUS Medical Imaging Centre: collaborator
• University of Jyvaskyla: collaborator
• Finnish Brain Association: collaborator
• Uusimaa Stroke Association: collaborator

Study Sites (1)

University of Helsinki / Faculty of Medicine / Department of Psychology

Helsinki, 00014, Finland

RECRUITING

MeSH Terms

Conditions

Stroke; Language; Aphasia; Paresis; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Communication; Behavior; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Mental Disorders

Study Officials

• Teppo Särkämö, Ph.D.

  University of Helsinki / Faculty of Medicine / Department of Psychology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teppo Särkämö, Ph.D.

CONTACT

+358505399065; teppo.sarkamo@helsinki.fi

Nella Moisseinen, M.A.

CONTACT

+358504070507; nella.moisseinen@helsinki.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 3, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

FI (1)