Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT05637593
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-10
First Post:
2022-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rhythmic Auditory Stimulation on Upper-limb Movements in PD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D018476', 'term': 'Hypokinesia'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 138}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2022-11-24', 'studyFirstSubmitQcDate': '2022-11-24', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The box and block test (BBT)', 'timeFrame': 'Baseline (T1). Before the training. BBT requires 8-10 minutes to administer.', 'description': 'BBT is used to measure manual dexterity as well as upper-limb movement speed. It is a 53.7\\* 25.4 cm box separated into two compartments by a 15.2 cm high erected partition, with 150 blocks in each compartment. Starting from the dominant hand, patients will be asked to move the blocks one by one from the compartment on the hand side to the opposite side (e.g., move the blocks from the right compartment to the left compartment for the right hand test). Patients should move the blocks with their arms raised and crossed over the partition. They have one minute to move the blocks as fast as possible. The score of BBT for each hand is the quantity of blocks transferred between compartments in one minute. A higher score indicates faster upper-limb movements and better dexterity. For the elderly, the BBT has high test-retest reliability (intraclass correlation coefficient of 0.89 to 0.97) and construct validity.'}, {'measure': 'The box and block test (BBT)', 'timeFrame': 'Day 8 (T2). During the training. BBT requires 8-10 minutes to administer.', 'description': 'BBT is used to measure manual dexterity as well as upper-limb movement speed. It is a 53.7\\* 25.4 cm box separated into two compartments by a 15.2 cm high erected partition, with 150 blocks in each compartment. Starting from the dominant hand, patients will be asked to move the blocks one by one from the compartment on the hand side to the opposite side (e.g., move the blocks from the right compartment to the left compartment for the right hand test). Patients should move the blocks with their arms raised and crossed over the partition. They have one minute to move the blocks as fast as possible. The score of BBT for each hand is the quantity of blocks transferred between compartments in one minute. A higher score indicates faster upper-limb movements and better dexterity. For the elderly, the BBT has high test-retest reliability (intraclass correlation coefficient of 0.89 to 0.97) and construct validity.'}, {'measure': 'The box and block test (BBT)', 'timeFrame': 'Day 15 (T3). During the training. BBT requires 8-10 minutes to administer.', 'description': 'BBT is used to measure manual dexterity as well as upper-limb movement speed. It is a 53.7\\* 25.4 cm box separated into two compartments by a 15.2 cm high erected partition, with 150 blocks in each compartment. Starting from the dominant hand, patients will be asked to move the blocks one by one from the compartment on the hand side to the opposite side (e.g., move the blocks from the right compartment to the left compartment for the right hand test). Patients should move the blocks with their arms raised and crossed over the partition. They have one minute to move the blocks as fast as possible. The score of BBT for each hand is the quantity of blocks transferred between compartments in one minute. A higher score indicates faster upper-limb movements and better dexterity. For the elderly, the BBT has high test-retest reliability (intraclass correlation coefficient of 0.89 to 0.97) and construct validity.'}, {'measure': 'The box and block test (BBT)', 'timeFrame': 'Post-intervention (T4). BBT requires 8-10 minutes to administer.', 'description': 'BBT is used to measure manual dexterity as well as upper-limb movement speed. It is a 53.7\\* 25.4 cm box separated into two compartments by a 15.2 cm high erected partition, with 150 blocks in each compartment. Starting from the dominant hand, patients will be asked to move the blocks one by one from the compartment on the hand side to the opposite side (e.g., move the blocks from the right compartment to the left compartment for the right hand test). Patients should move the blocks with their arms raised and crossed over the partition. They have one minute to move the blocks as fast as possible. The score of BBT for each hand is the quantity of blocks transferred between compartments in one minute. A higher score indicates faster upper-limb movements and better dexterity. For the elderly, the BBT has high test-retest reliability (intraclass correlation coefficient of 0.89 to 0.97) and construct validity.'}, {'measure': 'The box and block test (BBT)', 'timeFrame': 'One-month follow-up (T5). BBT requires 8-10 minutes to administer.', 'description': 'BBT is used to measure manual dexterity as well as upper-limb movement speed. It is a 53.7\\* 25.4 cm box separated into two compartments by a 15.2 cm high erected partition, with 150 blocks in each compartment. Starting from the dominant hand, patients will be asked to move the blocks one by one from the compartment on the hand side to the opposite side (e.g., move the blocks from the right compartment to the left compartment for the right hand test). Patients should move the blocks with their arms raised and crossed over the partition. They have one minute to move the blocks as fast as possible. The score of BBT for each hand is the quantity of blocks transferred between compartments in one minute. A higher score indicates faster upper-limb movements and better dexterity. For the elderly, the BBT has high test-retest reliability (intraclass correlation coefficient of 0.89 to 0.97) and construct validity.'}, {'measure': 'The Jebsen hand function test (JHFT)', 'timeFrame': 'Baseline (T1). Before the training. JHFT takes approximately 15 minutes to administer.', 'description': 'JHFT is used to assess unimanual hand function when examinees perform daily activities. Seven items are included in JHFT: writing, turning cards, picking up small objects, simulated feeding, stacking checkers, moving large light objects, and moving large heavy objects. Considering that the patients are Chinese speakers, it is not appropriate to do English writing. According to a previous study conducted in Chinese cultures, the JHFT could be modified through excluding the writing item to avoid cultural influences on scores. The score for each item is the completion time. The less time a patient takes, the better hand function s/he has. The JHFT has excellent test-retest reliability (intraclass correlation coefficients of 0.89 to 0.97) for PD patients.'}, {'measure': 'The Jebsen hand function test (JHFT)', 'timeFrame': 'Day 8 (T2). During the training. JHFT takes approximately 15 minutes to administer.', 'description': 'JHFT is used to assess unimanual hand function when examinees perform daily activities. Seven items are included in JHFT: writing, turning cards, picking up small objects, simulated feeding, stacking checkers, moving large light objects, and moving large heavy objects. Considering that the patients are Chinese speakers, it is not appropriate to do English writing. According to a previous study conducted in Chinese cultures, the JHFT could be modified through excluding the writing item to avoid cultural influences on scores. The score for each item is the completion time. The less time a patient takes, the better hand function s/he has. The JHFT has excellent test-retest reliability (intraclass correlation coefficients of 0.89 to 0.97) for PD patients.'}, {'measure': 'The Jebsen hand function test (JHFT)', 'timeFrame': 'Day 15 (T3). During the training. JHFT takes approximately 15 minutes to administer.', 'description': 'JHFT is used to assess unimanual hand function when examinees perform daily activities. Seven items are included in JHFT: writing, turning cards, picking up small objects, simulated feeding, stacking checkers, moving large light objects, and moving large heavy objects. Considering that the patients are Chinese speakers, it is not appropriate to do English writing. According to a previous study conducted in Chinese cultures, the JHFT could be modified through excluding the writing item to avoid cultural influences on scores. The score for each item is the completion time. The less time a patient takes, the better hand function s/he has. The JHFT has excellent test-retest reliability (intraclass correlation coefficients of 0.89 to 0.97) for PD patients.'}, {'measure': 'The Jebsen hand function test (JHFT)', 'timeFrame': 'Post-intervention (T4). JHFT takes approximately 15 minutes to administer.', 'description': 'JHFT is used to assess unimanual hand function when examinees perform daily activities. Seven items are included in JHFT: writing, turning cards, picking up small objects, simulated feeding, stacking checkers, moving large light objects, and moving large heavy objects. Considering that the patients are Chinese speakers, it is not appropriate to do English writing. According to a previous study conducted in Chinese cultures, the JHFT could be modified through excluding the writing item to avoid cultural influences on scores. The score for each item is the completion time. The less time a patient takes, the better hand function s/he has. The JHFT has excellent test-retest reliability (intraclass correlation coefficients of 0.89 to 0.97) for PD patients.'