Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-27 @ 11:48 PM
Study NCT ID:
NCT06763003
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-08
First Post:
2024-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Music Therapy on Cognitive Function in Subacute Stroke Rehabilitation in Malaysia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-12-11', 'size': 380719, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2024-12-31T12:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participant, care provider, investigator and outcome assessor will be evaluated by different disciplines.\n\n1. Participant - ramdomised by principal investigator\n2. care provider - music therapist\n3. Investigator - rehabilitation specialist\n4. outcome assessor - neuropsychologist'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2024-12-22', 'studyFirstSubmitQcDate': '2025-01-07', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'This will be assessed at baseline, after completion of 8 sessions, an average of 2 weeks and also at 1 month after completion.', 'description': 'is noteworthy for being greater sensitivity than the other test and can detect more mild deficits'}, {'measure': 'Trail Making Test (TMT)', 'timeFrame': 'This will be assessed at baseline, after completion of 8 sessions, an average of 2 weeks and also at 1 month after completion.', 'description': 'is easy to understand, and has a short administration which assesses visuoperceptual tracking, processing speed, divided attention, and cognitive flexibility.'}, {'measure': 'Digit Span (Forward and Backward)', 'timeFrame': 'This will be assessed at baseline, after completion of 8 sessions, an average of 2 weeks and also at 1 month after completion.', 'description': 'is easy to implement, requires minimal training needs, and measures selective attention and cognitive interference'}, {'measure': 'Clock Drawing Test (CDT)', 'timeFrame': 'This will be assessed at baseline, after completion of 8 sessions, an average of 2 weeks and also at 1 month after completion.', 'description': 'is a screening test for cognitive dysfunction secondary to dementia, delirium, or a range of neurological and psychiatric illnesses'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Music therapy', 'randomised controlled trial', 'rehabilitation', 'stroke', 'cognition', 'attention'], 'conditions': ['Rehabilitation', 'Cognition', 'Stroke', 'Attention']}, 'referencesModule': {'references': [{'pmid': '28149509', 'type': 'RESULT', 'citation': "Fang R, Ye S, Huangfu J, Calimag DP. Music therapy is a potential intervention for cognition of Alzheimer's Disease: a mini-review. Transl Neurodegener. 2017 Jan 25;6:2. doi: 10.1186/s40035-017-0073-9. eCollection 2017."}, {'pmid': '19607808', 'type': 'RESULT', 'citation': 'Koo SC, Moon BC, Kim JK, Kim CY, Sung SJ, Kim MC, Cho MJ, Cheong YH. OsBWMK1 mediates SA-dependent defense responses by activating the transcription factor OsWRKY33. Biochem Biophys Res Commun. 2009 Sep 18;387(2):365-70. doi: 10.1016/j.bbrc.2009.07.026. Epub 2009 Jul 14.'}, {'pmid': '22116038', 'type': 'RESULT', 'citation': 'Alluri V, Toiviainen P, Jaaskelainen IP, Glerean E, Sams M, Brattico E. Large-scale brain networks emerge from dynamic processing of musical timbre, key and rhythm. Neuroimage. 2012 Feb 15;59(4):3677-89. doi: 10.1016/j.neuroimage.2011.11.019. Epub 2011 Nov 12.'}, {'type': 'RESULT', 'citation': 'Thaut, M. H. (2010). Neurologic Music Therapy in cognitive rehabilitation. Music Perception, 27(4), 281-285.'}, {'pmid': '19673815', 'type': 'RESULT', 'citation': 'Thaut MH, Gardiner JC, Holmberg D, Horwitz J, Kent L, Andrews G, Donelan B, McIntosh GR. Neurologic music therapy improves executive function and emotional adjustment in traumatic brain injury rehabilitation. Ann N Y Acad Sci. 2009 Jul;1169:406-16. doi: 10.1111/j.1749-6632.2009.04585.x.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to explore whether intensive music therapy can help improve cognitive functions like memory, attention, and decision-making skills in stroke patients who are undergoing rehabilitation.\n\nThis is a feasibility study, meaning it's also designed to see how practical it is to include music therapy as part of stroke rehabilitation. The investigators want to learn how well patients can participate in and stick with this type of therapy, and whether it fits well with other treatments that stroke patients usually receive. By understanding this, the investigators can assess the resources, staff training, and planning needed for music therapy to be part of stroke recovery in the future.\n\nThe study will also help the investigators estimate the effects of music therapy, which will be used to design a larger, more detailed study in the future.", 'detailedDescription': "This study will be a feasibility randomised controlled trial (RCT) in one centre, with two parallel groups: an intervention group receiving intensive music therapy in addition to standard neurorehabilitation, and a control group receiving only standard neurorehabilitation. A certified music therapist will conduct the intervention and a trained assessor will evaluate the outcome. The assessor is blinded to the patients' allocation group and will evaluate the cognitive outcomes at baseline, at two weeks (after 8 sessions) and at 1 month post intervention. All patients whoare admitted to the rehabilitation ward for stroke rehabilitation will be screened and approached. Informed consent will be obtained from eligible patients before randomisation. To ensure that there are