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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
183
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.
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.
Unnamed facility
Colorado Springs, Colorado, United States
Unnamed facility
Richardson, Texas, United States
Comfort
Comfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale.
Time frame: 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.
Time frame: Up to 15 days
Product Fit
Product Fit is assessed utilizing a 7-point scale.
Time frame: Up to 15 days
Product Support
Support is assessed utilizing a 5-point scale.
Time frame: Up to 15 days
Freedom of Movement
Freedom of Movement is assessed utilizing a 6-point scale.
Time frame: Up to 15 days
Subjective Questions
Applicable subjective questions will be assessed utilizing the subjective questionnaire.
Time frame: Up to 15 days
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