Dynamic Quadriceps Muscle Stimulation for Treatment of Patellofemoral Pain

NCT02243332 | Completed

• 1 other identifier: ALI-KS-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patellofemoral Pain Syndrome; Anterior Knee Pain Syndrome

Keywords

Knee; Pain; Joint; Rehabilitation; Patellofemoral Pain Syndrome; Anterior Knee Pain Syndrome; Knee Pain; Quadriceps

Outcome Measures

Primary Outcomes (1)

• Measured Quadriceps Musculature Co-Contraction

  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.

  20, 40, 60, 80 minutes from start of single-day testing

Secondary Outcomes (2)

• Anterior Knee Pain

  20, 40, 60, 80 minutes from start of single-day testing

• Device Joint Model Accuracy

  20, 40, 60, 80 minutes from start of single-day testing

Study Arms (1)

Device (rehabilitation assistance)

EXPERIMENTAL

Device: KneeStim mobile rehabilitation assistance device

Device: KneeStim mobile rehabilitation assistance device

Interventions

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.

Also known as: KneeStim

Device (rehabilitation assistance)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-40 years
• Symptomatic PFPS on Patella Glide Test, Patella Tilt Test, and Patellar Apprehension Test.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Articulate Labs: lead
• University of Texas at Austin: collaborator

Study Sites (1)

Developmental Motor Control Lab; University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome; Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa Griffin, Ph.D.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2014
• First Posted: September 17, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 27, 2017

Record last verified: 2017-06

Locations

US (1)