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Dynamic Quadriceps Muscle Stimulation for Treatment of Patellofemoral Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02243332
First Posted: September 17, 2014
Last Update Posted: June 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Texas at Austin
Information provided by (Responsible Party):
Articulate Labs
  Purpose
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.

Condition Intervention
Patellofemoral Pain Syndrome Anterior Knee Pain Syndrome Device: KneeStim mobile rehabilitation assistance device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dynamic Quadriceps Muscle Stimulation for Treatment of Patellofemoral Pain

Resource links provided by NLM:


Further study details as provided by Articulate Labs:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.


Enrollment: 20
Actual Study Start Date: September 2014
Study Completion Date: March 2017
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device (rehabilitation assistance)
Device: KneeStim mobile rehabilitation assistance device
Device: KneeStim mobile rehabilitation assistance 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 Name: KneeStim

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02243332


Locations
United States, Texas
Developmental Motor Control Lab; University of Texas at Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
Articulate Labs
University of Texas at Austin
Investigators
Principal Investigator: Lisa Griffin, Ph.D. University of Texas at Austin
  More Information

Additional Information:
Responsible Party: Articulate Labs
ClinicalTrials.gov Identifier: NCT02243332     History of Changes
Other Study ID Numbers: ALI-KS-001
First Submitted: September 12, 2014
First Posted: September 17, 2014
Last Update Posted: June 27, 2017
Last Verified: June 2017

Keywords provided by Articulate Labs:
Knee
Pain
Joint
Rehabilitation
Patellofemoral Pain Syndrome
Anterior Knee Pain Syndrome
Knee Pain
Quadriceps

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Patellofemoral Pain Syndrome
Disease
Pathologic Processes
Mental Disorders
Joint Diseases
Musculoskeletal Diseases