Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-01-01 @ 2:49 PM
Study NCT ID:
NCT05751161
Status:
COMPLETED
Last Update Posted:
2023-03-10
First Post:
2023-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Gait Training With Auditory Stimuli on Balance, Gait & Funtional Independence in 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-08', 'studyFirstSubmitDate': '2023-02-20', 'studyFirstSubmitQcDate': '2023-02-20', 'lastUpdatePostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Berg balance scale', 'timeFrame': '6 weeks', 'description': 'To identify the effect of treatment on dynamic balance. The BBS consists of 14 items scored on a 5 point ordinal scale , ramging from 0-4 ..0 means unable to sit without support .4 means able to sit independently.'}], 'secondaryOutcomes': [{'measure': 'Barthel index', 'timeFrame': '6 weeks', 'description': 'it is an ordinal scale that measures functional independence in the domain of personal care and mobility.'}, {'measure': 'Gait speed', 'timeFrame': '6 weeks', 'description': 'it is the time one takes to walk a specific distance on level surface over a short distance. A distance of 3 to 10 meters is measured over a level surface with 2 meters acceleration and 2 meter for decleration'}, {'measure': 'POMA', 'timeFrame': '6 weeks', 'description': 'It evaluates dynamic balance and walking patters.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '28744049', 'type': 'BACKGROUND', 'citation': 'Park MH, Won JI. The effects of task-oriented training with altered sensory input on balance in patients with chronic stroke. J Phys Ther Sci. 2017 Jul;29(7):1208-1211. doi: 10.1589/jpts.29.1208. Epub 2017 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'To determine the effect of gait training with auditory stimuli on dynamic balance, gait and functional independence on chronic stroke.', 'detailedDescription': 'The purpose of this study is to find the effect of gait training with auditory stimuli using a smart phone metronome application on dynamic balance, gait and functional abilities of chronic stroke patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* both gender\n* Age between 30-70\n* More than 6 months after the stroke\n* Able to walk more than 10 meters independently\n* MMSE score of 24\n\nExclusion Criteria:\n\n* Dependent gait\n* Aphasia\n* Any hearing or visual defects\n* Moderate to severe cognitive disorder\n* People not willing to participtae'}, 'identificationModule': {'nctId': 'NCT05751161', 'briefTitle': 'Effect of Gait Training With Auditory Stimuli on Balance, Gait & Funtional Independence in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effect of Gait Training With Auditory Stimuli on Dynamic Balance, Gait and Functional Independence in Chronic Stroke', 'orgStudyIdInfo': {'id': 'REC/RCR & AHS/22/0211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'effect of gait training with AS on dynamic balance, gait and functional independence in stroke', 'description': 'Patients with chronic stroke receive gait training with auditory stimuli to improve dynamic balance, gait and functional independence.', 'interventionNames': ['Other: conventional gait training']}, {'type': 'OTHER', 'label': 'effect of conventional gait training on dynamic balance, gait and functional independence in stroke', 'description': 'Patients in this group receive conventional gait training only to improve dynamic balance, gait and functional independence .Patients did not receive auditory stimuli for gait training.', 'interventionNames': ['Other: conventional gait training']}], 'interventions': [{'name': 'conventional gait training', 'type': 'OTHER', 'otherNames': ['Gait training with auditory stimuli'], 'description': 'The experimental group received circuit gait training with auditory stimuli using a smartphone metronome application. The training program consisted of eight different activities i.e. tandem walk, one-leg standing, military march, sitting up and forward walk, lateral walk, kicking a ball towards the wall, walking on a set pattern and obstacle walk .Patient will practice each task for 3-4 mints and three times per week.', 'armGroupLabels': ['effect of conventional gait training on dynamic balance, gait and functional independence in stroke', 'effect of gait training with AS on dynamic balance, gait and functional independence in stroke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52544', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Pakistan society for the rehabilitation of disabled', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'maria samad', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}, {'name': 'fatima tariq', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}