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
Name Time Method Patient Activity Measure (PAM-13) Questionnaire Follow Up Visits up to 1-Year A subjective evaluation of perceived compliance with physician instructions
- Secondary Outcome Measures
Name Time Method 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