Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:16 AM
Study NCT ID:
NCT05001594
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2021-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wearable Vibration Effect on Biomechanics and Biomarkers After ACL Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-10', 'studyFirstSubmitDate': '2021-07-22', 'studyFirstSubmitQcDate': '2021-08-05', 'lastUpdatePostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower limb joints range of motion (Degrees)', 'timeFrame': 'Pre-surgery', 'description': 'Measured by Inertial measurement unit system'}, {'measure': 'Lower limb joints range of motion (Degrees)', 'timeFrame': '2 months post op', 'description': 'Measured by Inertial measurement unit system'}, {'measure': 'Lower limb joints range of motion (Degrees)', 'timeFrame': '4 months post op', 'description': 'Measured by Inertial measurement unit system'}, {'measure': 'Lower limb joints range of motion (Degrees)', 'timeFrame': '6 months post op', 'description': 'Measured by Inertial measurement unit system'}, {'measure': 'Knee strength (Newtons)', 'timeFrame': 'Pre-surgery', 'description': 'Non injured knee, quadriceps and hamstring'}, {'measure': 'Knee strength (Newtons)', 'timeFrame': '14 days post op', 'description': 'Non injured knee, quadriceps and hamstring'}, {'measure': 'Knee strength (Newtons)', 'timeFrame': '2 months post op', 'description': 'Non injured knee, quadriceps and hamstring'}, {'measure': 'Knee strength (Newtons)', 'timeFrame': '4 months post op', 'description': 'Non injured knee, quadriceps and hamstring'}, {'measure': 'Knee strength (Newtons)', 'timeFrame': '6 months post op', 'description': 'Non injured knee, quadriceps and hamstring'}, {'measure': 'Knee strength (Newtons)', 'timeFrame': 'Pre-surgery', 'description': 'Injured knee, quadriceps and hamstring'}, {'measure': 'Knee strength (Newtons)', 'timeFrame': '4 months post op', 'description': 'Injured knee, quadriceps and hamstring'}, {'measure': 'Knee strength (Newtons)', 'timeFrame': '6 months post op', 'description': 'Injured knee, quadriceps and hamstring'}, {'measure': 'The International Knee Documentation Committee (IKDC) Subjective Knee Form', 'timeFrame': 'Pre-surgery', 'description': 'The IKDC total score ranges from 0 to 100, where 100 indicates the highest levels of function and lowest levels of symptoms and 0 indicates the lowest level of function or highest level of symptoms.'}, {'measure': 'The International Knee Documentation Committee (IKDC) Subjective Knee Form', 'timeFrame': '14 days post op', 'description': 'The IKDC total score ranges from 0 to 100, where 100 indicates the highest levels of function and lowest levels of symptoms and 0 indicates the lowest level of function or highest level of symptoms.'}, {'measure': 'The International Knee Documentation Committee (IKDC) Subjective Knee Form', 'timeFrame': '2 months post op', 'description': 'The IKDC total score ranges from 0 to 100, where 100 indicates the highest levels of function and lowest levels of symptoms and 0 indicates the lowest level of function or highest level of symptoms.'}, {'measure': 'The International Knee Documentation Committee (IKDC) Subjective Knee Form', 'timeFrame': '4 months post op', 'description': 'The IKDC total score ranges from 0 to 100, where 100 indicates the highest levels of function and lowest levels of symptoms and 0 indicates the lowest level of function or highest level of symptoms.'}, {'measure': 'The International Knee Documentation Committee (IKDC) Subjective Knee Form', 'timeFrame': '6 months post op', 'description': 'The IKDC total score ranges from 0 to 100, where 100 indicates the highest levels of function and lowest levels of symptoms and 0 indicates the lowest level of function or highest level of symptoms.'}, {'measure': 'General Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'Pre-surgery', 'description': 'The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety'}, {'measure': 'General Anxiety Disorder-7 (GAD-7)', 'timeFrame': '14 days post op', 'description': 'The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety'}, {'measure': 'General Anxiety Disorder-7 (GAD-7)', 'timeFrame': '2 months post op', 'description': 'The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety'}, {'measure': 'General Anxiety Disorder-7 (GAD-7)', 'timeFrame': '4 months post op', 'description': 'The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety'}, {'measure': 'General Anxiety Disorder-7 (GAD-7)', 'timeFrame': '6 months post op', 'description': 'The GAD-7 total score ranges from 0 to 21, where 21 represents high anxiety and 0 indicates no anxiety'}, {'measure': 'Tampa Scale of Kinesiophobia (TSK)', 'timeFrame': 'Pre-surgery', 'description': 'The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia'}, {'measure': 'Tampa Scale of Kinesiophobia (TSK)', 'timeFrame': '14 days post op', 'description': 'The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia'}, {'measure': 'Tampa Scale of Kinesiophobia (TSK)', 'timeFrame': '2 months post op', 'description': 'The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia'}, {'measure': 'Tampa Scale of Kinesiophobia (TSK)', 'timeFrame': '4 months post op', 'description': 'The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia'}, {'measure': 'Tampa Scale of Kinesiophobia (TSK)', 'timeFrame': '6 months post op', 'description': 'The TSK total score ranges from 17 to 68, where 68 represents high kinesiophobia and 17 indicates no kinesiophobia'}], 'secondaryOutcomes': [{'measure': 'Single-leg hop for distance (cm)', 'timeFrame': '4 months post op', 'description': 'Functional assessment'}, {'measure': 'Single-leg hop for distance (cm)', 'timeFrame': '6 months post op', 'description': 'Functional assessment'}, {'measure': 'Single-leg drop jump (cm)', 'timeFrame': '4 months post op, 6 months post op', 'description': 'Functional assessment'}, {'measure': 'Single-leg drop jump (cm)', 'timeFrame': '6 months post op', 'description': 'Functional assessment'}, {'measure': 'Serum Biomarkers (ng/mL)', 'timeFrame': '4 months post op', 'description': '30-minute walk on a treadmill. change in concentration before and after the walk'}, {'measure': 'Surface Electromyography (EMG)', 'timeFrame': 'Pre-surgery', 'description': 'Surface EMG assessment of the quadriceps'}, {'measure': 'Surface EMG', 'timeFrame': '2 months post op', 'description': 'Surface EMG assessment of the quadriceps'}, {'measure': 'Surface EMG', 'timeFrame': '4 months post op', 'description': 'Surface EMG assessment of the quadriceps'}, {'measure': 'Surface EMG', 'timeFrame': '6 months post op', 'description': 'Surface EMG assessment of the quadriceps'}, {'measure': 'Surface EMG', 'timeFrame': 'Pre-surgery', 'description': 'Surface EMG assessment of the hamstrings'}, {'measure': 'Surface EMG', 'timeFrame': '14 days post op', 'description': 'Surface EMG assessment of the hamstrings'}, {'measure': 'Surface EMG', 'timeFrame': '2 months post op', 'description': 'Surface EMG assessment of the hamstrings'}, {'measure': 'Surface EMG', 'timeFrame': '4 months post op', 'description': 'Surface EMG assessment of the hamstrings'}, {'measure': 'Surface EMG', 'timeFrame': '6 months post op', 'description': 'Surface EMG assessment of the hamstrings'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee pathology'], 'conditions': ['Anterior Cruciate Ligament Injuries']}, 'descriptionModule': {'briefSummary': 'Anterior cruciate ligament (ACL) injuries account for up to 25% of knee injuries, it is estimated that 32,000-400,000 new cases of ACL tears occur in the USA every year.\n\nThe Standard care is twofold; a) ACL reconstruction surgery and b) prolonged rehabilitation period (usually no less than 9 months). However, a large amount of patients do not return to their pre-injury activity level, and up to 30% reinjure their ACL in the following two years.\n\nThe wearable system consists of two non-invasive bands, above and below the knee that vibrate during the weight bearing phase while walking.', 'detailedDescription': 'The objective of this study is to investigate the effect of treatment for ACL reconstruction, including vibrational stimulation and pressure, on locomotion tasks (i.e. walking, stair ascending and descending), muscle function, and pain/function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Males and females\n* Aged 18-50\n* Scheduled for an ACL reconstruction in Rambam hospital.\n* Hebrew language at mother tongue level\n\nExclusion Criteria:\n\n* Inability to understand the study protocol.\n* Known neuropathies, active cancer, previous fractures in the lower limbs, inflammatory arthritis, implanted electronic devices of any kind.\n* Allergies to silver or adhesives.'}, 'identificationModule': {'nctId': 'NCT05001594', 'briefTitle': 'Wearable Vibration Effect on Biomechanics and Biomarkers After ACL Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Technion, Israel Institute of Technology'}, 'officialTitle': 'The Effects of a Wearable Vibratory Device on Biomechanics, Quality of Life and Serum Biomarkers After an ACL Reconstruction Surgery', 'orgStudyIdInfo': {'id': '0089-21-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care+ Sham device', 'description': 'Each participant will go through the normal rehabilitation process that follows ACL reconstruction+ a sham device used in the same was as the intervention group.\n\nThe sham device will look the same, will gave the same pressure around the leg, but will not vibrate.'}, {'type': 'EXPERIMENTAL', 'label': 'Usual care+ knee vibratory device', 'description': 'Each participant will go through the normal rehabilitation process that follows ACL reconstruction. Additionally, each participant will receive the active device that applies non-invasive vibrational stimulation to the leg for two months, and will be asked to wear it during ambulation for at least an hour per day.', 'interventionNames': ['Device: Active vibratory knee device']}, {'type': 'NO_INTERVENTION', 'label': 'Normative data', 'description': 'Healthy participants will go through one session of the full protocol (excluding blood tests):\n\n* Questionnaires (IKDC, TSK, GAD-7).\n* Biomechanical analysis during walking, stair ambulation, and hoping.\n* Quadriceps and Hamstring strength testing'}], 'interventions': [{'name': 'Active vibratory knee device', 'type': 'DEVICE', 'description': 'The active, wearable device is placed above and below the knee joint. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide vibratory feedback to the subject.', 'armGroupLabels': ['Usual care+ knee vibratory device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3109601', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Arielle Fischer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technion, Israel Institute of Technology'}, {'name': 'Bezalel Peskin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technion, Israel Institute of Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rambam Health Care Campus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Arielle Fischer', 'investigatorAffiliation': 'Technion, Israel Institute of Technology'}}}}