Music Therapy After Stroke (Subacute Phase)

NCT06291480 | Terminated

• 1 other identifier: NL78853.058.22 / STRUM
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this longitudinal, single-subject study is to investigate the role of motivation in music therapy for stroke patients within the subacute phase, who experience upper limb and/or attention deficits. The main questions it aims to answer are:

• Does music therapy increase patient's motivation to rehabilitate?
• Do increases in motivation correlate with functional improvements, in particular upper limb and/or attention skills? Participants will receive up to 9 music therapy sessions within 3-5 weeks, with functional assessments before and after each period. Each participant serves as their own comparison: researchers will compare a period with standard care only (control phase) to a period with music therapy plus standard care (intervention phase), the order of which will be randomized in advance.

Conditions

Stroke (CVA) or TIA; Stroke/Brain Attack

Keywords

Music Therapy; Neurologic Music Therapy; Movement rehabilitation; Cognitive rehabilitation; Motivation

Outcome Measures

Primary Outcomes (1)

• Motivation: Brain Injury Rehabilitation Trust Motivation Questionnaire (BMQ-S) [self-reported]

  The BMQ-S is a 34-item questionnaire, which measures the motivation levels of the stroke survivor, using a 4-point likert scale (always, often, sometimes, never). Items that involve different factors such as anhedonia, perseveration, poor initiation, or distractibility, are summed to create a total score from 34 to 136, with higher scores representing greater difficulties in motivation.

  This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7).

Secondary Outcomes (7)

• Motor Function: Action Research Arm Test (ARAT)

  This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7).

• Motor Function: Barthel Index (BI)

  This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7).

• Cognition: Cancellation Wechsler Adult Intelligence Scale (WAIS-IV)

  This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7).

• Cognition: Color-Word Interference Test, also known as Stroop test

  This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7).

• Cognition: WAIS IV Digit Span Test - Forward and Backward

  This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7).

Other Outcomes (7)

• Motivation to engage in musical activities: Barcelona Music Reward Questionnaire (BMRQ)

  This outcome measure will be administered once, during the baseline Test Point (TP1) (week 1).

• Quality of Life: EuroQol-5 (EQ-5D-5L)

  This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7).

• Mood: Depression Anxiety Stress Scale-21 (DASS-21)

  This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7).

Study Arms (2)

Music Therapy + Care as Usual

EXPERIMENTAL

9 music therapy sessions within 2-5 weeks during stroke rehabilitation, in addition to care as usual.

Behavioral: Neurologic Music Therapy

Care as Usual

NO INTERVENTION

2-5 weeks of care as usual, without music therapy

Interventions

Neurologic Music Therapy BEHAVIORAL

Music therapy focused on cognitive and motor rehabilitation after stroke (subacute phase).

Music Therapy + Care as Usual

Eligibility Criteria

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

You may qualify if:

• Subjects had their first-ever supratentorial stroke between 2 weeks and up to 6 months before enrolment
• Paretic upper limb and/or attention/ concentration problems
• Ability to communicate in Dutch or English

You may not qualify if:

• Severe (global) aphasia
• paralysis of upper limb
• severe cognitive decline (MMSE \<24)

Sponsors & Collaborators

• Universiteit Leiden: lead
• Amstelring: collaborator

Study Sites (1)

Leo Polak Rehabilitation centre

Amsterdam, Nederland, 1069BW, Netherlands

Location

Related Publications (28)

• Altenmuller E, Marco-Pallares J, Munte TF, Schneider S. Neural reorganization underlies improvement in stroke-induced motor dysfunction by music-supported therapy. Ann N Y Acad Sci. 2009 Jul;1169:395-405. doi: 10.1111/j.1749-6632.2009.04580.x.

  PMID: 19673814 BACKGROUND

• Baltazar, M., Västfjäll, D., Asutay, E., Koppel, L., & Saarikallio, S. (2019). Is it me or the music? Stress reduction and the role of regulation strategies and music. Music & Science, 2. https://doi.org/10.1177/2059204319844161

  BACKGROUND

• Barker-Collo SL, Feigin VL, Lawes CM, Parag V, Senior H, Rodgers A. Reducing attention deficits after stroke using attention process training: a randomized controlled trial. Stroke. 2009 Oct;40(10):3293-8. doi: 10.1161/STROKEAHA.109.558239. Epub 2009 Jul 23.

