Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-02-25 @ 7:05 PM
Study NCT ID:
NCT02333994
Status:
COMPLETED
Last Update Posted:
2015-01-08
First Post:
2015-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Education With Balance Exercise in Improving Balance and Reducing the Fear of Falls in Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-07', 'studyFirstSubmitDate': '2015-01-01', 'studyFirstSubmitQcDate': '2015-01-07', 'lastUpdatePostDateStruct': {'date': '2015-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BERG BALANCE SCALE', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'ACTIVITY BALANCE CONFIDENCE SCALE', 'timeFrame': '6 WEEKS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Distorted; Balance']}, 'referencesModule': {'references': [{'pmid': '39360568', 'type': 'DERIVED', 'citation': 'Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study was to evaluate the Efficacy of Education With Balance Exercise in Reducing Fear of Falls in Elderly Population . In the present study the educational program along with balance training was delivered to group A, (Experimental group) and only Balance training was delivered to group B, (Control group) for 6 weeks for 1 hr duration once weekly. Education program included education about the risk factors of falls such as environmental hazards, importance of good nutrition, use of stick while walking, avoiding slippery surfaces. Balance training consists of stance activities and balance exercise program. The outcome measures for this intervention were Activities specific balance confidence scale and berg balance scale.', 'detailedDescription': 'Present study was an experimental design. A total of 60 elderly subjects were selected as per the selection criteria and they were randomly allocated in two equal groups i.e.Group A- (Experimental Group)- Balance Exercises and Education Program Group B - (Control Group) - Balance exercises.procedure of study was explained to each subject and written consent was taken from them.\n\nAim:\n\nThe aim of the study was to evaluate the Efficacy of Education With Balance Exercise in Reducing Fear of Falls in Elderly Population .\n\nMaterials and Methods In the present study the educational program along with balance training was delivered to group A, (Experimental group) and only Balance training was delivered to group B, (Control group) for 6 weeks for 1 hr duration once weekly. Education program included education about the risk factors of falls such as environmental hazards, importance of good nutrition, use of stick while walking, avoiding slippery surfaces. Balance training consists of stance activities and balance exercise program. The outcome measures for this intervention were Activities specific balance confidence scale and berg balance scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elderly\n* Both males and females were included in the study.\n* Individuals with Mini Mental Status Examination score \\>23.\n* History of falls in last 6 months\n\nExclusion Criteria:\n\n* Any musculoskeletal disorder\n* Any visual deficit\n* Any systemic disease\n* Any Neurological Disorder\n* Any Cardiovascular and Respiratory Disorder\n* Now cooperative Individuals\n* Any Psychological disorder'}, 'identificationModule': {'nctId': 'NCT02333994', 'briefTitle': 'Efficacy of Education With Balance Exercise in Improving Balance and Reducing the Fear of Falls in Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Maharishi Markendeswar University (Deemed to be University)'}, 'officialTitle': 'Efficacy of Education With Balance Exercise in Improving Balance and Reducing the Fear of Falls in Elderly', 'orgStudyIdInfo': {'id': 'D3456'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GROUP A', 'description': 'EDUCATION PROGRAMME AND BALANCE TRAINING EXERCISES', 'interventionNames': ['Device: GROUP A education programme as well as balance training exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GROUP B', 'description': 'BALANCE EXERCISES', 'interventionNames': ['Other: GROUP B on-platform training']}], 'interventions': [{'name': 'GROUP A education programme as well as balance training exercises', 'type': 'DEVICE', 'description': 'Group A received education programme as well as balance training exercises.The intervention group attended one-hour training classes once a week for 6 consecutive weeks. The classes involved both lectures and discussions and were guided through with handouts and worksheets. Each session began by giving a summary of the previous session and continued with the main topic of the session. The intervention program also engaged the participants in discussions about their concerns regarding falling and on topics pertaining to identifying and reducing the risk factors of falls, including environmental hazards in and out of the house', 'armGroupLabels': ['GROUP A']}, {'name': 'GROUP B on-platform training', 'type': 'OTHER', 'otherNames': ['BALANCE TRAINING'], 'description': 'on-platform training was performed while standing and while sitting on a 22-inch therapeutic ball, 1 eyes open or closed 2 normal or reduced area of foot support 3 on foam or floor 4 with or without manual p', 'armGroupLabels': ['GROUP B']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'DIVYA MIDHA, MPT(NEURO)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MAHARISHI MARKANDESHWAR UNIVERSITY'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maharishi Markendeswar University (Deemed to be University)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSISTANT PROFESSOR', 'investigatorFullName': 'DIVYA MIDHA', 'investigatorAffiliation': 'Maharishi Markendeswar University (Deemed to be University)'}}}}