Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT01439451
Status:
COMPLETED
Last Update Posted:
2015-08-06
First Post:
2011-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Perturbation Training on Balance Control in Elderly Persons
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-05', 'studyFirstSubmitDate': '2011-09-11', 'studyFirstSubmitQcDate': '2011-09-22', 'lastUpdatePostDateStruct': {'date': '2015-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'voluntary and compensatory step execution times in miliseconds', 'timeFrame': 'change from baseline to 3 months later', 'description': 'the time from perturbation to foot contact the floor completing the recovary stepping will be measured in miliseconds'}], 'secondaryOutcomes': [{'measure': 'postural sway parameters such as mediolateral sway in milimeters and elliptical area in milimeters squeres', 'timeFrame': "Time 1: pre test' and 3 months later time 2: post testing procedure", 'description': 'body sway will be measured to evaluate control of posture'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Balance control', 'Aging', 'Balance reactions', 'Perturbation', 'above seventy years old'], 'conditions': ['Accidental Falls']}, 'referencesModule': {'references': [{'pmid': '32689965', 'type': 'DERIVED', 'citation': 'Batcir S, Shani G, Shapiro A, Alexander N, Melzer I. The kinematics and strategies of recovery steps during lateral losses of balance in standing at different perturbation magnitudes in older adults with varying history of falls. BMC Geriatr. 2020 Jul 20;20(1):249. doi: 10.1186/s12877-020-01650-4.'}, {'pmid': '32069450', 'type': 'DERIVED', 'citation': 'Nachmani H, Shani G, Shapiro A, Melzer I. Characteristics of First Recovery Step Response following Unexpected Loss of Balance during Walking: A Dynamic Approach. Gerontology. 2020;66(4):362-370. doi: 10.1159/000505649. Epub 2020 Feb 18.'}, {'pmid': '26944706', 'type': 'DERIVED', 'citation': 'Kurz I, Gimmon Y, Shapiro A, Debi R, Snir Y, Melzer I. Unexpected perturbations training improves balance control and voluntary stepping times in older adults - a double blind randomized control trial. BMC Geriatr. 2016 Mar 4;16:58. doi: 10.1186/s12877-016-0223-4.'}]}, 'descriptionModule': {'briefSummary': 'The proposed project is a prospective experimental Randomized Control Trial study design. Independent old adults (age 70 years old and older) who do not suffer from balance problems willing to participate in the study will be tested before and after Peturbation balance training during walking to explore whether there are differences in balance control and balance reactions as a result of training.', 'detailedDescription': 'A total of 48 old adults will be enrolled, evaluated and trained. They will be randomly assigned to two groups: one exercise group (perturbation training) and one group without perturbation. No gender based differences are expected for the recovery outcome measures so we will be able to pool male and female individuals for this analysis. Each subject of the experimental and of the control groups will be trained on 24 occasions over a period of 10-12 weeks (20-30 minutes, 2-3 times/week). This regimen was based on previous balance training study that demonstrated improvements in balance control with similar training duration and frequency. Gait and balance function and physical activity level will be tested in both groups before, immediately after, 3 and 6 months after completion of the training period to explore the benefit and carryover of training. In addition using monthly phone calls, falls, their severity, functional activity limitations in the home and community setting and health status will be monitored 12 months after the training period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be 70 years or older, male or female\n* Be an independent ambulator (not cane or walker) and provide medical waiver from MD.\n\nExclusion Criteria:\n\n* Severe focal muscle weakness or paralysis, after Total Hip or knee arthroplasty\n* Moderate-severe dementia (Mini-Mental Score \\< 24).\n* Serious visual impairment\n* Severe peripheral or compression/entrapment neuropathies.\n* Symptomatic orthostatic hypotension, respiratory, cardiovascular, musculoskeletal, or neurological disorders that may interfere with participation in the exercise program.\n* Cancer, metastatic or under active treatment.'}, 'identificationModule': {'nctId': 'NCT01439451', 'acronym': 'BaMPer', 'briefTitle': 'Effect of Perturbation Training on Balance Control in Elderly Persons', 'organization': {'class': 'OTHER', 'fullName': 'Barzilai Medical Center'}, 'officialTitle': 'Effect of Balance Perturbation to Improve Gait and Balance Control and Prevent Falls in Elderly Persons -A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'BARZI1729'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental', 'description': 'perturbation training during walking', 'interventionNames': ['Procedure: perturbation training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'controls', 'description': 'treadmill walking', 'interventionNames': ['Procedure: perturbation training']}], 'interventions': [{'name': 'perturbation training', 'type': 'PROCEDURE', 'otherNames': ['treadmill walking', 'perturbation training during walking'], 'description': 'The experimental and control groups will participate in 3 month training program twice a week 20 minutes each training session', 'armGroupLabels': ['controls', 'experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84105', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Ben-Gurion University of the Negev', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'city': 'Beersheba', 'country': 'Israel', 'facility': 'Beit Yona', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'overallOfficials': [{'name': 'Ronen Debi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Barzilai Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barzilai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'IRB Coordinator', 'investigatorFullName': 'Ornit Cohen', 'investigatorAffiliation': 'Barzilai Medical Center'}}}}