Effectiveness of BREG Flex in 12-week Peri-operative Total Knee Arthroplasty

Inclusion Criteria:

1. Individuals who are scheduled for Total Knee Arthroplasty by a single surgeon
(Burnikel)

2. Individuals who are at least 55 years of age

3. Individuals with a body mass index (BMI) <45

4. Must be able and willing to complete all study assessments and to be followed for the
full course of the study.

5. Must be able to read, write and follow instructions in English.

6. Must be able and willing to provide informed consent.

7. Must be willing and able to attend the pre-op assessment

Exclusion Criteria:

1. Individuals with a history of any underlying neurological conditions

2. Individuals with a history of stroke

3. Individuals with a history of neurological disorder that affects lower extremity
function (stroke, peripheral neuropathy, Parkinson's disease, multiple sclerosis,
etc.)

4. Individuals with physical conditions which would make them unable to perform study
procedures

5. Pregnant women or inadequate precautions to prevent pregnancy

6. Diagnosis of a medical condition that would contraindicate treatment with the product,
e.g. skin lesions at electrode site.

7. Individuals with a diagnosis of inflammatory arthritis (Rheumatoid arthritis, gout or
psoriatic arthritis)?

8. Individuals with muscle diseases (i.e. muscular dystrophy)

9. Visible skin injury or disease on their legs

10. Principal investigator for this study, or member of study staff