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Insole Sensor to Determine Optimal Limb Loading in the Rehabilitation of Ankle Fractures

Completed
Conditions
Ankle Fracture
Registration Number
NCT02334618
Lead Sponsor
University of Utah
Brief Summary

The purpose of this study is to use a novel load monitoring technology to correlate limb loading to ankle fracture outcomes. This study will collect continuous limb loading data and will provide the first objective insight into how limb loading directs fracture healing.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
38
Inclusion Criteria
  • Patient is 18 years of age or older
  • Patient has an ankle fracture
  • Patient speaks English
  • Patient weighs between 100 and 250 pounds
  • Patient lives in close enough proximity to the hospital to return for all appointments (~100 miles)
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Exclusion Criteria
  • Patient is younger than 18 years of age
  • Patient has multiple fractures that would alter weight bearing protocol
  • Patient does not speak English
  • Patient weighs less than 100 pounds or more than 250 pounds
  • Patient does not live in close enough proximity to the hospital to return for all appointments (~>100 miles)
  • Patient has a traumatic brain injury that would make it so they cannot consent
  • Patient has diabetes
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Patient Activity Measure (PAM-13) QuestionnaireFollow Up Visits up to 1-Year

A subjective evaluation of perceived compliance with physician instructions

Secondary Outcome Measures
NameTimeMethod
X-ray (AP and Lateral)Follow Up Visits up to 1-Year

Subjectively evaluate fracture healing

Trial Locations

Locations (1)

University of Utah Orthopedics Center

🇺🇸

Salt Lake City, Utah, United States

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