Joint Instability
Conditions
Keywords
Pain, Ankle, Knee, Brace
Brief summary
This study will look to examine the overall performance of a custom fit knee or ankle brace as a means of providing ankle or knee joint support in subjects that have determined the need for bracing based upon chronic joint instability and/or joint swelling and pain following daily activity.
Interventions
DEVICEDr. Scholl's Prototype Ankle Brace
Subjects will be instructed to wear the assigned Ankle/Knee brace for 8 ± 2 hours per day, for a minimun of 5 days out of a 7-day/1 week wear period.
DEVICEDr. Scholl's Prototype Knee Brace
Subjects will be instructed to wear the assigned Ankle/Knee brace for 8 ± 2 hours per day, for a minimun of 5 days out of a 7-day/1 week wear period.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort | Up to 15 days | Comfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale. |
| Pain Relief of Knee or Ankle joint | Up to 15 days | Evaluation of Knee or Ankle joint pain will be performed using the Visual Analog Scale utilizing a 100 mm line defined at each end of the line by 0 = no pain and 100 = Worst pain possible. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Product Fit | Up to 15 days | Product Fit is assessed utilizing a 7-point scale. |
| Product Support | Up to 15 days | Support is assessed utilizing a 5-point scale. |
| Freedom of Movement | Up to 15 days | Freedom of Movement is assessed utilizing a 6-point scale. |
| Subjective Questions | Up to 15 days | Applicable subjective questions will be assessed utilizing the subjective questionnaire. |
Countries
United States
Outcome results
None listed