Developmental Motor Control Lab; University of Texas at Austin
Austin, Texas, 78712, United States
NCT Number: NCT02243332
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.
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Notify Me18 year–40 year
Female
Interventional
Not applicable
Austin, Texas, 78712, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: KneeStim
Time frame: 20, 40, 60, 80 minutes from start of single-day testing
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.
Time frame: 20, 40, 60, 80 minutes from start of single-day testing
Measured with Anterior Knee Pain Scale (AKPS) after each Six Minute Walk Test.
Time frame: 20, 40, 60, 80 minutes from start of single-day testing
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.
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