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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Joint Instability

Intervention / Treatment
-----------------
* Device: Dr. Scholl's Prototype Ankle Brace
* Device: Dr. Scholl's Prototype Knee Brace


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ankle/Knee brace<br>Dr. Scholl's Prototype Ankle or Knee Brace | Device: Dr. Scholl's Prototype Ankle Brace<br>* 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.<br>Device: Dr. Scholl's Prototype Knee Brace<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort | Comfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale. | Up to 15 days | 
| Pain Relief of Knee or Ankle joint | 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. | Up to 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Product Fit | Product Fit is assessed utilizing a 7-point scale. | Up to 15 days | 
| Product Support | Support is assessed utilizing a 5-point scale. | Up to 15 days | 
| Freedom of Movement | Freedom of Movement is assessed utilizing a 6-point scale. | Up to 15 days | 
| Subjective Questions | Applicable subjective questions will be assessed utilizing the subjective questionnaire. | Up to 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Ankle, Knee, Brace