Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-26 @ 6:40 AM
Study NCT ID:
NCT06696950
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-20
First Post:
2024-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Gait Training With and Without Rhythmic Auditory Stimulation in Chronic Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-12-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2024-11-18', 'studyFirstSubmitQcDate': '2024-11-18', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LOWER EXTREMITY MOTOR COORDINATON TEST (LEMCOT)', 'timeFrame': '6 weeks', 'description': 'The Lower Extremity Motor Coordination test (LEMCOT) is a clinically useful performance-based test to assess coordination improvements of lower limb in post-stroke individuals'}, {'measure': 'Dynamic gait index (DGI)', 'timeFrame': '6 weeks', 'description': 'The dynamic gait index is a comprehensive clinical assessment performance based tool used designed to evaluate gait-related task such as dynamic balance, gait and risk of fall in older adults with various neurological conditions'}, {'measure': 'Fall Efficacy Scale-International (FES-I)', 'timeFrame': '6 weeks', 'description': 'Fall efficacy scale-international (FES- I) is a standardized, short and easy to administer tool evaluates fear of falling and measures concerns about falling'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Stroke', 'Gate Training', 'Multimodal', 'Rhythmic auditory stimulation'], 'conditions': ['Chronic Stroke Patients']}, 'descriptionModule': {'briefSummary': 'The primary goal of this randomized clinical trial is to investigate the efficacy of multimodal gait training, with and without rhythmic auditory stimulation, in improving gait, coordination and reducing fall risk in individuals with chronic stroke This clinical trial features two distinct groups 42 participants were randomly divided into two groups of 21. Group A will receive Multimodal gait training along with rhythmic auditory stimulation while Group B will receive only multimodal gait training\n\nParticipants will:\n\n* Take 12 sessions of the MMGT program over six weeks\n* With each session lasting 45 minutes, including 10-minute rest breaks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants of age between 45 and 70 year\n* Participants of both genders were included.\n* Participants who were able to walk independently indoors without walking aid\n* Participants were included if they had lower limb motor impairment (Fugl-Meyer Assessment lower extremity (FMLE) score less than score less than 34\n* Participants with stroke lasting longer than six months\n* Participants with Mini-Mental Status Examination score 24 or more than 24\n* Participants with the capability to keep in sitting position for 30 minutes\n* Participants with the history of fall in the past year\n* Participants with no visual or auditory impairments that would interfere with the training\n\nExclusion Criteria:\n\n* Participants with respiratory problems.\n* Participants with any orthopedic condition.\n* Participants with aphasia that impeded communication.\n* Participants with have severe cardiac disease.\n* Participants with resistant hypertension despite use of medication (average systolic blood pressure ≥ 140 mmHg or average diastolic blood pressure ≥ 90 mmHg measured over 7 days)\n* Participants with presence of non-healing ulcers in the lower limbs, and osteoporosis'}, 'identificationModule': {'nctId': 'NCT06696950', 'briefTitle': 'Multimodal Gait Training With and Without Rhythmic Auditory Stimulation in Chronic Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Multimodal Gait Training With and Without Rhythmic Auditory Stimulation on Coordination, Gait and Risk of Fall in Chronic Stroke Patients', 'orgStudyIdInfo': {'id': 'REC/RCR&AHS/24/0202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Group A received Multimodal gait training with Rhythmic auditory stimulation', 'interventionNames': ['Other: Mutimodal gait training includes unilateral step training, inclined treadmill training, over ground training with rhythmic auditory stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Group B Multimodal Gait training without rhythmic auditory stimulation', 'interventionNames': ['Other: Multimodal gait training']}], 'interventions': [{'name': 'Mutimodal gait training includes unilateral step training, inclined treadmill training, over ground training with rhythmic auditory stimulation', 'type': 'OTHER', 'description': 'Unilateral step training, inclined treadmill training, over ground training, repetitive isochronous pulses via metronome', 'armGroupLabels': ['Group A']}, {'name': 'Multimodal gait training', 'type': 'OTHER', 'description': 'Unilateral step training, inclined treadmill training, over ground training,', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51040', 'city': 'Sialkot', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Allama Iqbal Memorial Hospital, Islam teaching hospital, National Bone joint Hospital, Amra Medical Center', 'geoPoint': {'lat': 32.49268, 'lon': 74.53134}}], 'overallOfficials': [{'name': 'Binish Afzal, MS-NMPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}