Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-31 @ 6:27 PM
Study NCT ID:
NCT04228159
Status:
UNKNOWN
Last Update Posted:
2020-01-14
First Post:
2020-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perturbation Training Compared to Balance and Strengthening Exercise, for Elderly at Risk of Falling
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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized control trial. Older adults at moderate and high risk of falling will be recruited among Clalit patients referred to one of three physical therapy clinics, or other clinics nearby, neither by physician referral due to gait abnormality or following the physiotherapist diagnosis. Potential participants fulfilling the inclusion criteria and not meeting the exclusion criteria will sign informed consent and continue with baseline assessment. Those not wishing to participate will continue with routine care. Once the baseline assessment is completed, participants will be randomized into one of two intervention groups using computer random allocation software. Participants in both groups will attend physical therapy clinics twice a week for a total of 14 sessions. Each session will last 30 minutes. General information regarding fall prevention will be delivered to all participants using Clalit brochures and electronic prescriptions'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2022-05-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-13', 'studyFirstSubmitDate': '2020-01-13', 'studyFirstSubmitQcDate': '2020-01-13', 'lastUpdatePostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of falls and fallers', 'timeFrame': 'falls and fallers rates during 12-months following end of treatment'}, {'measure': 'hip fractures and hospitalizations rates due to falls', 'timeFrame': 'hip fractures and hospitalizations rates due to falls during12-months following end of treatment'}], 'secondaryOutcomes': [{'measure': 'Mini-BESTest', 'timeFrame': 'end of treatment-last visit in physical therapy clinic', 'description': 'Balance assessment according to Balance Evaluation Systems Test. The Mini-BESTest is a 14 item test scored on a 3-level ordinal scale. The total score is 28 while a lower score indicates severe balance impairment'}, {'measure': 'Activities-Specific Balance Confidence Scale (ABC scale)', 'timeFrame': '12 months after end of treatment', 'description': 'The ABC scale is a 16-item self-report measure in which patients rate their balance confidence for performing activities. Items are rated on a rating scale that ranges from 0-100; 0 represents "no confidence" and 10 represents "complete confidence".'}, {'measure': 'Physical Activity Scale for the Elderly (PASE)', 'timeFrame': '12 months after end of treatment', 'description': 'The PASE measures the level of self-reported physical activity in individuals aged 65 years or older and is comprised of items regarding occupational, household, and leisure activities during the previous 7-days period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Accidental Falls, Frail Elderly, Physical Therapy Specialty'], 'conditions': ['Fall Prevention']}, 'descriptionModule': {'briefSummary': 'One third of adults over 65 and 50% of adults above 80 years old fall at list once a year. In some cases, falls result in fractures, hospitalization, functional limitations, depression, morbidity and mortality. Strong evidence support exercise training programs for fall prevention, while several studies examined the effect of perturbation training on risk of fall. The aim of this study is to evaluate the effectiveness of a perturbation training program with unexpected perturbation using balance tutor on falls and injuries among elderly at risk of falling, compared to balance and strengthening exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:at least one fall during the last 12 months; age 65-85; mini-mental state examination score 24 and above allowing cognitive ability to understand simple instructions ; Time Up and Go (TUG), assessing balance, walking ability and fall risk, scored 13 and above ; ability to read Hebrew or Arabic; and the ability to walk independently 10 meters.\n\n\\-\n\nExclusion Criteria:progressive neurological conditions (Parkinson, Multiple sclerosis, CVA); severe orthopedic conditions including lower limb or spine fractures and surgeries in the past 12 months prior to baseline; blindness; Arrhythmia; uncontrolled chronic disease (i.e., hypertension, diabetes, ischemic heart disease); diagnosed severe osteoporosis with a history of fracture during the past 3 years prior to baseline; active cancer during the past three years prior to baseline; lack of availability in the coming two months for completing the treatment protocol\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04228159', 'briefTitle': 'Perturbation Training Compared to Balance and Strengthening Exercise, for Elderly at Risk of Falling', 'organization': {'class': 'OTHER', 'fullName': 'Clalit Health Services'}, 'officialTitle': 'The Effectiveness of Perturbation Training With Balance Tutor, Compared to Balance and Strengthening Exercise, on Falls Rate Among Elderly at Risk of Falling', 'orgStudyIdInfo': {'id': 'fall prevention BT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Perturbation training', 'description': 'Session1 - baseline assessment (detailed above) Session2 - 13 - each session will begin with reassessment and documentation of balance tutor parameters for each participant as were calibrated at the end of previous session.