}, {'measure': 'The Jebsen hand function test (JHFT)', 'timeFrame': 'One-month follow-up (T5). JHFT takes approximately 15 minutes to administer.', 'description': 'JHFT is used to assess unimanual hand function when examinees perform daily activities. Seven items are included in JHFT: writing, turning cards, picking up small objects, simulated feeding, stacking checkers, moving large light objects, and moving large heavy objects. Considering that the patients are Chinese speakers, it is not appropriate to do English writing. According to a previous study conducted in Chinese cultures, the JHFT could be modified through excluding the writing item to avoid cultural influences on scores. The score for each item is the completion time. The less time a patient takes, the better hand function s/he has. The JHFT has excellent test-retest reliability (intraclass correlation coefficients of 0.89 to 0.97) for PD patients.'}, {'measure': "Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale motor section (MDS-UPDRS III)", 'timeFrame': 'Baseline (T1). Before the training. MDS-UPDRS III takes approximately 15 minutes to administer.', 'description': 'The MDS-UPDRS evaluates various aspects of PD, including four parts: subjective non-motor experiences of daily living, subjective motor experiences of daily living, motor examination of the motor signs of PD, and motor complications based on historical and objective information. The scale is widely used in clinical settings as well as in research. We calculated the score of MDS-UPDRS Ⅲ, which is the motor examination of the motor signs, to assess the severity of bradykinesia.'}, {'measure': "Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale motor section (MDS-UPDRS III)", 'timeFrame': 'Post-intervention (T4). MDS-UPDRS III takes approximately 15 minutes to administer.', 'description': 'The MDS-UPDRS evaluates various aspects of PD, including four parts: subjective non-motor experiences of daily living, subjective motor experiences of daily living, motor examination of the motor signs of PD, and motor complications based on historical and objective information. The scale is widely used in clinical settings as well as in research. We calculated the score of MDS-UPDRS Ⅲ, which is the motor examination of the motor signs, to assess the severity of bradykinesia.'}, {'measure': "Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale motor section (MDS-UPDRS III)", 'timeFrame': 'One-month follow-up (T5). MDS-UPDRS III takes approximately 15 minutes to administer.', 'description': 'The MDS-UPDRS evaluates various aspects of PD, including four parts: subjective non-motor experiences of daily living, subjective motor experiences of daily living, motor examination of the motor signs of PD, and motor complications based on historical and objective information. The scale is widely used in clinical settings as well as in research. We calculated the score of MDS-UPDRS Ⅲ, which is the motor examination of the motor signs, to assess the severity of bradykinesia.'}, {'measure': 'The Nine-Hole Peg Test (NHPT)', 'timeFrame': 'Baseline (T1). Before the training. Before the training. NHPT takes approximately 5 minutes to administer.', 'description': 'The NHPT is widely used measure of hand dexterity in a broad range of ages and population. The NHPT requires participants to quickly pick up nine small pegs from a concave receptacle, place them into holes on a board as fast as possible, and then move them back to the receptacle. The total time has been recorded as the result of NHPT, the less time taken indicate better hand dexterity. It has a high test-retest reliability for both hand (intraclass correlation coefficients of 0.88 to 0.91) and construct validity in PD population.'}, {'measure': 'The Nine-Hole Peg Test (NHPT)', 'timeFrame': 'Day 8 (T2). During the training. NHPT takes approximately 5 minutes to administer.', 'description': 'The NHPT is widely used measure of hand dexterity in a broad range of ages and population. The NHPT requires participants to quickly pick up nine small pegs from a concave receptacle, place them into holes on a board as fast as possible, and then move them back to the receptacle. The total time has been recorded as the result of NHPT, the less time taken indicate better hand dexterity. It has a high test-retest reliability for both hand (intraclass correlation coefficients of 0.88 to 0.91) and construct validity in PD population.'