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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02334618
Enrollment
38
Registered
2015-01-08
Start date
2014-08-31
Completion date
2017-07-13
Last updated
2017-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Fracture

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.

Interventions

None listed

Sponsors

University of Utah
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient Activity Measure (PAM-13) QuestionnaireFollow Up Visits up to 1-YearA subjective evaluation of perceived compliance with physician instructions

Secondary

MeasureTime frameDescription
X-ray (AP and Lateral)Follow Up Visits up to 1-YearSubjectively evaluate fracture healing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026