check_circleStudy Completed

Joint instability

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

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years

Trial summary

Enrollment Goal
183
Trial Dates
February 2016 - April 2016
Phase
N/A
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Richardson, 75081, United States
Completed
Colorado Springs, 80915, United States

Primary Outcome

  • Comfort
    Comfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale.
    date_rangeTime Frame:
    Up to 15 days
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    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Up to 15 days
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    Safety Issue:
    No

Secondary Outcome

  • Product Fit
    Product Fit is assessed utilizing a 7-point scale.
    date_rangeTime Frame:
    Up to 15 days
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    Safety Issue:
    No
  • Product Support
    Support is assessed utilizing a 5-point scale.
    date_rangeTime Frame:
    Up to 15 days
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    Safety Issue:
    No
  • Freedom of Movement
    Freedom of Movement is assessed utilizing a 6-point scale.
    date_rangeTime Frame:
    Up to 15 days
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    Safety Issue:
    No
  • Subjective Questions
    Applicable subjective questions will be assessed utilizing the subjective questionnaire.
    date_rangeTime Frame:
    Up to 15 days
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Device
Trial Purpose
Supportive Care
Allocation
N/A
Blinding
Single Blind
Assignment
Single Group Assignment
Trial Arms
1