Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-04 @ 10:29 AM
Study NCT ID:
NCT00498758
Status:
UNKNOWN
Last Update Posted:
2007-07-10
First Post:
2007-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The APOS System: Effects on Gait, Mobility and QOL in Patients With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D051346', 'term': 'Mobility Limitation'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-07', 'completionDateStruct': {'date': '2008-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-07-09', 'studyFirstSubmitDate': '2007-07-09', 'studyFirstSubmitQcDate': '2007-07-09', 'lastUpdatePostDateStruct': {'date': '2007-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gait characteristics', 'timeFrame': '3 monthes'}, {'measure': 'Quality of life', 'timeFrame': '3 monthes'}, {'measure': 'Mobility', 'timeFrame': '3 monthes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Gait Disturbances', 'Mobility', 'Quality of life'], 'conditions': ["Idiopathic Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the benefits of a biomechanical wedge system - The APOS system, for improving the stability of gait, mobility and quality of life in Parkinson's disease patients.", 'detailedDescription': 'Recently, a biomechanical wedge system was developed for gait and balance training among patients suffering from gait disorders. The APOS system (APOS Medical \\& Sports Technologies Ltd, Hertzeliya, Israel) applies special semispherical shoes, with individually adjusted implants, to improve age- and disease-related loss in muscle strength and neuromuscular control. The semispherical rubber devices that are placed on the soles of the shoes at the hind-foot and mid-foot can be moved medially, laterally, forwards and backwards. The system can be individually adjusted in order to optimally balance loading and re-train postural control during gait. An additional advantage of this treatment approach is the extraordinary compliance. The system is easily adjusted, maintained, and allows safe gait training.\n\nAfter randomization, all subjects will be fitted with the APOS system, These shoes alter the dynamic balance during all gait cycle phases, adjusting the center of gravity and training postural control.\n\nThe precise location of the two wedges is adjusted individually by expert trainers using standardized protocols. Subjects in the intervention group will receive a proper wedge; subjects in the sham group will receive an almost flat wedge that lacks the proper biomechanical characteristics. However, both shoes and wedges will look similar. All subjects will be instructed to start gradually, with a goal of reaching 30 minutes of in-home walking while wearing the special training shoes. As an extra pre-caution, all subjects will be asked to walk with the shoes only in the presence of a caregiver, spouse or other family member during the first month. Before moving to more independent training, subjects will be checked for safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Idiopathic Parkinson's disease\n* Stage 2-3 Hoehn \\& Yahr\n\nExclusion Criteria:\n\n* Peripheral neuropathic pain\n* Dementia\n* Severe orthopaedic condition\n* c.v.a\n* Hearing or vision loss\n* Usage of walking aid"}, 'identificationModule': {'nctId': 'NCT00498758', 'briefTitle': "The APOS System: Effects on Gait, Mobility and QOL in Patients With Parkinson's Disease", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'orgStudyIdInfo': {'id': 'tasmc-07-ng-152-ctil'}}, 'armsInterventionsModule': {'interventions': [{'name': 'APOS System - biomechanical wedge shoe', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Talia Herman', 'role': 'CONTACT', 'email': 'talit@tasmc.health.gov.il'}, {'name': 'Yael Rotem-Galili', 'role': 'CONTACT', 'email': 'rotem.yael@gmail.com'}], 'overallOfficials': [{'name': 'Nir Giladi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Movement Disorders Unit - Tel Aviv Sourasky medical center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}}}}