Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 4:07 PM
Study NCT ID:
NCT00601133
Status:
COMPLETED
Last Update Posted:
2013-01-10
First Post:
2008-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Function and Balance for Inpatient Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-09', 'studyFirstSubmitDate': '2008-01-14', 'studyFirstSubmitQcDate': '2008-01-24', 'lastUpdatePostDateStruct': {'date': '2013-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Results of functional tests of postural control (Timed 50 feet walk + Timed Get Up & Go Test)', 'timeFrame': 'Observation points at baseline (discharge) and at post discharge week 4 +/- 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Solid Tumors', 'Acute Inpatient Rehabilitation', 'Postural Instability', 'Balance', 'Function', 'Walking', 'Questionnaire', 'Survey'], 'conditions': ['Solid Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'The University of Texas M.D.Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'Objectives:\n\nPrimary Objectives:\n\nTo determine the change in functional tests of postural control of cancer patients who have completed acute inpatient rehabilitation or complete rehabilitation through mobile team from discharge at 21-60 days (+/- 3) after discharge.\n\nSecondary Objectives:\n\nTo assess the correlations between the functional tests of postural control, the balance test and the amount of exercise per week.', 'detailedDescription': 'To be enrolled in this study, you must be able to walk with or without an assistant device (such as a cane or a walker).\n\nStudy Procedures:\n\nIf you are found to be eligible to take part in this study, you will do a combination of walking and balance tests twice, once on the day you leave the rehabilitation center or hospital, and again at a return visit 21-60 days (+/-3) later. For the first test, you will get up from a chair and walk 10 feet as quickly, but as safely, as possible. You will then return to the chair and sit again. For the second test, you will walk 25 feet, turn around, and walk back to the starting point as fast and as safely as you can. Both tests will be timed by the study staff.\n\nYou will also do a balance test on a machine. You will stand on a platform with a rail to hold on to. You will shift your weight and try to keep your balance and center of gravity, which will be shown on a screen.\n\nYou will be given a diary to record any physical exercise you are doing from the time you leave the rehabilitation center to your return visit 21-60 days (+/-3) later. You will be asked to record what kind of exercises (home exercise, home health therapy, or outpatient therapy treatment) you do and for how many hours. It should take about 5 minutes to fill out the diary each time.\n\nYou will complete a questionnaire that asks you about your symptoms, such as pain. You will complete it when you leave the rehabilitation program and again at the study visit 21-60 days (+/-3) later. It should take about 5 minutes to complete the questionnaire.\n\nLength of Study:\n\nYou will be off study after you complete the second questionnaire.\n\nThis is an investigational study.\n\nUp to 58 patients will take part in this study. All will be enrolled at M. D. Anderson.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have completed acute inpatient rehabilitation at MDACC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients, or the legal guardians of patients, must have the ability to understand and willingness to sign a written informed consent document.\n2. Patients must be able to ambulate with or without assistant device, without assistance from a person.\n3. Patients must have undergone acute inpatient rehabilitation at MDACC or undergone rehabilitation through mobile team.\n\nExclusion Criteria:\n\n1. Patients who decline to participate or who are determined incapable of completing the research.\n2. Active CNS disease, such as clinically-evident metastases or leptomeningeal disease, dementia, or encephalopathy.\n3. Patient who is not willing or able to come back for 4+/-1 week routine follow-up.'}, 'identificationModule': {'nctId': 'NCT00601133', 'briefTitle': 'Function and Balance for Inpatient Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Quantitative and Clinical Description of Postural Instability in Patient Who Underwent Acute Inpatient Rehabilitation and at Follow-Up', 'orgStudyIdInfo': {'id': '2007-0799'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient Postural Instability', 'description': 'Participants having difficulty walking and with balance after cancer treatment that are leaving the M.D. Anderson rehabilitation hospital or after treatment through the rehabilitation mobile team.', 'interventionNames': ['Other: Walking Test', 'Other: Balance Test', 'Behavioral: Questionnaire', 'Behavioral: Diary']}], 'interventions': [{'name': 'Walking Test', 'type': 'OTHER', 'description': 'Timed Test 1: From sitting position walk 10 feet quickly, return to sitting position Timed Test 2: Walk 25 feet, turn around, and walk back\n\nTests conducted twice, once on departure from rehabilitation center, and again at a return visit 1 month later', 'armGroupLabels': ['Patient Postural Instability']}, {'name': 'Balance Test', 'type': 'OTHER', 'description': 'Machine balance test: Stand on a platform with a rail, shift weight and try to maintain balance and center of gravity; Results displayed.', 'armGroupLabels': ['Patient Postural Instability']}, {'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'otherNames': ['Survey'], 'description': 'To be completed when leaving the rehabilitation program and again at the study visit 1 month later, lasting about 5 minutes.', 'armGroupLabels': ['Patient Postural Instability']}, {'name': 'Diary', 'type': 'BEHAVIORAL', 'otherNames': ['journal'], 'description': 'Record any physical exercise done from departure of rehabilitation center to return visit 1 month later; includes exercises; approximately 5 minutes per entry', 'armGroupLabels': ['Patient Postural Instability']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Ying Guo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}