Elbow InjuryNCT05437133
Reliability and Validity of Self-reported Adherence to Elbow Orthosis Wearing Time
An observational study of Elbow Injury and Elbow Fracture, run by Western University, Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elbow Injury, Elbow Fracture, Elbow Arthritis
- What is being tested?
- Custom fabricated elbow extension orthosis
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Elbow Injury, Elbow Fracture, Elbow Arthritis
- Being tested
- Custom fabricated elbow extension orthosis
- Medical subject headings
- Elbow Injuries, Elbow Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom fabricated elbow extension orthosisDevice
custom low temperature thermoplastic orthosis (Splint) holding the elbow in maximum extension at night
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthosis wearing time (sensor measured)
overall time in orthosis as measured by the sensor
Measured: 6 weeks
Orthosis wearing time (self-reported)
overall time in orthosis reported by the patient
Measured: 6 weeks
Secondary outcomes (2)
Elbow ROM
goniometric measurement
Measured: 6 months
Patient Rated Elbow Evaluation
patient reported outcome measure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow InjuryStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437133
- Sponsor's protocol ID
- 12567
- Status last verified
- Jun 2022
- First submitted
- 23 Jun 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of Self-reported Adherence to Elbow Orthosis Wearing Time Using Concealed Temperature Sensors
- ClinicalTrials.gov ID
- NCT05437133
- Acronym / sponsor ID
- 12567
- Conditions
- Elbow Injury, Elbow Fracture, Elbow Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custom fabricated elbow extension orthosiscustom low temperature thermoplastic orthosis (Splint) holding the elbow in maximum extension at night | Device | – |
Primary outcome
Orthosis wearing time (sensor measured)
Time frame: 6 weeks
overall time in orthosis as measured by the sensor
Orthosis wearing time (self-reported)
Time frame: 6 weeks
overall time in orthosis reported by the patient
2 secondary outcomes
Elbow ROM
Time frame: 6 months
Patient Rated Elbow Evaluation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Elbow Injury and Elbow Fracture, run by Western University, Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthosis wearing time (sensor measured) (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022.