This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Dynamic Quadriceps Muscle Stimulation for Treatment of Patellofemoral Pain

This study has been completed.
Sponsor:
Collaborator:
University of Texas at Austin
Information provided by (Responsible Party):
Articulate Labs
ClinicalTrials.gov Identifier:
NCT02243332
First received: September 12, 2014
Last updated: June 26, 2017
Last verified: June 2017
September 12, 2014
June 26, 2017
September 2014
March 2017   (Final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT02243332 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Dynamic Quadriceps Muscle Stimulation for Treatment of Patellofemoral Pain
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Patellofemoral Pain Syndrome
  • Anterior Knee Pain Syndrome
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
Experimental: Device (rehabilitation assistance)
Device: KneeStim mobile rehabilitation assistance device
Intervention: Device: KneeStim mobile rehabilitation assistance device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2017
March 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 40 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02243332
ALI-KS-001
No
Not Provided
Not Provided
Articulate Labs
Articulate Labs
University of Texas at Austin
Principal Investigator: Lisa Griffin, Ph.D. University of Texas at Austin
Articulate Labs
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP