Dynamic Quadriceps Muscle Stimulation for Treatment of Patellofemoral Pain
Condition: Patellofemoral Pain Syndrome; Anterior Knee Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): KneeStim mobile rehabilitation assistance device
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): KneeStim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Knee; Pain; Joint; Rehabilitation; Patellofemoral Pain Syndrome; Anterior Knee Pain Syndrome; Knee Pain; Quadriceps