  PMID: 19628801 BACKGROUND

• Burger B, Thompson MR, Luck G, Saarikallio S, Toiviainen P. Influences of rhythm- and timbre-related musical features on characteristics of music-induced movement. Front Psychol. 2013 Apr 12;4:183. doi: 10.3389/fpsyg.2013.00183. eCollection 2013.

  PMID: 23641220 BACKGROUND

• Dimitriadis T, Della Porta D, Perschl J, Evers AWM, Magee WL, Schaefer RS. Motivation and music interventions in adults: A systematic review. Neuropsychol Rehabil. 2024 Jun;34(5):649-678. doi: 10.1080/09602011.2023.2224033. Epub 2023 Jun 21.

  PMID: 37340969 BACKGROUND

• Dwan T, Ownsworth T. The Big Five personality factors and psychological well-being following stroke: a systematic review. Disabil Rehabil. 2019 May;41(10):1119-1130. doi: 10.1080/09638288.2017.1419382. Epub 2017 Dec 22.

  PMID: 29272953 BACKGROUND

• Fine, E. & Delis, D. (2011) Delis-Kaplan Executive Functioning System. In J. S. Kreutzer, J. DeLuca, and B. Caplan (Eds) Encyclopedia of Clinical Neuropsychology,. New York, NY: Springer, pp. 796-801. doi: 10.1007/978-0-387-79948- 3_1539.

  BACKGROUND

• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

• Fujioka T, Dawson DR, Wright R, Honjo K, Chen JL, Chen JJ, Black SE, Stuss DT, Ross B. The effects of music-supported therapy on motor, cognitive, and psychosocial functions in chronic stroke. Ann N Y Acad Sci. 2018 May 24. doi: 10.1111/nyas.13706. Online ahead of print.

  PMID: 29797585 BACKGROUND

• Grau-Sanchez J, Duarte E, Ramos-Escobar N, Sierpowska J, Rueda N, Redon S, Veciana de Las Heras M, Pedro J, Sarkamo T, Rodriguez-Fornells A. Music-supported therapy in the rehabilitation of subacute stroke patients: a randomized controlled trial. Ann N Y Acad Sci. 2018 Apr 1. doi: 10.1111/nyas.13590. Online ahead of print.

  PMID: 29607506 BACKGROUND

• Grau-Sanchez J, Munte TF, Altenmuller E, Duarte E, Rodriguez-Fornells A. Potential benefits of music playing in stroke upper limb motor rehabilitation. Neurosci Biobehav Rev. 2020 May;112:585-599. doi: 10.1016/j.neubiorev.2020.02.027. Epub 2020 Feb 21.

  PMID: 32092314 BACKGROUND

• Kim SY, Kim JM, Stewart R, Kang HJ, Kim SW, Shin IS, Park MS, Cho KH, Yoon JS. Influences of personality traits on quality of life after stroke. Eur Neurol. 2013;69(3):185-92. doi: 10.1159/000345699. Epub 2013 Jan 10.

  PMID: 23306809 BACKGROUND

• Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.

  PMID: 12907818 BACKGROUND

• Mas-Herrero, E., Marco-Pallares, J., Lorenzo-Seva, U., Zatorre, R. J., & Rodriguez-Fornells, A. (2012). Individual differences in music reward experiences. Music Perception: An Interdisciplinary Journal, 31(2), 118-138.

  BACKGROUND

• Oddy M, Cattran C, Wood R. The development of a measure of motivational changes following acquired brain injury. J Clin Exp Neuropsychol. 2008 Jul;30(5):568-75. doi: 10.1080/13803390701555598.

  PMID: 18569252 BACKGROUND

• Olgiati E, Russell C, Soto D, Malhotra P. Motivation and attention following hemispheric stroke. Prog Brain Res. 2016;229:343-366. doi: 10.1016/bs.pbr.2016.06.011. Epub 2016 Sep 16.

  PMID: 27926447 BACKGROUND

• Oyake K, Suzuki M, Otaka Y, Tanaka S. Motivational Strategies for Stroke Rehabilitation: A Descriptive Cross-Sectional Study. Front Neurol. 2020 Jun 10;11:553. doi: 10.3389/fneur.2020.00553. eCollection 2020.

