Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT02937532
Status:
COMPLETED
Last Update Posted:
2019-01-15
First Post:
2016-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fear of Falling in Patients With Chronic 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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-14', 'studyFirstSubmitDate': '2016-10-17', 'studyFirstSubmitQcDate': '2016-10-17', 'lastUpdatePostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Chinese version of the Activities-specific Balance Confidence scale (ABC-C)', 'timeFrame': '2 years', 'description': 'The ABC-C be used to assess the level of fear of falling. The ABC-C consisted of 16 items reflecting the level of balance confidence from 0% (no confidence) to 100% (complete confidence)'}], 'secondaryOutcomes': [{'measure': 'The Chinese version of the Lawton Instrumental Activities of Daily Living scale (IADL-C)', 'timeFrame': '2 years', 'description': 'The IADL-C will be used to assess the ability of participants to live independently at home and community. The IADL-C included 9 items rating on a 3-point scale ranging from 0 to 18. Higher score indicates better performance.'}, {'measure': 'The Chinese version of the Community Integration Measure (CIM-C)', 'timeFrame': '2 years', 'description': 'The CIM-C consisted of 10 items soliciting on a 5-point scale in which the higher the score indicating the higher level of community integration.'}, {'measure': 'The Chinese version of the Short Form General Health Questionnaire (SF-36-C)', 'timeFrame': '2 years', 'description': 'The SF-36-C will be used to measure the health-related quality of life. It consisted of 2 scales, the physical health summary and mental health summary, rating on a two- to six-point Likert scale ranging from 0 to 100 each subscale. The higher the score indicating the higher level of health-related quality of life.'}, {'measure': 'The Chinese version of the Survey of Activities and Fear of Falling in the Elderly (SAFFE-C)', 'timeFrame': '2 years', 'description': 'The SAFFE-C will be used to assessed the level of fear avoidance behavior. It consisted of 22 items rating on a 4-point Likert scale ranging from 0 to 66. Lower score indicates less fear avoidance behaviors.'}, {'measure': 'Berg Balance Scale', 'timeFrame': '2 years', 'description': 'The BBS to assess the clinical balance. It consisted of 14 items with scoring from 0 to 56. The higher the score indicates the better balance performance.'}, {'measure': 'The Short-form Physiological Profile Assessment (S-PPA)', 'timeFrame': '2 years', 'description': 'The S-PPA will be used to assess the fall risk ranging from -2 to 4. The higher the score represents the lower the fall risk.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fear of falling', 'Fear avoidance behavior', 'cognitive behavioral therapy', 'Rehabilitation'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '30580723', 'type': 'DERIVED', 'citation': 'Liu TW, Ng GYF, Chung RCK, Ng SSM. Decreasing Fear of Falling in Chronic Stroke Survivors Through Cognitive Behavior Therapy and Task-Oriented Training. Stroke. 2019 Jan;50(1):148-154. doi: 10.1161/STROKEAHA.118.022406. Epub 2018 Dec 7.'}, {'pmid': '29514677', 'type': 'DERIVED', 'citation': 'Liu TW, Ng GYF, Ng SSM. Effectiveness of a combination of cognitive behavioral therapy and task-oriented balance training in reducing the fear of falling in patients with chronic stroke: study protocol for a randomized controlled trial. Trials. 2018 Mar 7;19(1):168. doi: 10.1186/s13063-018-2549-z.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate whether combining cognitive-behavioral therapy (CBT) with task-oriented balance training (TOBT) is more effective than general health education (GHE) together with TOBT in promoting fear of falling and reducing activity avoidance behavior.', 'detailedDescription': 'The null hypothesis of this study will be that no significant difference in the efficacy of the two treatments (CBT + TOBT; GHE + TOBT) in promoting fear of falling and reducing fear avoidance behavior, and thus no significant difference in improving balance ability, reducing fall risks, improving health-related quality of life and community reintegration of people with stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria: Subjects will be included if they\n\n* are between 55 and 85 years of age;\n* have been diagnosed with a first unilateral ischemic brain injury or intracerebral hemorrhage by magnetic resonance imaging or computed tomography within the previous 1 to 6 years;\n* have been discharged from all rehabilitation services at least 6 months before program begins;\n* are able to work independently at least 10 meters with or without an assistive device;\n* have low balance self-efficacy (The Activities-specific Balance Confidence scale score of \\<80);\n* are able to score \\> 7 out of 10 on the Chinese version of Abbreviated Mental Test; and\n* are able to follow instructions and provide written informed consent.\n\nExclusion criteria: Subjects will be excluded if they\n\n* have any additional medical, cardiovascular, orthopaedic, or psychiatric or psychological condition that would hinder proper treatment or assessment;\n* have receptive dysphasia;\n* have significant lower peripheral neuropathy; or\n* are involved in a drug studies or other clinical trial.'}, 'identificationModule': {'nctId': 'NCT02937532', 'briefTitle': 'Fear of Falling in Patients With Chronic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Effects of Combining Cognitive Behavioural Therapy With Task-oriented Balance Training for Reducing Fear of Falling in People With Chronic Stroke: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SM_Ng'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'GHE + TOBT training', 'description': 'Subjects will receive general health education and task-oriented balance training.', 'interventionNames': ['Behavioral: GHE + TOBT training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CBT + TOBT training', 'description': 'Subjects will receive group-based cognitive behavioral therapy and task-oriented balance training.', 'interventionNames': ['Behavioral: CBT + TOBT training']}], 'interventions': [{'name': 'GHE + TOBT training', 'type': 'BEHAVIORAL', 'description': 'All subjects will receive 45 minutes of GHE, followed by 45 minutes of TOBT program twice a week for 8 weeks.', 'armGroupLabels': ['GHE + TOBT training']}, {'name': 'CBT + TOBT training', 'type': 'BEHAVIORAL', 'description': 'All subjects will receive 45 minutes of CBT, followed by 45 minutes of TOBT program twice a week for 8 weeks.', 'armGroupLabels': ['CBT + TOBT training']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hung Hom', 'country': 'Hong Kong', 'facility': 'The Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.30715, 'lon': 114.18532}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Shamay Ng', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}