Study Results
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View full resultsBasic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2018-01-15
2019-01-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Experimental Treatment A then B
Subjects will receive two treatments: (1) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback (vibration) to the subject and (2) a commercially-available knee sleeve, separated by a washout period.
Cutaneous Stimulation
A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.
Knee Sleeve
Commercially-available knee sleeve.
Experimental Treatment B then A
Subjects will receive two treatments: (1) a commercially-available knee sleeve and (2) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback (vibration) to the subject, separated by a washout period.
Cutaneous Stimulation
A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.
Knee Sleeve
Commercially-available knee sleeve.
Interventions
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Cutaneous Stimulation
A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.
Knee Sleeve
Commercially-available knee sleeve.
Eligibility Criteria
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Inclusion Criteria
* Ambulatory
* Symptomatic knee pain ≥ 3/10 on most of the past 30 days
* Prior ACL injury/surgery, meniscus injury/surgery, and/or physician-diagnosed medial compartment knee osteoarthritis (KL grade 1-3)
* Agreement and ability to use provided interventions during the study period (suggested cumulative wear time during walking of 1-2 hr/day)
* Committed to not starting any new therapies for knee condition during the trial, other than rescue pain medication.
Exclusion Criteria
* BMI ≥ 35 kg/m2
* Injection in the affected knee during the previous three months
* Known neuropathy due to diabetes or other causes
* Inability to provide informed consent
18 Years
80 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Thomas Peter Andriacchi
Principal Investigator
Principal Investigators
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Thomas Andriacchi, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University
Stanford, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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40688
Identifier Type: -
Identifier Source: org_study_id
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