Clinical Trial: 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 Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome:

• Comfort [ Time Frame: Up to 15 days ]
  Comfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale.
• Pain Relief of Knee or Ankle joint [ Time Frame: 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome: Same as current

Information By: Bayer

Dates:
Date Received: February 11, 2016
Date Started: February 2016
Date Completion:
Last Updated: May 3, 2016
Last Verified: May 2016