A Multi-Site Evaluation of the Pain Relief, Support, Fit and Comfort From Use of a Custom Knee or Ankle Brace in Persons Suffering From Chronic Ankle or Knee Pain and Instability

Inclusion Criteria:

- Subjects must indicate that they currently have weakened ankles or knees and that they
experience chronic discomfort after performing daily activities.

- Subjects must suffer from pain assessed on a 100 mm (10 cm) Visual Analog Scale (VAS)
of ≥20 mm to ≤ 90 mm for subjects with either unstable ankle or unstable knee, at
Visit 1 and 2.

- Subjects must be able to walk unaided by cane or walker.

- Subjects must not have a noticeable limp or other permanent ailment that interferes
with normal gait.

- Subjects free of other types of health problems that, in the opinion of the
Investigator, could influence their ability to participate.

- If subjects are taking pain medication (prescription or Over-the-counter (OTC)) for a
chronic condition, they may continue that medication as long as they have been on a
stable dose for at least 2 months, and agree to continue their regular dose and
regimen for the duration of the study.

- Subjects must be willing to undergo a 1-week period without a brace and then willing
to wear a brace for a 1-week period, that is: 8 ±2 hours a day for a minimum of 5 out
of 7 days.

Exclusion Criteria:

- Subjects with an ankle or knee pain and instability which is due to a recent sprains,
strains, or other non-reversible injury to the knee or ankle.

- Subjects who have diabetes, circulatory problems, open wounds, and lack of sensation
in the ankles, knees, or feet or any problems that would make brace wear uncomfortable
or inappropriate.

- Subjects who wear a physician-prescribed orthotic device, prescription shoes or back
braces.

- Subjects who are undergoing traction or manipulative back adjustments or have had a
traumatic injury to the lower extremity (deemed of non-overuse nature), which in the
opinion of the examining Investigator would interfere with the study evaluations.

- Subjects whose condition requires surgery or other medical intervention or who have
undergone foot back or knee surgery within the past 3 months or with any planned
surgeries and/or invasive medical procedures during the course of the study.

- Subjects who are currently taking an opioid based pain medication or have taken such
medication within 2 months prior to Visit 1.

- Subjects who are taking any chronic pain medication (prescription or OTC) for at least
2 months, who do not agree to continue taking it at the same dose and regimen
throughout the study.

- Subjects who have severely painful bunions, warts, corns and/or calluses, severely
overlapping toes or lesions on the bottom of their foot.

- Subjects who have sensitivities or allergies to plastics or adhesives.