Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-01-01 @ 12:20 PM
Study NCT ID:
NCT02243332
Status:
COMPLETED
Last Update Posted:
2017-06-27
First Post:
2014-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Quadriceps Muscle Stimulation for Treatment of Patellofemoral Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046788', 'term': 'Patellofemoral Pain Syndrome'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-26', 'studyFirstSubmitDate': '2014-09-12', 'studyFirstSubmitQcDate': '2014-09-15', 'lastUpdatePostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measured Quadriceps Musculature Co-Contraction', 'timeFrame': '20, 40, 60, 80 minutes from start of single-day testing', 'description': 'Electromyographic (EMG) readings of vastus lateralis and vastus medialis contraction patterns will be taken after four six-minute walk tests (6MWTs) to evaluate any short-term changes in co-contraction.\n\n6MWT #1: Without interventional device being worn; 6MWT #2: With interventional device being worn, but unpowered; 6MWT #3: With interventional device being worn and operational; 6MWT #4: Without interventional device being worn\n\nThe time period in which a partipant will be involved is not expected to exceed 90 minutes.'}], 'secondaryOutcomes': [{'measure': 'Anterior Knee Pain', 'timeFrame': '20, 40, 60, 80 minutes from start of single-day testing', 'description': 'Measured with Anterior Knee Pain Scale (AKPS) after each Six Minute Walk Test.'}, {'measure': 'Device Joint Model Accuracy', 'timeFrame': '20, 40, 60, 80 minutes from start of single-day testing', 'description': "The interventional device uses an on-board operating system that determines stimulation timing and location based on modeled joint kinematics. Movement data will be taken from the device and evaluated against movement data measured by a VICON motion-tracking system during each six-minute walk test to evaluate the accuracy of the device's modeled joint kinematics."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Knee', 'Pain', 'Joint', 'Rehabilitation', 'Patellofemoral Pain Syndrome', 'Anterior Knee Pain Syndrome', 'Knee Pain', 'Quadriceps'], 'conditions': ['Patellofemoral Pain Syndrome', 'Anterior Knee Pain Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this small, pilot study is to evaluate a novel device that uses neuromuscular electrical stimulation to assist quadriceps muscles as a user walks. This study will involve use of this device on individuals with patellofemoral pain, a relatively common injury among active people, to see if quadriceps stimulation could mitigate disparities in quadriceps activation timing that may indirectly lead to knee pain.', 'detailedDescription': "The interventional device will be tested with 20 women aged 18-40 with evidence of patellofemoral pain syndrome (PFPS) and without any co-morbidities that would confound data or contraindications for NMES use. All participants will be enrolled at a single site (Developmental Motor Lab at the University of Texas), and all of a single participant's testing will be complete within a single day with no requirement for follow-up or long-term participation. Participants will have their gait and quadriceps muscle activation patterns evaluated through four six-minute walk tests (6MWT). The first 6MWT will be without a device, second with a device worn but not activated, third with a device activated and stimulating quadriceps musculature, and the fourth without a device.\n\nPrimary Objective: The purpose of this study is to investigate whether electrical stimulation of the vastus medalis (VM) and/or vastus lateralis (VL) to establish coactivation of these muscles during terminal swing phase impacts severity of PFPS symptoms\n\nSecondary Objectives: Secondary purposes for this study include evaluating KneeStim and seeing if there is any evidence of proof of concept in two main areas:\n\nKneeStim as a therapeutic device that may assist individuals with joint rehabilitation KneeStim's on-board operating system and motion tracking system as an effective way to monitor joint kinematics.\n\nThis pilot study has a prospective, controlled, single-center design. Participants and investigators will not be blinded to the treatment. Individuals who evaluate the motion-tracking data between VICON and KneeStim will not be informed which data set aligns with which treatment."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-40 years\n* Symptomatic PFPS on Patella Glide Test, Patella Tilt Test, and Patellar Apprehension Test.\n\nExclusion Criteria:\n\n* Rheumatoid arthritis or inflammatory arthritis as assessed by licensed physician\n* Use of walking aids other than a cane more than 50% of the time in ambulation\n* Diagnosed knee disorder other than patellofemoral syndrome\n* Pacemaker use, unstable angina, or decompensated heart failure\n* Knee replaced in preceding 12 months or replacement planned within 6 months\n* Moderate to severe dementia\n* Pregnancy (self report)\n* Altered sensation at the knee such that the patient is unable to perceive the presence of pinprick.\n* Use of intra-articular viscosupplementation or steroid injection within preceding 2 months.\n* Use of chronic anticoagulation medication.\n* Movement-limiting pain in the back, hip, ankle, or foot of either lower limb.'}, 'identificationModule': {'nctId': 'NCT02243332', 'briefTitle': 'Dynamic Quadriceps Muscle Stimulation for Treatment of Patellofemoral Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Articulate Labs'}, 'officialTitle': 'Dynamic Quadriceps Muscle Stimulation for Treatment of Patellofemoral Pain', 'orgStudyIdInfo': {'id': 'ALI-KS-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device (rehabilitation assistance)', 'description': 'Device: KneeStim mobile rehabilitation assistance device', 'interventionNames': ['Device: KneeStim mobile rehabilitation assistance device']}], 'interventions': [{'name': 'KneeStim mobile rehabilitation assistance device', 'type': 'DEVICE', 'otherNames': ['KneeStim'], 'description': "KneeStim is a neuromuscular electrical stimulation (NMES) device that integrates motion-tracking hardware like three-axis accelerometers and a real-time operating system to enable quadriceps muscle stimulation in time with user gait. It is a completely non-invasive device that looks like a light brace and fastens to the user's quadriceps and gastrocnemius muscles. The end goal of this device is to assist with muscle re-strengthening and re-education during a user's everyday activities.", 'armGroupLabels': ['Device (rehabilitation assistance)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78712', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Developmental Motor Control Lab; University of Texas at Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Lisa Griffin, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas at Austin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Articulate Labs', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Texas at Austin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}