}, {'measure': 'The Nine-Hole Peg Test (NHPT)', 'timeFrame': 'Day 15 (T3). During the training. NHPT takes approximately 5 minutes to administer.', 'description': 'The NHPT is widely used measure of hand dexterity in a broad range of ages and population. The NHPT requires participants to quickly pick up nine small pegs from a concave receptacle, place them into holes on a board as fast as possible, and then move them back to the receptacle. The total time has been recorded as the result of NHPT, the less time taken indicate better hand dexterity. It has a high test-retest reliability for both hand (intraclass correlation coefficients of 0.88 to 0.91) and construct validity in PD population.'}, {'measure': 'The Nine-Hole Peg Test (NHPT)', 'timeFrame': 'Post-intervention (T4). NHPT takes approximately 5 minutes to administer.', 'description': 'The NHPT is widely used measure of hand dexterity in a broad range of ages and population. The NHPT requires participants to quickly pick up nine small pegs from a concave receptacle, place them into holes on a board as fast as possible, and then move them back to the receptacle. The total time has been recorded as the result of NHPT, the less time taken indicate better hand dexterity. It has a high test-retest reliability for both hand (intraclass correlation coefficients of 0.88 to 0.91) and construct validity in PD population.'}, {'measure': 'The Nine-Hole Peg Test (NHPT)', 'timeFrame': 'One-month follow-up (T5). NHPT takes approximately 5 minutes to administer.', 'description': 'The NHPT is widely used measure of hand dexterity in a broad range of ages and population. The NHPT requires participants to quickly pick up nine small pegs from a concave receptacle, place them into holes on a board as fast as possible, and then move them back to the receptacle. The total time has been recorded as the result of NHPT, the less time taken indicate better hand dexterity. It has a high test-retest reliability for both hand (intraclass correlation coefficients of 0.88 to 0.91) and construct validity in PD population.'}], 'secondaryOutcomes': [{'measure': 'Electroencephalography (EEG)', 'timeFrame': 'Baseline (T1). Before the training. It takes about 20 minutes to complete all the EEG recording procedures, including setup and removal.', 'description': 'EEG recordings were conducted using a clinical-grade Nicolet Monitor system (Natus Medical Incorporated, USA). The system features comprehensive neurophysiological monitoring capabilities with high signal-to-noise ratio and stable recording characteristics. We employed a standard 19-electrode montage following the international 10-20 system, ensuring precise and reproducible electrode positioning based on anatomical landmarks.'}, {'measure': 'Electroencephalography (EEG)', 'timeFrame': 'Post-intervention (T4). It takes about 20 minutes to complete all the EEG recording procedures, including setup and removal.', 'description': 'EEG recordings were conducted using a clinical-grade Nicolet Monitor system (Natus Medical Incorporated, USA). The system features comprehensive neurophysiological monitoring capabilities with high signal-to-noise ratio and stable recording characteristics. We employed a standard 19-electrode montage following the international 10-20 system, ensuring precise and reproducible electrode positioning based on anatomical landmarks.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acoustic Stimulation', 'Parkinson Disease', 'Movement, Abnormal', 'Bradykinesia', 'Arm']}, 'referencesModule': {'references': [{'pmid': '19041965', 'type': 'BACKGROUND', 'citation': 'Bengtsson SL, Ullen F, Ehrsson HH, Hashimoto T, Kito T, Naito E, Forssberg H, Sadato N. Listening to rhythms activates motor and premotor cortices. Cortex. 2009 Jan;45(1):62-71. doi: 10.1016/j.cortex.2008.07.002. Epub 2008 Oct 30.'}, {'pmid': '30375083', 'type': 'BACKGROUND', 'citation': "Braunlich K, Seger CA, Jentink KG, Buard I, Kluger BM, Thaut MH. Rhythmic auditory cues shape neural network recruitment in Parkinson's disease during repetitive motor behavior. Eur J Neurosci. 2019 Mar;49(6):849-858. doi: 10.1111/ejn.14227. Epub 2018 Dec 3."}, {'pmid': '30837830', 'type': 'BACKGROUND', 'citation': "Buard I, Dewispelaere WB, Thaut M, Kluger BM. Preliminary Neurophysiological Evidence of Altered Cortical Activity and Connectivity With Neurologic Music Therapy in Parkinson's Disease. Front Neurosci. 2019 Feb 19;13:105. doi: 10.3389/fnins.2019.00105. eCollection 2019."}, {'pmid': '14590618', 'type': 'BACKGROUND', 'citation': "Cahn DA, Sullivan EV, Shear PK, Pfefferbaum A, Heit G, Silverberg G. Differential contributions of cognitive and motor component processes to physical and instrumental activities of daily living in Parkinson's disease. Arch Clin Neuropsychol. 