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Completed

NCT Number: NCT02243332

Dynamic Quadriceps Muscle Stimulation for Treatment of Patellofemoral Pain

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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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Developmental Motor Control Lab; University of Texas at Austin

Austin, Texas, 78712, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KneeStim mobile rehabilitation assistance device

Device

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

Primary outcomes

  1. Measured Quadriceps Musculature Co-Contraction

    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.

Secondary outcomes

  1. Anterior Knee Pain

    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.

  2. Device Joint Model Accuracy

    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.

Sponsors and collaborators

Lead sponsor

Articulate Labs

Industry

Collaborators

  • University of Texas at Austin

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 17, 2014
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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