Patellofemoral Pain SyndromeNCT02243332
Dynamic Quadriceps Muscle Stimulation for Treatment of Patellofemoral Pain
A study testing KneeStim mobile rehabilitation assistance device in people with Patellofemoral Pain Syndrome and Anterior Knee Pain Syndrome, run by Articulate Labs at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome
- What is being tested?
- KneeStim mobile rehabilitation assistance device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-40 years
- Symptomatic PFPS on Patella Glide Test, Patella Tilt Test, and Patellar Apprehension Test.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Developmental Motor Control Lab; University of Texas at Austin
Austin, Texas, 78712
About this study
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.
Read the 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.
- Being tested
- KneeStim mobile rehabilitation assistance device
- Keywords
- Knee, Pain, Joint, Rehabilitation, Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome, Knee Pain, Quadriceps
- Medical subject headings
- Patellofemoral Pain Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KneeStim mobile rehabilitation assistance deviceDevice
Also called KneeStim
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.
| Study group | Role | What they receive |
|---|---|---|
| Device (rehabilitation assistance) | Experimental | Device: KneeStim mobile rehabilitation assistance device Receives: Device: KneeStim mobile rehabilitation assistance device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20, 40, 60, 80 minutes from start of single-day testing
Secondary outcomes (2)
Anterior Knee Pain
Measured with Anterior Knee Pain Scale (AKPS) after each Six Minute Walk Test.
Measured: 20, 40, 60, 80 minutes from start of single-day testing
Device Joint Model Accuracy
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.
Measured: 20, 40, 60, 80 minutes from start of single-day testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Articulate Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Texas at Austin
- Responsible party
- Sponsor
- Investigators
- Lisa Griffin, Ph.D., Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243332
- Sponsor's protocol ID
- ALI-KS-001
- Status last verified
- Jun 2017
- First submitted
- 12 Sep 2014
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Quadriceps Muscle Stimulation for Treatment of Patellofemoral Pain
- ClinicalTrials.gov ID
- NCT02243332
- Acronym / sponsor ID
- ALI-KS-001
- Keywords
- Knee, Pain, Joint, Rehabilitation, Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome, Knee Pain, Quadriceps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Articulate LabsIndustry (pharma, biotech, devices)
- Collaborators
- University of Texas at Austin
- Study start
- Sep 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 17 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device (rehabilitation assistance) | Experimental | Device: KneeStim mobile rehabilitation assistance deviceDevice: KneeStim mobile rehabilitation assistance device |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 18-40 years
- Symptomatic PFPS on Patella Glide Test, Patella Tilt Test, and Patellar Apprehension Test.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KneeStim mobile rehabilitation assistance deviceAlso: KneeStimKneeStim 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. | Device | Device (rehabilitation assistance) |
Primary outcome
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.
2 secondary outcomes
Anterior Knee Pain
Time frame: 20, 40, 60, 80 minutes from start of single-day testing
Device Joint Model Accuracy
Time frame: 20, 40, 60, 80 minutes from start of single-day testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- For more information about the Developmental Motor Control Lab where this pilot study will be heldLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Griffin, Ph.D. principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KneeStim mobile rehabilitation assistance device in people with Patellofemoral Pain Syndrome and Anterior Knee Pain Syndrome, run by Articulate Labs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measured Quadriceps Musculature Co-Contraction (time frame: 20, 40, 60, 80 minutes from start of single-day testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.