Patellofemoral Pain Syndrome Clinical Trial
Official title:
Dynamic Quadriceps Muscle Stimulation for Treatment of Patellofemoral Pain
Verified date | June 2017 |
Source | Articulate Labs |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Aged 18-40 years - Symptomatic PFPS on Patella Glide Test, Patella Tilt Test, and Patellar Apprehension Test. Exclusion Criteria: - Rheumatoid arthritis or inflammatory arthritis as assessed by licensed physician - Use of walking aids other than a cane more than 50% of the time in ambulation - Diagnosed knee disorder other than patellofemoral syndrome - Pacemaker use, unstable angina, or decompensated heart failure - Knee replaced in preceding 12 months or replacement planned within 6 months - Moderate to severe dementia - Pregnancy (self report) - Altered sensation at the knee such that the patient is unable to perceive the presence of pinprick. - Use of intra-articular viscosupplementation or steroid injection within preceding 2 months. - Use of chronic anticoagulation medication. - Movement-limiting pain in the back, hip, ankle, or foot of either lower limb. |
Country | Name | City | State |
---|---|---|---|
United States | Developmental Motor Control Lab; University of Texas at Austin | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
Articulate Labs | University of Texas at Austin |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measured Quadriceps Musculature Co-Contraction | 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. 6MWT #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 The time period in which a partipant will be involved is not expected to exceed 90 minutes. |
20, 40, 60, 80 minutes from start of single-day testing | |
Secondary | Anterior Knee Pain | Measured with Anterior Knee Pain Scale (AKPS) after each Six Minute Walk Test. | 20, 40, 60, 80 minutes from start of single-day testing | |
Secondary | Device Joint Model Accuracy | 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. | 20, 40, 60, 80 minutes from start of single-day testing |
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