None listed
Conditions
Brief summary
Currently, patient reported outcome measures (PROMs) such as the Oswestry Disability Index (ODI) and Visual Analogue Scale (VAS) are the standard method to assess improvement after spine surgery. However, these measures are subjective and do not provide an objective measure of physical capacity. To provide patients with an accurate representation of their function, it seems most beneficial to provide patients with a standardised objective tool which reflects the requirements of daily living. However, the necessary equipment needed to conduct some of these tests may not be accessible for some clinicians. Therefore, the aim of this study is to develop a tool which can be easily and reliably administered within clinical practice. The hypothesis of this study is that test scores are responsive to changes over time, more so than the standard measures of pain (VAS) and disability (ODI). The secondary hypothesis is that changes in clinical tests (e.g. the fingertip to floor) will correlate with the changes seen in their objective counterparts (e.g. the DorsaVi wearable sensors).
Interventions
This is a longitudinal study with the goal of creating a functional protocol that can be administered to patients following lumbar fusion surgery, the purpose of which is to assess a patient's trunk strength, balance, and flexibility. It is important to note that patients who are already scheduled to receive a lumbar fusion will be approached for participation. While not all patients will participate, those who do will be asked to complete the functional assessment pre-operatively, and then repeat it 8 weeks and 6 months (primary timepoint) post-surgery. The functional assessment: An exercise professional (either an Exercise Scientist or Exercise Physiologist) is responsible for administering the protocol at baseline, and at the subsequent post-operative appointments. These appointments take place at the BackSpace clinic in the Brisbane Private Hospital and take 60-minutes to complete. The protocol aims to assess four primary domains, being that of trunk strength, balance, flexibility, and activities of daily living. Trunk strength: The exercise professional will instruct the participant to perform four tests that aim to assess trunk strength and endurance. A force plate will be used to assess strength through trunk flexion and extension. To assess endurance, the McGill 60-second Core Endurance test and a Trunk Extensor Endurance test will be used. Balance: The exercise professional will instruct the participant to perform tests of both static and dynamic balance. These include: the Four Square Step test, the Romberg Standing Balance, and the 30-second single-leg stand. Static balance tests will be conducted using the VALD ForceDecks, which measure changes in centre of pressure over time. Flexibility: The exercise professional will place wearable motion censors onto the participant and will instruct them to move through trunk flexion, extension, lateral flexion, and rotation. Additional tests consist of the Fingertip to Floor test, and a combined test of trunk extension, lateral flexion, and rotation. Lower limb strength and mobility: The exercise professional will instruct the participant to perform two primary tests, being the 30-second Sit-to-Stand and the Timed-Up and Go test. PROMs: At each of their respective visits, the participants will be asked to complete three subjective questionnaires. The questionnaires include: the Oswestry Disability Index and the Visual Analogue Scale. Additionally, at the 6-month time point, participants will be asked to complete the Global Perceived Effect scale. The novelty of this project is encompassed by two primary aspects; the first comes with the inclusion of novel assessments which have yet to be validated. These tests include all of the VALD ForceFrame testing, the Trunk Extensor Endurance test, and the Multi-Planar Reach test. The seconds comes from combining these tests into a single protocol.
Sponsors
Eligibility
Inclusion criteria
Aged 18 years or older and undergoing a one or two level lumbar spinal fusion surgery
Exclusion criteria
- Active compensation or litigation claim - Active musculoskeletal limitation - Medically unsuitable as determined by the treating spine surgeon