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Reliability and Validity of Self-reported Adherence to Elbow Orthosis Wearing Time

NCT05437133 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2022-06-29

No results posted yet for this study

Summary

The purpose of this study is to validate whether the use of a self-reported diary for orthosis use is accurate and valid. We will insert a temperature gauge into the orthosis during fabrication that measures temperature to an accuracy of one degree Celcius. This sensor is about the size of a watch battery, and patients will be told that it is measuring the force of stretch applied to the elbow, while in fact, it is measuring the amount of time that the orthosis is being worn. The temperature of the skin while wearing the orthosis heats up the sensor, and we can accurately predict (within 5 minutes of accuracy) how long the orthosis is worn each day.

We will have patients also fill out a self-report diary outlining how long they are wearing the orthosis each day, and compare these times to the measurements taken by the sensor. As secondary outcomes, we will look at whether the orthoses improve elbow range of motion (ROM), patient satisfaction, and improvement over time on patient reported outcome measures. This study will provide important information about the validity and reliability of using diaries to measure adherence to orthoses, and will be the first to provide objective data regarding the actual use of these orthoses and whether they help to decrease elbow stiffness.

Conditions

  • Elbow Injury
  • Elbow Fracture
  • Elbow Arthritis

Interventions

DEVICE

Custom fabricated elbow extension orthosis

custom low temperature thermoplastic orthosis (Splint) holding the elbow in maximum extension at night

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    collaborator OTHER

  • Western University, Canada

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2024-07-01
Completion
2025-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05437133 on ClinicalTrials.gov