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

University of Utah1 site in 1 country38 target enrollmentAugust 2014

ConditionsAnkle Fracture

Overview

Phase: N/A
Intervention: Not specified
Conditions: Ankle Fracture
Sponsor: University of Utah
Enrollment: 38
Locations: 1
Primary Endpoint: Patient Activity Measure (PAM-13) Questionnaire
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

July 13, 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Utah

Responsible Party

Principal Investigator

David Rothberg

M.D.

University of Utah

Eligibility Criteria

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)

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