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

NCT05437133 | Unknown

• 1 other identifier: 12567
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Orthosis wearing time (sensor measured)

  overall time in orthosis as measured by the sensor

  6 weeks

• Orthosis wearing time (self-reported)

  overall time in orthosis reported by the patient

  6 weeks

Secondary Outcomes (2)

• Elbow ROM

  6 months

• Patient Rated Elbow Evaluation

  6 months

Interventions

Custom fabricated elbow extension orthosis DEVICE

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

Eligibility Criteria

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

Study Population

All patients over age 18, with elbow trauma, referred by the Upper Limb Surgeons at the Roth McFarlane Hand \& Upper Limb Centre for night time extension splinting of the elbow following trauma. We will enroll patients consecutively.

You may qualify if:

• All patients over age 18, with elbow trauma, referred by the Upper Limb Surgeons at the Roth McFarlane Hand \& Upper Limb Centre (HULC) for night time extension splinting of the elbow following trauma

You may not qualify if:

• Elbow instability, infection, or other condition precluding the use of an extension orthosis at night time. Inability to wear the orthosis due to know skin reactions, claustrophobia, or ability to understand instructions and precautions provided in English. Patients will also be excluded if they are unable to return to HULC for follow up due to driving distance.

Sponsors & Collaborators

• Western University, Canada: lead
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator

MeSH Terms

Conditions

Elbow Injuries; Elbow Fractures

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: January 1, 2025
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share