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

Reliability and Validity of Self-reported Adherence to Elbow Orthosis Wearing Time Using Concealed Temperature Sensors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Elbow Fracture; Elbow Injury; Elbow Arthritis
• Intervention / Treatment: Device: Custom fabricated elbow extension orthosis

Detailed Description

The elbow is prone to stiffness following trauma. Orthoses or splints are commonly used to manage this stiffness and prevent flexion contractures following elbow injury. One of the main orthoses used to treat patients who cannot extend their elbow following injury is to make an orthosis or splint to hold the elbow as straight as possible through the night to provide a gentle stretch. As patients gain the ability to straighten their elbow, the orthosis is reshaped over several weeks to continue to provide a stretch at night. This study will investigate the effectiveness of these orthoses for improving ROM, by correlating actual wearing time to ROM measurements. To date, there is no objective way of measuring whether patients actually wear these orthoses at night. Measurement of actual wearing time in the splint has been dependent on self-reported diaries to document wearing time.

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 a secondary outcome, we will look at whether the slightly different way the orthosis is made changes elbow stiffness via range of motion measurements of the elbow. Other data collected will include patient reported outcome measures including the Patient Rated Elbow Evaluation, The Disabilities of Arm, Shoulder, and Hand Questionnaire, and a patient satisfaction survey. 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 wearing time to changes in range of motion.

The Sensors are able to record 2 weeks on continuous data, and patients will be followed for 3 total visits - one for splint fabrication, at 2 weeks, 4 weeks, and 6 weeks, post splint fabrication. Patients will also attend regular therapy visits as needed, independent of these followups.

• Study Type: Observational
• Enrollment (Anticipated): 55

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elbow ROM	goniometric measurement	6 months
Patient Rated Elbow Evaluation	patient reported outcome measure	6 months

Collaborators and Investigators

• Sponsor: Western University, Canada
• Collaborators: Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: 12567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No