Dynamic Quadriceps Muscle Stimulation for Treatment of Patellofemoral Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Primary 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 Secondary Objectives: Secondary purposes for this study include evaluating KneeStim and seeing if there is any evidence of proof of concept in two main areas: KneeStim 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. This 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.

Official Title
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Dynamic Quadriceps Muscle Stimulation for Treatment of Patellofemoral Pain

Conditions
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Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome

Intervention / Treatment
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* Device: KneeStim mobile rehabilitation assistance device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device (rehabilitation assistance)<br>Device: KneeStim mobile rehabilitation assistance device | Device: KneeStim mobile rehabilitation assistance device<br>* 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.<br>* Other names: KneeStim;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee, Pain, Joint, Rehabilitation, Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome, Knee Pain, Quadriceps