\n\nAfter reassessment the training program will include:\n\n* Warm up - walking without perturbation.\n* Perturbation during standing position.\n* Perturbation during walking.\n* Perturbation during tandem position.\n* Perturbation with vestibular stimulation.\n* Rest according to patient needs The relative duration of each component, as well as intensity and frequency of perturbations, will be adjusted to each individual according to his ability, reassessment parameters and progression.\n\nSession14 - full reassessment of all baseline examinations including: Mini-BESTest, ABC scale, PASE, and number of falls.', 'interventionNames': ['Device: Balance Tutor Biofeedback Rehabilitation System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Balance and strengthening exercise', 'description': 'Session1 - baseline assessment (detailed above).\n\nSession2 - 13 - each session will include:\n\n* Warm up (free walking or cycling).\n* Static balance exercise - standing position. Exercise will be performed using different bases of support (narrow, tandem, and one leg stance), eyes open/closed, unstable surfaces, functional and cognitive dual task, and vestibular stimulation.\n* Dynamic balance exercise - walking position. Exercise will be performed using different bases of support (narrow, tandem, and one leg stance), eyes open/closed, unstable surfaces, functional and cognitive dual task, and vestibular stimulation.\n* Strengthening exercise - general strengthening, particularly for lower limb.\n* Cool down. Level of difficulty and duration of each component will be adjusted to each individual according to his ability and progression.\n\nSession14 - full reassessment of all baseline examinations including: Mini-BESTest, ABC scale, PASE, and number of falls.', 'interventionNames': ['Other: Balance and strengthening exercise']}], 'interventions': [{'name': 'Balance Tutor Biofeedback Rehabilitation System', 'type': 'DEVICE', 'description': 'Balance Tutor system is a unique technology which allows for several postural control ability assessments as well as reactive response training in both standing and walking using controlled perturbation in simple task or multitask performance. Together with proactive training the system allows for optimal rehabilitation outcome and recovery', 'armGroupLabels': ['Perturbation training']}, {'name': 'Balance and strengthening exercise', 'type': 'OTHER', 'description': 'exercise training programs for fall prevention including walking and balance exercises, functional tasks, strength, flexibility and endurance', 'armGroupLabels': ['Balance and strengthening exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beersheba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Anat Shashua, PhD', 'role': 'CONTACT', 'email': 'Anatsh6@clalit.org.il', 'phone': '972508803223'}, {'name': 'Igal Levran, MHA BPT', 'role': 'CONTACT', 'email': 'ilevran@clalit.org.il', 'phone': '972506262223'}], 'facility': 'Clalit HealthCare services', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'city': 'Holon', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Anat Shashua, PhD', 'role': 'CONTACT', 'email': 'Anatsh6@clalit.org.il', 'phone': '972508803223'}, {'name': 'Igal Levran, MHA BPT', 'role': 'CONTACT', 'email': 'ilevran@clalit.org.il', 'phone': '972506262223'}], 'facility': 'Clalit Healthcare Services', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}, {'city': 'Nazareth', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Anat H Shashua, PhD', 'role': 'CONTACT', 'email': 'Anatsh6@clalit.org.il', 'phone': '972508803223', 'phoneExt': '972508803223'}, {'name': 'Igal H Levran, MHA BPT', 'role': 'CONTACT', 'email': 'ilevran@clalit.org.il', 'phone': '972506262223', 'phoneExt': '972508803223'}], 'facility': 'Clalit HealthCare Services', 'geoPoint': {'lat': 32.70087, 'lon': 35.29719}}], 'centralContacts': [{'name': 'Anat Shashua, PhD', 'role': 'CONTACT', 'email': 'Anatsh6@clalit.org.il', 'phone': '972-50-8803223'}, {'name': 'Igal Levran, MHA BPT', 'role': 'CONTACT', 'email': 'ilevran@clalit.org.il', 'phone': '972-50-6262223'}], 'overallOfficials': [{'name': 'Shlomit Yaron, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clalit Health Services'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clalit Health Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'MediTouch Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}