1998 Oct;13(7):575-83."}, {'pmid': '18388350', 'type': 'BACKGROUND', 'citation': 'Chen JL, Penhune VB, Zatorre RJ. Listening to musical rhythms recruits motor regions of the brain. Cereb Cortex. 2008 Dec;18(12):2844-54. doi: 10.1093/cercor/bhn042. 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Into the groove: can rhythm influence Parkinson's disease? Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 2):2564-70. doi: 10.1016/j.neubiorev.2013.08.003. Epub 2013 Sep 3."}, {'pmid': '27430479', 'type': 'BACKGROUND', 'citation': "Nonnekes J, Timmer MH, de Vries NM, Rascol O, Helmich RC, Bloem BR. Unmasking levodopa resistance in Parkinson's disease. Mov Disord. 2016 Nov;31(11):1602-1609. doi: 10.1002/mds.26712. Epub 2016 Jul 19."}, {'pmid': '29503325', 'type': 'BACKGROUND', 'citation': "Radhakrishnan DM, Goyal V. Parkinson's disease: A review. Neurol India. 2018 Mar-Apr;66(Supplement):S26-S35. doi: 10.4103/0028-3886.226451."}, {'pmid': '28728161', 'type': 'BACKGROUND', 'citation': "Rajiah K, Maharajan MK, Yeen SJ, Lew S. Quality of Life and Caregivers' Burden of Parkinson's Disease. Neuroepidemiology. 2017;48(3-4):131-137. doi: 10.1159/000479031. Epub 2017 Jul 21."}, {'pmid': '20944662', 'type': 'BACKGROUND', 'citation': "Redgrave P, Rodriguez M, Smith Y, Rodriguez-Oroz MC, Lehericy S, Bergman H, Agid Y, DeLong MR, Obeso JA. Goal-directed and habitual control in the basal ganglia: implications for Parkinson's disease. Nat Rev Neurosci. 2010 Nov;11(11):760-72. doi: 10.1038/nrn2915. Epub 2010 Oct 14."}, {'pmid': '30809175', 'type': 'BACKGROUND', 'citation': 'Schaffert N, Janzen TB, Mattes K, Thaut MH. A Review on the Relationship Between Sound and Movement in Sports and Rehabilitation. Front Psychol. 2019 Feb 12;10:244. doi: 10.3389/fpsyg.2019.00244. eCollection 2019.'}, {'pmid': '10443550', 'type': 'BACKGROUND', 'citation': "Sian J, Gerlach M, Youdim MB, Riederer P. Parkinson's disease: a major hypokinetic basal ganglia disorder. J Neural Transm (Vienna). 1999;106(5-6):443-76. doi: 10.1007/s007020050171."}, {'pmid': '8684391', 'type': 'BACKGROUND', 'citation': "Thaut MH, McIntosh GC, Rice RR, Miller RA, Rathbun J, Brault JM. Rhythmic auditory stimulation in gait training for Parkinson's disease patients. Mov Disord. 1996 Mar;11(2):193-200. doi: 10.1002/mds.870110213."}, {'pmid': '25774137', 'type': 'BACKGROUND', 'citation': 'Thaut MH, McIntosh GC, Hoemberg V. Neurobiological foundations of neurologic music therapy: rhythmic entrainment and the motor system. Front Psychol. 2015 Feb 18;5:1185. doi: 10.3389/fpsyg.2014.01185. eCollection 2014.'}, {'pmid': '30411674', 'type': 'BACKGROUND', 'citation': 'Vitorio R, Stuart S, Gobbi LTB, Rochester L, Alcock L, Pantall A. Reduced Gait Variability and Enhanced Brain Activity in Older Adults With Auditory Cues: A Functional Near-Infrared Spectroscopy Study. Neurorehabil Neural Repair. 2018 Nov;32(11):976-987. doi: 10.1177/1545968318805159.'}, {'pmid': '26410626', 'type': 'BACKGROUND', 'citation': "Vorovenci RJ, Biundo R, Antonini A. Therapy-resistant symptoms in Parkinson's disease. J Neural Transm (Vienna). 2016 Jan;123(1):19-30. doi: 10.1007/s00702-015-1463-8. Epub 2015 Sep 26."}, {'pmid': '28756732', 'type': 'BACKGROUND', 'citation': 'Yang N, Waddington G, Adams R, Han J. Translation, cultural adaption, and test-retest reliability of Chinese versions of the Edinburgh Handedness Inventory and Waterloo Footedness Questionnaire. Laterality. 2018 May;23(3):255-273. doi: 10.1080/1357650X.2017.1357728. Epub 2017 Jul 31.'}, {'pmid': '37438071', 'type': 'DERIVED', 'citation': "Fan W, Fong KNK, Wang SM. Effects of training involving patterned sensory enhancement on improving upper-limb movements in patients with Parkinson's disease: protocol of a randomised controlled trial. BMJ Open. 2023 Jul 12;13(7):e072416. doi: 10.1136/bmjopen-2023-072416."}]}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to examine effects of training involving rhythmic auditory stimulation (RAS) on upper-limb movements and functions in patients with Parkinson's disease (PD).\n\nThis study employed a 21-day randomized controlled trial design to evaluate the efficacy of upper-limb training involving RAS on upper-limb function and neural activity in PD patients. The RAS group showed sustained improvements at one-month follow-up.", 'detailedDescription': "This study employed a randomized controlled trial design. We randomly assigned PD patients into either the RAS group (experimental) or the noRAS group (control). Both groups underwent a 21-day training program (40 minutes per session, one session daily), with the only difference being the presence or absence of RAS. Assessments were conducted at five time points: baseline (T1), day 8 (T2), day 15 (T3), post-intervention (T4), and one-month follow-up (T5). Behavioral assessments were performed at all time points, while EEG recordings were only conducted at baseline (T1) and post-intervention (T4). All assessments and training sessions were scheduled during participants' medication 'on' state (1-2 hours after medication intake) to ensure consistency and optimal motor function."