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

NCT02334618 | Completed

• 1 other identifier: 73982
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Fracture

Outcome Measures

Primary Outcomes (1)

• Patient Activity Measure (PAM-13) Questionnaire

  A subjective evaluation of perceived compliance with physician instructions

  Follow Up Visits up to 1-Year

Secondary Outcomes (1)

• X-ray (AP and Lateral)

  Follow Up Visits up to 1-Year

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who present to the University of Utah emergency department with ankle fractures.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopedics Center

Salt Lake City, Utah, 84121, United States

Location

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• David Rothberg, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 8, 2015
• Study Start: August 1, 2014
• Primary Completion: July 13, 2017
• Study Completion: July 13, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-08

Locations

US (1)