Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-30 @ 10:01 PM
Study NCT ID:
NCT03302832
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2017-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Reduced Frequency Physical Therapy in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-23', 'studyFirstSubmitDate': '2017-09-22', 'studyFirstSubmitQcDate': '2017-10-04', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': 'Pre-surgery to 3 months post-surgery', 'description': 'The KOOS measurement is a patient-reported questionnaire that contains 42 questions covering 5 categories (pain, symptoms, activities of daily living, sports and recreation, and quality of life'}], 'secondaryOutcomes': [{'measure': 'Self-reported home exercise compliance/adherence', 'timeFrame': '1 month post-surgery, 2 months post-surgery, 3 months post-surgery', 'description': 'Basic questions regarding the percent compliance with home exercises, amount of exercise time per week, and amount of days the participant performed exercise each week.'}, {'measure': 'Change in Knee Active Range of Motion (AROM)', 'timeFrame': 'Pre-surgery to 3 months post-surgery', 'description': 'Measurement of the range of motion that the participant can perform (in degrees) when maximally bending and straightening the knee.'}, {'measure': 'Change in Knee Passive Range of Motion (PROM)', 'timeFrame': 'Pre-surgery to 3 months post-surgery', 'description': "Measurement of the range of motion (in degrees) that the participant's knee can maximally bend and straighten as a result of a manually applied movement."}, {'measure': 'Change in Timed Up-and-Go Test (TUG)', 'timeFrame': 'Pre-surgery to 3 months post-surgery', 'description': 'The TUG is a physical performance test that consists of the participant rising from a chair, ambulating 9 meters, turning around, returning to the chair and sitting. It is recorded in seconds.'}, {'measure': 'Change in 6-minute Walk Test (6MWT)', 'timeFrame': 'Pre-surgery to 3 months post-surgery', 'description': 'The 6MWT is an assessment of longer duration ambulation and cardiorespiratory endurance. The test measurement is the total amount of distance that the participant ambulates within a 6-minute period.'}, {'measure': 'Change in 30 second Chair Stand Test (30s-CST)', 'timeFrame': 'Pre-surgery to 3 months post-surgery', 'description': 'The 30s-CST is a test of strength, endurance and functional balance. The maximum number of sit to stand repetitions performed over a 30 second period represents the score for this test. Pre-test positioning includes placement of a 44 cm (17 inch) chair, measured from floor to seat surface, against a wall to inhibit movement of the chair during the test.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total Knee Arthroplasty', 'Total Knee Replacement'], 'conditions': ['Knee Osteoarthritis', 'Knee Arthritis', 'Knee Arthropathy']}, 'descriptionModule': {'briefSummary': 'Rehabilitation after Total Knee Arthroplasty surgery involves physical therapy services to address limitations in range of motion, strength, and participation in normal daily activities. This investigation will compare the outcomes from standard physical therapy intervention in comparison to reduced frequency physical therapy sessions supplemented with in-home exercise equipment.', 'detailedDescription': "Total knee arthroplasty (TKA) is a common surgical procedure for individuals experiencing pain and reduced physical abilities related to knee pain, most commonly osteoarthritis. Common physical impairments associated with post-operative TKA rehabilitation include: reduced knee range of motion (ROM), reduced strength, reduced participation in activities of daily living, and pain. TKA surgery is routinely paired with physical therapy (PT) interventions post-operatively in order to facilitate recovery for patients electing to undergo this intervention. The Total Range Exerciser (T-REX) is a medical device aimed at reducing the need for post-operative physical therapy services while promoting outcomes.\n\nA successful outcome after total knee arthroplasty requires symptom relief and restoration of physical function. Measurement of pain and function can be achieved through patient-reported outcomes measures and objective functional testing. The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a patient-reported outcomes measure intended to capture the individual patient's perception of progress throughout the rehabilitative process. Objective measurements of physical function are necessary to quantify the magnitude of physical impairment associated with the patient's perceived status. Physical function can be measured through standardized assessment of knee ROM, strength, and ambulation. The purpose of this study is to evaluate the effectiveness of standard physical therapy compared to reduced frequency physical therapy supplemented with the (T-REX) after in total knee arthroplasty in subjective and objective measurements of physical function."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individual is to undergo TKA by a licensed physician at Participating hospital group\n* Participating primary health insurance provider\n* Patient is \\< 64.5 years of age\n* Willingness to participate in study protocol\n\nExclusion Criteria:\n\n* Previous or current history of cancer\n* High risk for cardiovascular disease as determined by the American College of Sports Medicine\n* Individuals with documented mental, psychiatric, or emotional disabilities\n* Inability to read and write in English'}, 'identificationModule': {'nctId': 'NCT03302832', 'briefTitle': 'Effectiveness of Reduced Frequency Physical Therapy in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Campbell University, Incorporated'}, 'officialTitle': 'Effectiveness of Reduced Frequency Physical Therapy Supplemented With In-home Exercise Equipment Compared to Standard Care Physical Therapy in Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '313'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care Physical Therapy', 'description': 'The participants randomized to the Standard Care Physical Therapy group will begin outpatient physical therapy services after discharge from inpatient care, on day 4 or 5 post-Total Knee Arthroplasty. The frequency of sessions will be 2-3 x per week for the initial 2 weeks, followed by 2 x per week until the culmination of physical therapy. The frequency and duration of sessions will be determined by the treating physical therapist based upon the clinical needs and progress of the specific participant.', 'interventionNames': ['Other: Physical Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Physical Therapy and in-Home Equipment', 'description': 'The participants randomized to the experimental group will begin outpatient physical therapy services after discharge from inpatient care, on day 4 or 5 post-Total Knee Arthroplasty. The frequency of physical therapy sessions will be 1 x per week throughout the duration of the study period. In addition, this group will utilize in-home exercise equipment daily.', 'interventionNames': ['Other: Physical Therapy', 'Other: In-home Exercise Equipment']}], 'interventions': [{'name': 'Physical Therapy', 'type': 'OTHER', 'description': 'Physical therapy includes both the in-person and home-based interventions prescribed for each individual participant in order to maximize overall patient outcomes including: ambulation, range of motion, strength, functional activities, pain, swelling, balance, patient safety, and other items within the scope of physical therapy practice.', 'armGroupLabels': ['Physical Therapy and in-Home Equipment', 'Standard Care Physical Therapy']}, {'name': 'In-home Exercise Equipment', 'type': 'OTHER', 'otherNames': ['Total Range Exerciser Arc', 'T-REX Arc'], 'description': 'The in-home exercise component of the study will supplement physical therapy services. This exercise equipment will be utilized daily for up to 90 minutes as guided by the healthcare team', 'armGroupLabels': ['Physical Therapy and in-Home Equipment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'EmergeOrtho', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Bradley Myers, PT, DPT, DSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No data is intended to be shared with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Campbell University, Incorporated', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Bradley Myers', 'investigatorAffiliation': 'Campbell University, Incorporated'}}}}