Low Back DisorderNCT05370872
Efficacy of a Remotely Administered Functional Capacity Test on Return-to-work Outcomes
A study testing Remote functional testing protocol in people with Low Back Disorder and Shoulder Disease, run by University of Waterloo at 5 sites in Canada.
Trial summary
Currently, injured workers are required to visit a clinic, in-person, for functional testing as part of the rehabilitation and return-to-work process. The need for in-person testing has always caused problems for workers in remote areas without easy access to clinics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Disorder, Shoulder Disease, Musculoskeletal Injury
- What is being tested?
- Remote functional testing protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 5 sitesCanada
- Study dates
- 1 Nov 2022to 31 Mar 2024
- Phase
- Interventional
- 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
Who may be able to join
- Injured workers with accepted Workplace Safety and Insurance Board (WSIB) of Ontario claims referred to CBI Health for WSIB Specialty Programs related to musculoskeletal injuries of either Back and Neck, or Upper Extremity.
Who cannot join
- Under the age of 18 years,
- referred for surgery during the time of the rehabilitation programming,
- have a concurrent traumatic brain injury or mental health disorder that takes precedence over the musculoskeletal injury, or
- require the assistance of an interpreter to read, write or speak English.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
CBIH London Dundas
London, Ontario, N5W 3C6
CBIH London Fanshawe
London, Ontario, N6G 0W7
CBIH London Wonderland
London, Ontario, N6K 3X4
CBIH Nepean
Nepean, Ontario, K2H 5V6
CBIH St. Laurent
Ottawa, Ontario, K1K 4H4
About this study
Official title: Efficacy of a Remotely Administered Functional Capacity Test on Return-to-work Outcomes: a Cluster Randomized Controlled Trial
Currently, injured workers are required to visit a clinic, in-person, for functional testing as part of the rehabilitation and return-to-work process. The need for in-person testing has always caused problems for workers in remote areas without easy access to clinics. COVID-19 has made the problem of access to in-person clinical testing worse. Now, many injured workers can't receive functional testing due to COVID-19 related clinic closures and isolation restrictions. The investigators aim to develop and evaluate a functional testing protocol that can be delivered remotely to solve the problem of access to in-person clinic testing. A functional test that can be completed remotely, while the client remains in their home will increase access to timely testing, improve client satisfaction by removing the need for costly and time consuming travel, and will continue to help injured workers quickly recover and return to meaningful work. This research study will help to determine if return-to-work outcomes improve, or remain unchanged, when functional testing is completed remotely relative to in the clinic.
Read the detailed description
Functional testing, often referred to as functional capacity evaluation (FCE) has played a longstanding role within return-to-work (RTW). The goal of an FCE is to measure an assess an individual's functional capabilities (e.g., how much can the client lift? How hard can the client push? Can the client sit for a long period of time? etc.). Historically, FCE served to measure the degree of disability (i.e., reduction in physical capability) following a workplace injury and also helped to match workers with meaningful work suited to their (adapted) functional abilities. Presently, performance-based FCE, testing requiring clients to perform movements with different weighted objects (for instance, to measure how much someone can lift), is collected at patient intake to provide a functional capacity baseline which, in turn, informs patient-centered rehabilitation programming. Not only does this FCE information help support job matching when applied at the end stages of rehabilitation (fitting clients to work based on the adapted functional capabilities), but when applied early with the rehabilitation program, FCE also provides key insights to inform patient-centred rehabilitative strategies and work hardening approaches. FCE plays a central role in supporting early and safe RTW.
However, accessing in-person, in-clinic administered functional testing to provide these important baseline insights has been a longstanding problem in remote and rural communities, a problem now amplified by clinic disruptions and temporary closures across Ontario, Canada. COVID-19 has intensified the problem of the in-person, in-clinic requirements for baseline functional testing where many injured workers are unable to access or are delayed in accessing important FCE services. The lack of patient-specific information regarding functional abilities via baseline FCE is a direct barrier to patient-centered rehabilitation and limits early and safe RTW. To address this problem, the investigators test the efficacy of a remotely administered functional testing protocol as an alternative to in-person, in-clinic baseline functional testing.
