Efficacy of a Remotely Administered Functional Capacity Test on Return-to-work Outcomes

NCT ID: NCT05370872

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-03-31

Brief Summary

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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

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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

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Low Back Disorder Shoulder Disease Musculoskeletal Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors
The individual responsible for comparing return-to-work outcome between groups will be blind to the group assignments

Study Groups

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Care-as-usual

Clients in this group will complete functional testing in the clinic using the care-as-usual approach.

Group Type NO_INTERVENTION

No interventions assigned to this group

Remote functional testing

Clients in this group will complete functional testing using the remote functional testing approach.

Group Type EXPERIMENTAL

Remote functional testing protocol

Intervention Type DIAGNOSTIC_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.

Interventions

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Remote functional testing protocol

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CBI Health

UNKNOWN

Sponsor Role collaborator

University of Waterloo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steve Fischer

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, University of Waterloo

Locations

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CBIH London Dundas

London, Ontario, Canada

Site Status

CBIH London Fanshawe

London, Ontario, Canada

Site Status

CBIH London Wonderland

London, Ontario, Canada

Site Status

CBIH Nepean

Nepean, Ontario, Canada

Site Status

CBIH St. Laurent

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT
PMID: 24374369 (View on PubMed)

Other Identifiers

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44076

Identifier Type: -

Identifier Source: org_study_id

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