  PMID: 32587572 BACKGROUND

• Raglio A, Zaliani A, Baiardi P, Bossi D, Sguazzin C, Capodaglio E, Imbriani C, Gontero G, Imbriani M. Active music therapy approach for stroke patients in the post-acute rehabilitation. Neurol Sci. 2017 May;38(5):893-897. doi: 10.1007/s10072-017-2827-7. Epub 2017 Jan 30.

  PMID: 28138867 BACKGROUND

• Ripolles P, Rojo N, Grau-Sanchez J, Amengual JL, Camara E, Marco-Pallares J, Juncadella M, Vaquero L, Rubio F, Duarte E, Garrido C, Altenmuller E, Munte TF, Rodriguez-Fornells A. Music supported therapy promotes motor plasticity in individuals with chronic stroke. Brain Imaging Behav. 2016 Dec;10(4):1289-1307. doi: 10.1007/s11682-015-9498-x.

  PMID: 26707190 BACKGROUND

• Schaefer RS. Auditory rhythmic cueing in movement rehabilitation: findings and possible mechanisms. Philos Trans R Soc Lond B Biol Sci. 2014 Dec 19;369(1658):20130402. doi: 10.1098/rstb.2013.0402.

  PMID: 25385780 BACKGROUND

• Schneider S, Schonle PW, Altenmuller E, Munte TF. Using musical instruments to improve motor skill recovery following a stroke. J Neurol. 2007 Oct;254(10):1339-46. doi: 10.1007/s00415-006-0523-2. Epub 2007 Jan 27.

  PMID: 17260171 BACKGROUND

• Stone SP, Ali B, Auberleek I, Thompsell A, Young A. The Barthel index in clinical practice: use on a rehabilitation ward for elderly people. J R Coll Physicians Lond. 1994 Sep-Oct;28(5):419-23.

  PMID: 7807430 BACKGROUND

• Street AJ, Magee WL, Odell-Miller H, Bateman A, Fachner JC. Home-based neurologic music therapy for upper limb rehabilitation with stroke patients at community rehabilitation stage-a feasibility study protocol. Front Hum Neurosci. 2015 Sep 23;9:480. doi: 10.3389/fnhum.2015.00480. eCollection 2015.

  PMID: 26441586 BACKGROUND

• Street, A., Fachner, J. & Magee, W. (2019) Upper limb rehabilitation in chronic stroke using neurologic music therapy: Two contrasting case studies to inform on treatment delivery and patient suitability, Nordic Journal of Music Therapy, 28:5, 382-404, DOI: 10.1080/08098131.2019.1606848

  BACKGROUND

• Thaut, M. H., & Hoemberg, V. (Eds.). (2014). Handbook of neurologic music therapy. Oxford University Press.

  BACKGROUND

• Tong Y, Forreider B, Sun X, Geng X, Zhang W, Du H, Zhang T, Ding Y. Music-supported therapy (MST) in improving post-stroke patients' upper-limb motor function: a randomised controlled pilot study. Neurol Res. 2015 May;37(5):434-40. doi: 10.1179/1743132815Y.0000000034. Epub 2015 Apr 27.

  PMID: 25916420 BACKGROUND

• Verrienti G, Raccagni C, Lombardozzi G, De Bartolo D, Iosa M. Motivation as a Measurable Outcome in Stroke Rehabilitation: A Systematic Review of the Literature. Int J Environ Res Public Health. 2023 Feb 26;20(5):4187. doi: 10.3390/ijerph20054187.

  PMID: 36901206 BACKGROUND

• van Alphen R, Stams GJJM, Hakvoort L. Musical Attention Control Training for Psychotic Psychiatric Patients: An Experimental Pilot Study in a Forensic Psychiatric Hospital. Front Neurosci. 2019 Jun 7;13:570. doi: 10.3389/fnins.2019.00570. eCollection 2019.

  PMID: 31231183 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hanneke Hulst, PhD

  Leiden University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Analyses will be done after blinding to participant id and gender.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Intervention period compared to care as usual in cross-over design.

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: March 4, 2024
• Study Start: January 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: September 15, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Coded data will be published in online scientific archive without a time limit, all participant data, including physical documents will be archived at Faculty of Social and Behavioural Sciences at Leiden university for 10 years.
• Access Criteria: Coded data that cannot be traceable to the participant identifying information will be published in an online repository, the web address of the repository will be included for each publication that results from the study. No restriction to access the publicly available data will be imposed, however, future studies that use the data of the study will be required to make reference to the study AND/OR the repository.

Locations

NL (1)