Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT06011018
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2023-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Effects of Mirror Therapy Combined With Neuromuscular Electrical Stimulation or Binaural Beats Stimulation on Cortical Excitability, Heart Rate Variability and Lower Limb Motor Function in Patients With Stroke
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': 'D000088762', 'term': 'Mirror Movement Therapy'}, {'id': 'D004558', 'term': 'Electric Stimulation'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly assigned treatment groups:\n\n1. Mirror Therapy\n2. Mirror Therapy + Electrical Stimulation\n3. Mirror Therapy + Binaural Beat'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2023-08-21', 'studyFirstSubmitQcDate': '2023-08-21', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Electroencephalography', 'timeFrame': '20minutes', 'description': 'Electroencephalography is used obtain power data of total μ (8-12Hz), lower μ (8-10Hz), and upper μ (10-12Hz).\n\nμ suppression→ a negative value (\\<0) indicates inhibition of μ waves, indicating activation in the motor cortex(Bae et al., 2012).'}], 'primaryOutcomes': [{'measure': 'Fugl-Meyer assessment, lower extremity', 'timeFrame': '10minutes', 'description': 'The Fugl-Meyer Assessment for lower extremity is a scale used to evaluate motor and functional recovery in patients with conditions like stroke. It measures muscle strength, movement control, coordination, and balance. Scores range from 0 (no movement) to 34 (full recovery). Higher scores indicate better recovery.'}], 'secondaryOutcomes': [{'measure': 'Modified ashworth scale', 'timeFrame': '5minutes', 'description': 'The Modified Ashworth Scale assesses muscle spasticity in conditions like stroke or cerebral palsy. Scores range from 0 to 4 or 5, indicating the severity of muscle resistance during passive movement. Higher scores mean more severe spasticity. It guides treatment and tracks progress.'}, {'measure': 'Timed up and go test', 'timeFrame': '5minutes', 'description': "The Timed Up and Go (TUG) test assesses mobility by measuring the time it takes for someone to stand, walk a short distance, turn, and sit back down. Faster times suggest better mobility, while longer times may indicate mobility limitations or fall risk. It's a useful tool to evaluate functional capacity and guide interventions for improved mobility."}, {'measure': 'The postural assessment scale for stroke patients', 'timeFrame': '10 minutes', 'description': 'Higher scores on the Postural Assessment Scale for Stroke Patients (PASS) indicate greater difficulty in postural control and stability after a stroke.'}, {'measure': 'Barthel index', 'timeFrame': '5minutes', 'description': "The Barthel Index assesses a person's ability to independently perform daily activities. Scores range from 0 to 100, with higher scores indicating greater independence."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Healthy Adults']}, 'descriptionModule': {'briefSummary': "This study aims to compare the effects of mirror therapy combined with either neuromuscular electrical stimulation or binaural beat stimulation on post-stroke lower limb motor function recovery. The study also explores the relationship between patients' cortical excitability and motor function improvement."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. First occurrence of stroke≧ 6 months\n2. Mini-mental state examination≧24\n3. Modified Ashworth's scale of ankle muscle ≦3\n4. Sit independently≧30 mins\n5. Brunnstrom stage ≧3\n6. Aged between 20 and 80 years\n\nExclusion Criteria:\n\n1. Speech impairment\n2. Hearing impairment\n3. Visual impairment\n4. Other orthopedic diseases or nerve damage\n5. Complete sensory impairment\n6. Pacemaker or metal implants"}, 'identificationModule': {'nctId': 'NCT06011018', 'briefTitle': 'Comparison of Effects of Mirror Therapy Combined With Neuromuscular Electrical Stimulation or Binaural Beats Stimulation on Cortical Excitability, Heart Rate Variability and Lower Limb Motor Function in Patients With Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Comparison of Effects of Mirror Therapy Combined With Neuromuscular Electrical Stimulation or Binaural Beats Stimulation on Cortical Excitability, Heart Rate Variability and Lower Limb Motor Function in Patients With Stroke', 'orgStudyIdInfo': {'id': 'KMUHIRB-F(II)-20220175'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mirror therapy', 'interventionNames': ['Other: Mirror Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Mirror Therapy + Electrical Stimulation', 'interventionNames': ['Other: Mirror Therapy + Electrical Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Mirror Therapy + Binaural Beat', 'interventionNames': ['Other: Mirror Therapy + Binaural Beat']}], 'interventions': [{'name': 'Mirror Therapy', 'type': 'OTHER', 'description': 'Sitting, mirror place at the midline between the legs. Unaffected leg is placed in front of the mirror and perform ankle dorsiflexion exercises.\n\nDuration: 5 seconds, Rest: 5 seconds', 'armGroupLabels': ['Mirror therapy']}, {'name': 'Mirror Therapy + Electrical Stimulation', 'type': 'OTHER', 'description': 'Same as the mirror therapy protocol. Affected leg: electrical stimulation on tibialis anterior muscle. Frequency: 35 Hz, Pulse width: 250µs, Duration: 5 seconds, Rest: 5 seconds.', 'armGroupLabels': ['Mirror Therapy + Electrical Stimulation']}, {'name': 'Mirror Therapy + Binaural Beat', 'type': 'OTHER', 'description': 'Same as the mirror therapy protocol. Listen to music (pink noise), with 14Hz binaural beat stimulation', 'armGroupLabels': ['Mirror Therapy + Binaural Beat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'LIN JAU HONG, Ph.D.', 'role': 'CONTACT', 'email': 'jhlin@kmu.edu.tw', 'phone': '0929393300'}, {'name': "LIN YEN YU, Master's", 'role': 'CONTACT', 'email': 'yenyu.lin88@yahoo.com', 'phone': '0988392631'}], 'facility': 'Kaohsiung Medical University, Department of Physical Therapy', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'LIN JAU HONG, Ph.D.', 'role': 'CONTACT', 'email': 'jhlin@kmu.edu.tw', 'phone': '0929393300'}, {'name': "LIN YEN YU, Master's degree", 'role': 'CONTACT', 'email': 'yenyu.lin88@yahoo.com', 'phone': '0988392631'}], 'overallOfficials': [{'name': 'LIN JAU HONG, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Kaohsiung Medical University,department of Physical Therapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'During the study period, to ensure subject privacy, only the implementers of this research project, monitors, regulatory authorities, and the institutional review board of our institution have the authority to access the data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}