The concept of a remotely delivered baseline FCE is not new, but has been limited to subjective self-report-based methods only (e.g., asking a client how much they think they can lift). Gross et al., (2014) provide evidence that a functional interviewing-based FCE (currently deployed within the Workers' Compensation Board - Alberta, Canada system) was equivalently useful in predicting RTW outcomes relative to performance-based FCE. However, performance-based FCE elements, such as low lifting tests also remain useful for predicting RTW outcomes and provide objective insight about movement characteristics. Observing how a client moves when performing a lift, for example, provides insight into their willingness to engage, any guarding behaviours they may exhibit, any observed hesitancy to move, and also provides insight into their coordination of movement. These insights are necessary to inform patient centered rehabilitation programming and to ensure that the care team has the necessary health professionals (i.e., rehabilitation to address mechanical issues relative to psychosocial barriers). The investigators believe that a hybrid FCE including self-report to estimate maximum functional levels combined with a safe, submaximal performance-based FCE to assess movement characteristics can provide key insights to best optimize early and safe RTW when using virtual FCE delivery. However, at present, no such testing paradigm exists.
To optimize remote FCE service delivery to include both self-report and performance-based insights, the investigators aim to leverage the 2D video recording capabilities of Microsoft Teams, the CBI Health approved software application for safely and securely engaging with clients remotely. The investigators have demonstrated how movement data (which can be generated using 2D video and pose estimation) and advances in computer vision can be leveraged to generate insightful information about key movement characteristics, functional capabilities and safety. The ability for a patient to record their performance of safe, standardized, sub-maximal actions will generate essential and objective information to support patient-centered rehabilitative programing, an integral requirement for early and safe RTW.
The investigators have developed an evidence-based protocol for remote delivery of baseline functional testing for injured workers inclusive of performance-based and self-report FCE measures. The investigators now aim to evaluate if a remotely administered functional testing protocol can generate treatment recommendations and RTW outcomes that are consistent with the current status quo requiring in-person, in-clinic functional assessment. The investigators hypothesize that the remotely administered functional testing protocol will yield similar insight to in-person, in-clinic baseline FCE, such that RTW outcomes will be equal to or better when using the remotely administered functional testing protocol. The investigators also hypothesize that patient experience and satisfaction will be improved with the use of a remotely administered functional testing protocol because time and cost intensive travel barriers can be removed.
- Conditions
- Low Back Disorder, Shoulder Disease, Musculoskeletal Injury
- Being tested
- Remote functional testing protocol
- Keywords
- Functional capacity evaluation, Return to work, Functional testing, Motivational interviewing, Telehealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote functional testing protocolDiagnostic test
Clients in the remote functional testing protocol group will be asked to describe their functional capacity limits using a clinician guided motivational interviewing approach and will also be asked to complete a mobility screening protocol to provide the clinician with the opportunity to observe the clients natural movements.
| Study group | Role | What they receive |
|---|---|---|
| Care-as-usual | No intervention | Clients in this group will complete functional testing in the clinic using the care-as-usual approach. |
| Remote functional testing | Experimental | Clients in this group will complete functional testing using the remote functional testing approach. Receives: Diagnostic Test: Remote functional testing protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work recommendation at intake
When referred to an musculoskeletal program of care, clients are classified into return to work categories based on their ability to meet job requirements as measured by the clinician using the functional testing protocol. The return to work recommendation at intake is used to inform the rehabilitation program.
Measured: Baseline measure - a intake into the rehabilitation program
Return to work recommendation at discharge
Once the client has completed a musculoskeletal program of care, clients are again classified into return to work categories based on their ability to meet job requirements as measured by the clinician using the functional testing protocol. The return to work recommendation at discharge is used to inform how the client is reintegrated into their workplace.
Measured: At program discharge (approximately 8-12 weeks post intake, where each client will receive a tailored program based on their return to work recommendation at intake)
Return to work status
Clients will be aske to describe their current work status at three-months post discharge by selecting 1 of 5 options (work regular, full time duties; work regular, part time duties, work light duty or modified position full time; work light duty or modified position part time; not currently working)
Measured: three-months post discharge
Secondary outcomes (2)
Adverse events
Reports of adverse events for participating clients will be extracted from the occupational health \& safety document management system.
Measured: Through study completion, and average of 1 year
Client experience and satisfaction
Clients will complete a web survey inclusive of 3 questions that probe their experience and satisfaction with the functional testing that they received. Each question is posed using a 5-point Likert scale (strongly disagree, disagree, neither agree or disagree, agree, strongly agree).
Measured: one-week post initial functional testing session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 Nov 2022
- Primary completion31 Dec 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial. Clinicians will be randomly assigned to administer the functional testing protocol in-person (care-as-usual) or remotely (the intervention). Clients will complete the functional testing protocol based on the group assignment of the clinician to whom they were referred to.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- CBI Health
- Responsible party
- Sponsor
- Investigators
- Steve Fischer, Principal investigator, Associate Professor, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370872
- Sponsor's protocol ID
- 44076
- Status last verified
- Nov 2022
- First submitted
- 2 May 2022
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Publications
Gross DP, Asante AK, Miciak M, Battie MC, Carroll LJ, Sun A, Mikalsky M, Huellstrung R, Niemelainen R. A cluster randomized clinical trial comparing functional capacity evaluation and functional interviewing as components of occupational rehabilitation programs. J Occup Rehabil. 2014 Dec;24(4):617-30. doi: 10.1007/s10926-013-9491-4.
PubMed 24374369
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Remotely Administered Functional Capacity Test on Return-to-work Outcomes: a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05370872
- Acronym / sponsor ID
- 44076
- Conditions
- Low Back Disorder, Shoulder Disease, Musculoskeletal Injury
- Keywords
- Functional capacity evaluation, Return to work, Functional testing, Motivational interviewing, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- CBI Health
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 12 May 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.
Currently, injured workers are required to visit a clinic, in-person, for functional testing as part of the rehabilitation and return-to-work process. The need for in-person testing has always caused problems for workers in remote areas without easy access to clinics. COVID-19 has made the problem of access to in-person clinical testing worse. Now, many injured workers can't receive functional testing due to COVID-19 related clinic closures and isolation restrictions. The investigators aim to develop and evaluate a functional testing protocol that can be delivered remotely to solve the problem of access to in-person clinic testing. A functional test that can be completed remotely, while the client remains in their home will increase access to timely testing, improve client satisfaction by removing the need for costly and time consuming travel, and will continue to help injured workers quickly recover and return to meaningful work. This research study will help to determine if return-to-work outcomes improve, or remain unchanged, when functional testing is completed remotely relative to in the clinic.
Detailed description
Functional testing, often referred to as functional capacity evaluation (FCE) has played a longstanding role within return-to-work (RTW). The goal of an FCE is to measure an assess an individual's functional capabilities (e.g., how much can the client lift? How hard can the client push? Can the client sit for a long period of time? etc.). Historically, FCE served to measure the degree of disability (i.e., reduction in physical capability) following a workplace injury and also helped to match workers with meaningful work suited to their (adapted) functional abilities. Presently, performance-based FCE, testing requiring clients to perform movements with different weighted objects (for instance, to measure how much someone can lift), is collected at patient intake to provide a functional capacity baseline which, in turn, informs patient-centered rehabilitation programming. Not only does this FCE information help support job matching when applied at the end stages of rehabilitation (fitting clients to work based on the adapted functional capabilities), but when applied early with the rehabilitation program, FCE also provides key insights to inform patient-centred rehabilitative strategies and work hardening approaches. FCE plays a central role in supporting early and safe RTW.
However, accessing in-person, in-clinic administered functional testing to provide these important baseline insights has been a longstanding problem in remote and rural communities, a problem now amplified by clinic disruptions and temporary closures across Ontario, Canada. COVID-19 has intensified the problem of the in-person, in-clinic requirements for baseline functional testing where many injured workers are unable to access or are delayed in accessing important FCE services. The lack of patient-specific information regarding functional abilities via baseline FCE is a direct barrier to patient-centered rehabilitation and limits early and safe RTW. To address this problem, the investigators test the efficacy of a remotely administered functional testing protocol as an alternative to in-person, in-clinic baseline functional testing.
The concept of a remotely delivered baseline FCE is not new, but has been limited to subjective self-report-based methods only (e.g., asking a client how much they think they can lift). Gross et al., (2014) provide evidence that a functional interviewing-based FCE (currently deployed within the Workers' Compensation Board - Alberta, Canada system) was equivalently useful in predicting RTW outcomes relative to performance-based FCE. However, performance-based FCE elements, such as low lifting tests also remain useful for predicting RTW outcomes and provide objective insight about movement characteristics. Observing how a client moves when performing a lift, for example, provides insight into their willingness to engage, any guarding behaviours they may exhibit, any observed hesitancy to move, and also provides insight into their coordination of movement. These insights are necessary to inform patient centered rehabilitation programming and to ensure that the care team has the necessary health professionals (i.e., rehabilitation to address mechanical issues relative to psychosocial barriers). The investigators believe that a hybrid FCE including self-report to estimate maximum functional levels combined with a safe, submaximal performance-based FCE to assess movement characteristics can provide key insights to best optimize early and safe RTW when using virtual FCE delivery. However, at present, no such testing paradigm exists.
To optimize remote FCE service delivery to include both self-report and performance-based insights, the investigators aim to leverage the 2D video recording capabilities of Microsoft Teams, the CBI Health approved software application for safely and securely engaging with clients remotely. The investigators have demonstrated how movement data (which can be generated using 2D video and pose estimation) and advances in computer vision can be leveraged to generate insightful information about key movement characteristics, functional capabilities and safety. The ability for a patient to record their performance of safe, standardized, sub-maximal actions will generate essential and objective information to support patient-centered rehabilitative programing, an integral requirement for early and safe RTW.
The investigators have developed an evidence-based protocol for remote delivery of baseline functional testing for injured workers inclusive of performance-based and self-report FCE measures. The investigators now aim to evaluate if a remotely administered functional testing protocol can generate treatment recommendations and RTW outcomes that are consistent with the current status quo requiring in-person, in-clinic functional assessment. The investigators hypothesize that the remotely administered functional testing protocol will yield similar insight to in-person, in-clinic baseline FCE, such that RTW outcomes will be equal to or better when using the remotely administered functional testing protocol. The investigators also hypothesize that patient experience and satisfaction will be improved with the use of a remotely administered functional testing protocol because time and cost intensive travel barriers can be removed.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial. Clinicians will be randomly assigned to administer the functional testing protocol in-person (care-as-usual) or remotely (the intervention). Clients will complete the functional testing protocol based on the group assignment of the clinician to whom they were referred to.
| Arm | Type | Receives |
|---|---|---|
| Care-as-usual | No intervention | –Clients in this group will complete functional testing in the clinic using the care-as-usual approach. |
| Remote functional testing | Experimental | Diagnostic Test: Remote functional testing protocolClients in this group will complete functional testing using the remote functional testing approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Injured workers with accepted Workplace Safety and Insurance Board (WSIB) of Ontario claims referred to CBI Health for WSIB Specialty Programs related to musculoskeletal injuries of either Back and Neck, or Upper Extremity.
Key exclusion criteria (4 listed)
- Under the age of 18 years,
- referred for surgery during the time of the rehabilitation programming,
- have a concurrent traumatic brain injury or mental health disorder that takes precedence over the musculoskeletal injury, or
- require the assistance of an interpreter to read, write or speak English.
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 |
|---|---|---|
| Remote functional testing protocolClients in the remote functional testing protocol group will be asked to describe their functional capacity limits using a clinician guided motivational interviewing approach and will also be asked to complete a mobility screening protocol to provide the clinician with the opportunity to observe the clients natural movements. | Diagnostic test | Remote functional testing |
Primary outcome
Return to work recommendation at intake
Time frame: Baseline measure - a intake into the rehabilitation program
When referred to an musculoskeletal program of care, clients are classified into return to work categories based on their ability to meet job requirements as measured by the clinician using the functional testing protocol. The return to work recommendation at intake is used to inform the rehabilitation program.
Return to work recommendation at discharge
Time frame: At program discharge (approximately 8-12 weeks post intake, where each client will receive a tailored program based on their return to work recommendation at intake)
Once the client has completed a musculoskeletal program of care, clients are again classified into return to work categories based on their ability to meet job requirements as measured by the clinician using the functional testing protocol. The return to work recommendation at discharge is used to inform how the client is reintegrated into their workplace.
Return to work status
Time frame: three-months post discharge
Clients will be aske to describe their current work status at three-months post discharge by selecting 1 of 5 options (work regular, full time duties; work regular, part time duties, work light duty or modified position full time; work light duty or modified position part time; not currently working)
2 secondary outcomes
Adverse events
Time frame: Through study completion, and average of 1 year
Client experience and satisfaction
Time frame: one-week post initial functional testing session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Results publication: PubMed 24374369Gross DP, Asante AK, Miciak M, Battie MC, Carroll LJ, Sun A, Mikalsky M, Huellstrung R, Niemelainen R. A cluster randomized clinical trial comparing functional capacity evaluation and functional interviewing as components of occupational rehabilitation programs. J Occup Rehabil. 2014 Dec;24(4):617-30. doi: 10.1007/s10926-013-9491-4.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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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.
Steve Fischer principal investigator
Associate Professor, University of Waterloo
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote functional testing protocol in people with Low Back Disorder and Shoulder Disease, run by University of Waterloo at 5 sites in 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 4 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: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Return to work recommendation at intake (time frame: Baseline measure - a intake into the rehabilitation program). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05370872, which also lists 1 linked publication.
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 16 Apr 2024.