Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT00268658
Status:
UNKNOWN
Last Update Posted:
2007-02-27
First Post:
2005-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Use of Andante SmartStep System in Gait Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D005265', 'term': 'Femoral Neck Fractures'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D025981', 'term': 'Hip Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-11', 'lastUpdateSubmitDate': '2007-02-26', 'studyFirstSubmitDate': '2005-12-21', 'studyFirstSubmitQcDate': '2005-12-21', 'lastUpdatePostDateStruct': {'date': '2007-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'load bearing over the affected lower limb'}, {'measure': 'quality/symmetry of gait'}, {'measure': 'level of ambulation and physical independence'}]}, 'conditionsModule': {'keywords': ['Arthroplasty, Replacement, Hip', 'Arthroplasty, Replacement, Knee', 'Arthroscopy'], 'conditions': ['Ankle Injuries', 'Femoral Neck Fractures']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of the biofeedback gait training device in improving load bearing over an operated limb, during post-operative gait training therapy. The effectiveness of the device will also be tested in self-training at home.', 'detailedDescription': 'To evaluate the effectiveness of the biofeedback gait training device as a biofeedback training therapeutic tool in improving body-weight bearing over the affected lower limb, quality of gait, level of ambulation and physical independence during rehabilitation, in patients after orthopedic procedures during gait therapy training, and as a biofeedback device for self-training at home.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rehabilitation after operation\n* Patient is allowed full weight bearing\n* Patient is motivated and able to communicate and understands orders\n* Patient is able to walk 10 meters\n* Patient filled out agreement and consent form\n\nExclusion Criteria:\n\n* Activity limitation due to medical disorder, medications, or emotional status.\n* Pain markedly obstructs gait ability\n* Documented peripheral neuropathy\n* Functional limitation prior to the current condition\n* Premorbid, ongoing major depression or psychosis\n* Multiple/pathological fractures\n* Serious early complications\n* Terminally ill patients\n* Pregnant women\n* Participation in current or recent (within 60 days prior to surgery) clinical trial'}, 'identificationModule': {'nctId': 'NCT00268658', 'briefTitle': 'Clinical Use of Andante SmartStep System in Gait Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'Clinical Use of Andante SmartStep System in Gait Rehabilitation', 'orgStudyIdInfo': {'id': 'sor412805ctil'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SmartStep(tm) biofeedback device', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Beersheba', 'country': 'Israel', 'contacts': [{'name': 'Daniel Plotkin, MD', 'role': 'CONTACT', 'email': 'ctrials@gmail.com', 'phone': '972-507-633433'}], 'facility': 'Soroka University Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'overallOfficials': [{'name': 'Daniel Plotkin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soroka University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}}}}