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

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.

Completed

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Key information

Conditions

Ankle Fracture Ankle Fractures Ankle Injuries Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah Orthopedics Center

Salt Lake City, Utah, 84121, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Patient Activity Measure (PAM-13) Questionnaire

Time frame: Follow Up Visits up to 1-Year

A subjective evaluation of perceived compliance with physician instructions

Secondary outcomes

X-ray (AP and Lateral)

Time frame: Follow Up Visits up to 1-Year

Subjectively evaluate fracture healing

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Jan 8, 2015
Registry last updated: Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed