Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT04037059
Status:
COMPLETED
Last Update Posted:
2022-05-17
First Post:
2019-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Body Habitus (Arm Span and Abdominal Girth) on Activities of Daily Living (ADL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-13', 'studyFirstSubmitDate': '2019-07-25', 'studyFirstSubmitQcDate': '2019-07-25', 'lastUpdatePostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Quality of Life as measured by Oswestry Disability Index (ODI)', 'timeFrame': 'Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months', 'description': '10 question survey that rates disability from low, moderate, to severe disability'}, {'measure': 'Change in Quality of Life as measured by Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months', 'description': '4 question survey that rates pain'}, {'measure': 'Change in Quality of Life as measured by EQ-5D', 'timeFrame': 'Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months', 'description': 'Survey that looks at 5 different components activities of daily living'}, {'measure': 'Change in Quality of Life as measured by Scoliosis Research Society (SRS) Form', 'timeFrame': 'Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months', 'description': '22 or 30 question survey that rates scoliosis'}, {'measure': 'Change in Quality of Life as measured by Lumbar Stiffness Disability Index (LSDI) Form', 'timeFrame': 'Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months', 'description': 'Survey that rates lumbar stiffness'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Activities of Daily Living (ADL)', 'Complex Spinal Fusion'], 'conditions': ['Spinal Fusion', 'Activities of Daily Living Following Complex Spinal Fusions']}, 'descriptionModule': {'briefSummary': 'This study is being done to assess the impact of arm length and abdominal (belly) width on patient performance of daily self-care activities following multiple level spinal fusions. The study will also assess if the number of levels operated on in the spinal fusion procedure affects your ability to perform Activities of Daily Living (ADL) and how long after surgery do the difficulties/limitations persist.', 'detailedDescription': 'This is a prospective, single-center study of adult patients undergoing long segment spinal fusions to the pelvis (\\>5 levels).\n\nHealth Related Quality of Life Outcome (HRQOL) consisting of the Oswestry Disability Index (ODI), Visual Analog Scale, EQ-5D, Scoliosis Research Society-22 and 30 (SRS-22 and SRS-30) and the Lumbar Stiffness Disability Index (LSDI) will be collected preoperatively, 6 weeks, 3 months, 6 months, 12 and 24 months. All measures will be collected during clinic visits.\n\nPrimary and secondary objectives The primary objective is to determine the impact of body habitus on postoperative ADLs in patients undergoing long segment spinal fusions.\n\nThe secondary objective will be to determine if the number of levels of fusions impact the ability to perform ADLs and to study how long after surgery do the difficulties/limitations persist.\n\nStudy procedures Enrolled subjects meeting eligibility criteria and provide consent will be approached by the study coordinator and explained the purpose of the study, risks and benefits to participation, and queried about their interest in participation. Patients consenting to the study will have the following measurements performed by the clinician with an evaluation prior to surgery, during their 6 week, 3 month, 6 month, 12 and 24 month postoperative visits.\n\n1. Waist circumference using a measuring tape will be obtained from midway between the last ribs and the iliac crest as suggested by the World Health Organization and the International Diabetes Federation.\n2. The arm span (wingspan) or reach will be measured. To measure the arm span, the patient will be asked to stand against the wall with their arms extended sideways at a ninety-degree angle. Using a measuring tape, the distance from the tip of the middle finger of one hand to the tip of the middle finger in other arm will be measured and recorded.\n3. The distance from the ground to the tip of middle finger will be measured while the patient is asked to touch their toes with knees fully extended.\n\nAs mentioned, all study patients will complete Health Related Quality of Life Outcome (HRQOL) consisting Oswestry Disability Index (ODI), Visual Analog Scale, EQ-5D, Scoliosis Research Society-22 (SRS-22) and the Lumbar Stiffness Disability Index (LSDI) at 6 weeks, 3 months, 6 month, 12 and 24 months.\n\nData will be collected in a password-protected file and will be stored in an electronically secure environment, as specified in the research data security plan (RDSP).\n\nFollow-up by the research coordinator as part of this study will not necessarily preclude or replace any follow-up by the treating physician or nursing staff as part of the routine standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are seeking evaluation and treatment at the Duke Spine Center and have been recommended to undergo spine surgery will be approached by the treating surgeon and/or the study coordinator about the study.\n\nThe goal enrollment is 256 patients within 1 year.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults18 to 80 years old\n2. Spinal fusion surgery involving thoracolumbar spine \\> 5 levels\n3. Ability to stand to obtain arm span, abdominal girth and ability to bend at the waist to obtain measurement\n\nExclusion Criteria:\n\n1. Patients who are incarcerated, paraplegic or unable to return for follow-up visits\n2. Patients with prior lumbar fusions at the indicated levels for surgery\n3. Spinal fusion surgery involving thoracolumbar \\< 5 levels\n4. Patients who already have lumbopelvic fixation with iliac screws'}, 'identificationModule': {'nctId': 'NCT04037059', 'acronym': 'ADL', 'briefTitle': 'Impact of Body Habitus (Arm Span and Abdominal Girth) on Activities of Daily Living (ADL)', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Impact of Body Habitus (Arm Span and Abdominal Girth) on Activities of Daily Living (ADL) in Patients Undergoing Long Segment Deformity Surgery: A Prospective Study', 'orgStudyIdInfo': {'id': 'Pro00101177'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spinal Deformity Patients', 'description': "For patients with disabling spinal deformities, long segment fusions have been shown to improve the health related quality of life (HRQOL). A consequence of spine fusion however is elimination of range of motion especially in the lumbar spine. Even in patients who report overall improvement in pain related domains, difficulty with some ADL's in this patient group has been well documented in previous studies. Complaints such as inability to dress independently, bathing of lower halves of their body, driving a motor vehicle, getting in and out of a chair/bed and performing perineal hygiene care following toileting have been reported."}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Isaac Karikari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}