Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-27 @ 11:12 AM
Study NCT ID:
NCT04323267
Status:
COMPLETED
Last Update Posted:
2020-05-29
First Post:
2020-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Home-Exercise Therapy Application For Patients With Non-Surgical Knee Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D046788', 'term': 'Patellofemoral Pain Syndrome'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-27', 'studyFirstSubmitDate': '2020-03-23', 'studyFirstSubmitQcDate': '2020-03-24', 'lastUpdatePostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PROMIS Pain Score', 'timeFrame': '8 weeks', 'description': 'Pain is measured by 0-100. 0 = no pain and 100 = very high pain'}, {'measure': 'PROMIS Physical Function CAT', 'timeFrame': '8 weeks', 'description': 'Function is measured by 0-100. 0= no function and 100 = high function'}], 'secondaryOutcomes': [{'measure': 'Subject Satisfaction Questions', 'timeFrame': '8 weeks', 'description': 'Satisfaction questions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee pain', 'knee osteoarthritis', 'patellofemoral syndrome', 'physical therapy', 'digital health'], 'conditions': ['Knee Injuries', 'Knee Osteoarthritis', 'Patellofemoral Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Knee pain is one of the most prevalent musculoskeletal disorders in the United States. Conservative treatments generally consist of pharmacological agents and physical therapy. Unfortunately, such conservative care is often mismanaged, and little data is collected on clinical outcomes. The proposed investigation utilizes a novel and state-of-the-art mobile application (DETP) to guide an at-home exercise therapy program for non-operative knee pain. The purpose of this study is conducting a single-blind randomized, controlled, superiority study to compare the DETP to conventional physical therapy (PT). The investigators will seek to determine improvement in pain and function in PROMIS measures as the primary outcome. The investigators will also evaluate satisfaction with the application as a secondary outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75, inclusive.\n* Diagnosis of knee injury. For participants enrolled from the Mayo healthcare system database, knee injury identified from electronic medical records.\n* Pain Numerical Rating Scale score of 4 or greater on a 0-10 scale (0 = no pain, 10 = pain).\n* Participants must be diagnosed with a knee injury and the next step of care is either a home exercise program or external physical therapy ordered at the academic center.\n* Prescribed external physical therapy (i.e., therapy not completed at Mayo Clinic in Rochester/Minneapolis).\n\nExclusion Criteria:\n\n* No access to android or iPhone smartphone\n* BMI greater than or equal to 35\n* Previously completed series of physical therapy visits for knee injury within the past 12 months for the same injury (received one introduction PT session as seen in executive program will not be considered an exclusion).\n* Recommended by a physician for consideration of total knee replacement.\n* Diagnosis of rheumatoid arthritis, fibromyalgia, gout in the knee, or other systemic rheumatic disease.\n* Hospitalization for a stroke, heart attack, heart failure, or had surgery for blocked arteries in the past 12 months.\n* Total joint replacement knee surgery, bucket-handle meniscus tear, ACL tear, or other knee surgery in the past 12 months.\n* Unable to speak English.\n* Active diagnosis of psychosis.\n* Fall history deemed by a physician to impose risk for potential injury with participation in a home-based exercise program.\n* Severely impaired hearing or speech.'}, 'identificationModule': {'nctId': 'NCT04323267', 'briefTitle': 'Digital Home-Exercise Therapy Application For Patients With Non-Surgical Knee Injuries', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Efficacy of Digital Home-Exercise Therapy Application For Patients With Non-Surgical Knee Injuries: A Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': '19-007031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital Home Exercise Program', 'description': 'Limber Digital Application Device (3 x a week for 8 weeks)', 'interventionNames': ['Device: Limber Digital Application']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physical therapy', 'description': 'Therapy prescription 2 x a week for 8 weeks (specified by physician)', 'interventionNames': ['Behavioral: Physical therapy Therapy']}], 'interventions': [{'name': 'Limber Digital Application', 'type': 'DEVICE', 'description': 'A mobile application was recently developed to address these needs. The application provides evidence-based, symptom specific home-exercise video programs for MSK conditions, as well as clinically-validated outcome measures for tracking progress.', 'armGroupLabels': ['Digital Home Exercise Program']}, {'name': 'Physical therapy Therapy', 'type': 'BEHAVIORAL', 'description': 'Therapy prescription 2 x a week for 8 weeks (specified by physician)', 'armGroupLabels': ['Physical therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Jacob Sellon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jacob L. Sellon, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}