exactly 15 patients in both the control and intervention groups, block randomization will be used using a random number generator. After randomization, the group assignments will be kept in a password-protected file that only the study coordinator can access. The assessor will not have access to this information because the patients will be labelled with anonymous codes that do not reveal whether they are in the control or intervention group. The assessor will only know the code, not the group assignment, ensuring unbiased evaluation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with ischemic or haemorrhagic stroke confirmed by CT scan\n* Duration of stroke within the first 3 months\n* Aged 18 - 75 years old\n* Ability to provide informed consent\n* Understands Bahasa Melayu or English with basic communication abilities to follow instructions during therapy sessions\n* Mild to moderate cognitive impairments with MoCA score of 10-25.\n\nExclusion Criteria:\n\n* Severe aphasia\n* Significant uncorrected hearing or visual impairments preventing engagement in music therapy.\n* Severe or unstable medical conditions (e.g., uncontrolled hypertension or diabetes).\n* Medications that significantly impair cognition or motor function (e.g., high dose sedatives).\n* History of neurological diseases other than stroke (eg, Parkinson's disease)."}, 'identificationModule': {'nctId': 'NCT06763003', 'briefTitle': 'Intensive Music Therapy on Cognitive Function in Subacute Stroke Rehabilitation in Malaysia', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'Feasibility Randomised Controlled Trial of Intensive Music Therapy on Cognitive Function in Subacute Stroke Rehabilitation in Malaysia', 'orgStudyIdInfo': {'id': 'Intensive MT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care group', 'description': "In the control group, participants will receive the standard neurorehabilitation program prescribed by the rehabilitation team, without the addition of music therapy. This will provide a baseline to compare outcomes with the intervention group and evaluate the feasibility and preliminary effects of the music therapy intervention. The usual cognitive rehabilitation program during the subacute stroke period focuses on restoring cognitive abilities such as attention, memory, executive functions, and communication. The control group's daily rehabilitation sessions will last for 45 minutes, mirroring the music therapy group's session duration, ensuring a fair comparison of outcomes across both groups. This comparison will help assess the unique contributions of music therapy on cognitive functions like attention, memory, and executive functions in stroke patients.", 'interventionNames': ['Other: Standard Care (in control arm)']}, {'type': 'EXPERIMENTAL', 'label': 'Music Therapy Group', 'description': "The music therapy session described follows a structured and engaging approach, aimed at enhancing the patient's cognitive skills during neurorehabilitation. Here's a summary of the session components: Relaxation Phase, Song Selection, Instrument Selection and Familiarization, Rhythmic Training, Progression and Adjustment, Session Frequency and Customization. This individualized approach aims to enhance patient engagement and recovery by integrating music, rhythm, and therapeutic interaction into the neurorehabilitation process.", 'interventionNames': ['Other: Music Therapy']}], 'interventions': [{'name': 'Music Therapy', 'type': 'OTHER', 'description': "The music therapy session described follows a structured and engaging approach, aimed at enhancing the patient's cognitive skills during neurorehabilitation. Here's a summary of the session components: Relaxation Phase, Song Selection, Instrument Selection and Familiarization, Rhythmic Training, Progression and Adjustment, Session Frequency and Customization. This individualized approach aims to enhance patient engagement and recovery by integrating music, rhythm, and therapeutic interaction into the neurorehabilitation process.", 'armGroupLabels': ['Music Therapy Group']}, {'name': 'Standard Care (in control arm)', 'type': 'OTHER', 'description': "In the control group, participants will receive the standard neurorehabilitation program prescribed by the rehabilitation team, without the addition of music therapy. This will provide a baseline to compare outcomes with the intervention group and evaluate the feasibility and preliminary effects of the music therapy intervention. The usual cognitive rehabilitation program during the subacute stroke period focuses on restoring cognitive abilities such as attention, memory, executive functions, and communication. The control group's daily rehabilitation sessions will last for 45 minutes, mirroring the music therapy group's session duration, ensuring a fair comparison of outcomes across both groups. This comparison will help assess the unique contributions of music therapy on cognitive functions like attention, memory, and executive functions in stroke patients.", 'armGroupLabels': ['Standard Care group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'MAZLINA BINTI MAZLAN PROF, MBBS', 'role': 'CONTACT', 'email': 'mazlinamazlan@um.edu.my', 'phone': '+60379675181'}, {'name': 'NIK SHERINA HAIDI BT HANAFI PROF, MBBS', 'role': 'CONTACT', 'email': 'niksherina@um.edu.my', 'phone': '+60379492802'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'For confidentiality purposes.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Dr. Beh Wen Fen', 'investigatorAffiliation': 'University of Malaya'}}}}