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* idiopathic PD diagnosed by a neurologist based on the Movement Disorders Society clinical diagnostic criteria;\n* the Hoehn and Yahr stage is 2 or 3, meaning that bilateral movement problems or combination with mild postural instability;\n* a score of Montreal Cognitive Assessment is equal to or higher than 21 to ensure that they understand experimental instructions;\n* a score of Edinburgh Handedness Inventory is above 60 to ensure that they are right-handed;\n* types and doses of medications remain unchanged in the past month right before participation.\n\nExclusion Criteria:\n\n* the presence of medical conditions or diseases that may affect hand movements, vision, or hearing based on self-report.'}, 'identificationModule': {'nctId': 'NCT05637593', 'briefTitle': 'Rhythmic Auditory Stimulation on Upper-limb Movements in PD Patients', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': "Effects of Training Involving Rhythmic Auditory Stimulation on Upper-limb Movements in Patients With Parkinson's Disease", 'orgStudyIdInfo': {'id': 'HongKongPU21037721r_20221117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the RAS group', 'description': 'The RAS group will receive upper-limb movement training with the aid of RAS;', 'interventionNames': ['Behavioral: Upper-limb movement training with the aid of RAS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'the no-RAS group', 'description': 'The no-RAS group will receive upper-limb movement training without the aid of RAS.', 'interventionNames': ['Behavioral: Upper-limb movement training without the aid of RAS']}], 'interventions': [{'name': 'Upper-limb movement training with the aid of RAS', 'type': 'BEHAVIORAL', 'description': 'Three target bowls, labeled as the left, middle, and right target bowl, will be placed on the table at an equal distance from the main bowl. The distance between a target bowl and the main bowl is set at 30 cm. Wooden beads with a diameter of 2 cm will be put in target bowls. The main bowl will be placed in front of the patient.\n\nPatients will be asked to listen to the RAS sound, use the right hand to take one bead at a time from the left target bowl to the main bowl, repeat this movement for the middle and right target bowls, and keep repeating this order. They should keep their movements consistent with the sound of the RAS, with one RAS sound corresponding to one pick-up movement.\n\nEach daily training will consist of three rounds separated by two 5-minute breaks. Each round will consist of four consecutive sessions (for each session: 2-minute training followed by a 30-second break). The training will last for a total of 21 days.', 'armGroupLabels': ['the RAS group']}, {'name': 'Upper-limb movement training without the aid of RAS', 'type': 'BEHAVIORAL', 'description': 'Three target bowls, labeled as the left, middle, and right target bowl, will be placed on the table at an equal distance from the main bowl. The distance between a target bowl and the main bowl is set at 30 cm. Wooden beads with a diameter of 2 cm will be put in target bowls. The main bowl will be placed in front of the patient.\n\nPatients will be asked to use the right hand to take one bead at a time from the left target bowl to the main bowl, repeat this movement for the middle and right target bowls, and keep repeating this order. They are asked to execute the task as fast as possible.\n\nEach daily training will consist of three rounds separated by two 5-minute breaks. Each round will consist of four consecutive sessions (for each session: 2-minute training followed by a 30-second break). The training will last for a total of 21 days.', 'armGroupLabels': ['the no-RAS group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wei FAN (PhD student), MSc', 'role': 'CONTACT', 'email': '21037721r@connect.polyu.hk', 'phone': '+825 67681229'}, {'name': 'Shu-Mei Wang (supervisor), PhD', 'role': 'CONTACT', 'email': 'shumei.wang@polyu.edu.hk', 'phone': '+852 27664197'}], 'overallOfficials': [{'name': 'Wei FAN (PhD student), MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'FAN Wei', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}