Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05437133 |
| Other study ID # |
12567 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2022 |
| Est. completion date |
January 1, 2025 |
Study information
| Verified date |
June 2022 |
| Source |
Western University, Canada |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
