Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04079205
Status:
TERMINATED
Last Update Posted:
2021-09-27
First Post:
2019-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Home Rehabilitation Using Smart Wearable Exercise and Electrical Stimulation Device After Anterior Cruciate Ligament Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Due to difficulty in patient enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-20', 'studyFirstSubmitDate': '2019-05-08', 'studyFirstSubmitQcDate': '2019-09-02', 'lastUpdatePostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quadriceps muscle strength using dynamometry', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Change from baseline quadriceps muscle strength at 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Active range of motion of knee', 'timeFrame': 'Baseline, 2 weeks and 6 weeks', 'description': 'Change from baseline active range of motion of knee at 2 weeks and 6 weeks'}, {'measure': 'Passive range of motion of knee', 'timeFrame': 'Baseline, 2 weeks and 6 weeks', 'description': 'Change from baseline passive range of motion of knee at 2 and 6 weeks'}, {'measure': 'Root mean square of surface electromyography of quadriceps muscle', 'timeFrame': 'Baseline, 2 weeks and 6 weeks', 'description': 'Change from baseline root mean square of surface electromyography of quadriceps muscle at 2 weeks and 6 weeks'}, {'measure': 'International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score', 'timeFrame': 'Baseline, 2 weeks and 6 weeks', 'description': 'Changes from baseline in International Knee Documentation Committee (IKDC) subjective score at 2 weeks and 6 weeks, Higher scores indicate better recovery'}, {'measure': 'Lysholm score', 'timeFrame': 'Baseline, 2 weeks and 6 weeks', 'description': 'Change from baseline in Lysholm score at 2 weeks and 6 weeks. Lysholm score ranges from 0-100 with higher scores indicating better knee joint function.'}, {'measure': 'Knee Outcome Survey-Activities of Daily Living Scale', 'timeFrame': 'Baseline, 2 weeks and 6 weeks', 'description': 'Change from baseline in score of Knee Outcome Survey-Activities of Daily Living Scale at 2 weeks and 6 weeks. Score ranges from 0-100 with higher scores indicating better knee joint function.'}, {'measure': 'EQ-5D-3L Scores', 'timeFrame': 'Baseline, 2 weeks and 6 weeks', 'description': 'Change from baseline in EQ-5D-3L Scores at 2 weeks and 6 weeks. EQ-5D-3L is made up for two components. First, the health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension ranging from 1-3. From these five dimensions, EQ-5D index is calculated, having a value between 0-1. Second, the evaluation part involves an analogue scale, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. Zero corresponds to " the worst health you can imagine", and hundred corresponds to "the best health you can imagine".'}, {'measure': 'Visual Analogue Scale for pain', 'timeFrame': 'Baseline, 2 weeks and 6 weeks', 'description': 'Change from baseline in Visual Analogue Scale at 2 weeks and 6 weeks. The Visual Analogue Scale(VAS), a 101-point scale for evaluating pain which consists of a 100-millimetre scale ranging from 0 (no pain at all) to 100 (worst imaginable pain).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anterior Cruciate Ligament Reconstruction', 'Wearable device', 'Knee', 'Neuromuscular Electrical Stimulation', 'Exercise'], 'conditions': ['Anterior Cruciate Ligament Reconstruction']}, 'referencesModule': {'references': [{'pmid': '32443364', 'type': 'DERIVED', 'citation': 'Kim G, Kim WS, Kim TW, Lee YS, Lee H, Paik NJ. Home-based rehabilitation using smart wearable knee exercise device with electrical stimulation after anterior cruciate ligament reconstruction: A study protocol for a randomized controlled trial. Medicine (Baltimore). 2020 May;99(20):e20256. doi: 10.1097/MD.0000000000020256.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop and apply a rehabilitation program for patients who are discharged after ACL reconstruction using a wearable joint rehabilitation exercise device (exoRehab).', 'detailedDescription': 'This randomized, single-blind, controlled trial included 40 patients who are discharged after ACL reconstruction.\n\nThe intervention group(n=20) was instructed and educated about 6 week home rehabilitation program using a wearable device(exoRehab)\n\nThe controls(n=20) was instructed and educated about 6 week conventional home rehabilitation program\n\nTwo weeks after surgery and six weeks after discharge, evaluation is performed.\n\nThe purpose of this study is to develop and apply a rehabilitation program for patients who are discharged after ACL reconstruction using a wearable joint rehabilitation exercise device (exoRehab).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with anterior cruciate ligament reconstruction\n* Patients who are older than 19 years of age\n\nExclusion Criteria:\n\n* History of surgery or traumatic injury to the uninvolved lower extremity\n* Complication after ACL reconstruction surgery\n* Dermatological conditions affecting the thigh\n* Body mass index (BMI) greater than 40 kg/m2\n* Implanted pacemakers or defibrillators\n* Significant neurologic impairments\n* Other unstable lower-extremity orthopedic conditions\n* Initiated rehabilitation at another facility prior to their first physical therapy session at our facility\n* Other lower limb impairment affecting function\n* More than one surgery for a tear of the ACL'}, 'identificationModule': {'nctId': 'NCT04079205', 'briefTitle': 'Home Rehabilitation Using Smart Wearable Exercise and Electrical Stimulation Device After Anterior Cruciate Ligament Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Home-based Rehabilitation Using Smart Wearable Knee Exercise Device With Electrical Stimulation After Anterior Cruciate Ligament Reconstruction: A Study Protocol for a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'B-1806-475-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home rehabilitation using Wearable Device', 'description': 'Home rehabilitation using Wearable Device(exoRehab)', 'interventionNames': ['Device: Wearable Device(exoRehab)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Standard home rehabilitation program', 'interventionNames': ['Behavioral: Home rehabilitation program']}], 'interventions': [{'name': 'Wearable Device(exoRehab)', 'type': 'DEVICE', 'description': 'rehabilitation program for patients after Anterior Cruciate Ligament Reconstruction using Wearable Device (exoRehab)', 'armGroupLabels': ['Home rehabilitation using Wearable Device']}, {'name': 'Home rehabilitation program', 'type': 'BEHAVIORAL', 'description': 'rehabilitation program for patients after Anterior Cruciate Ligament Reconstruction', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Nam-Jong Paik, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital, Seongnam, South Korea'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of SMEs and Startups, Korea', 'class': 'UNKNOWN'}, {'name': 'Exosystems CO.,Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nam-Jong Paik', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}