Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001389796
Ethics application status
Approved
Date submitted
13/10/2022
Date registered
31/10/2022
Date last updated
21/01/2024
Date data sharing statement initially provided
31/10/2022
Date results information initially provided
21/01/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The development of a functional assessment tool for patients undergoing lumbar spinal fusion surgery
Scientific title
Validity and responsiveness of a new functional assessment tool for patients undergoing lumbar fusion surgery
Secondary ID [1] 308170 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lumbar degenerative disc disease 327890 0
Spondylolisthesis 327891 0
Condition category
Condition code
Musculoskeletal 324977 324977 0 0
Other muscular and skeletal disorders
Surgery 324978 324978 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 324615 0
Diagnosis / Prognosis
Comparator / control treatment
Each of the testing domains, whether it be strength, balance, or flexibility includes assessment which can be seen as either "clinical" or "objective". This intention behind this to determine whether the results from the different testing methods correlate, and can therefore be validated for clinical practice. All of the tests will be conducted in a single session and will take approximately 60-minutes to complete.

Strength: changes in trunk flexor strength shown on the VALD ForceFrame will be correlated and validated against those seen in the McGill 60-second Endurance Test. Changes in trunk extensor strength shown on the VALD ForceFrame will be correlated and validated against those seen in the Trunk Extensor Endurance Test.

Balance: changes in static balance as shown on the VALD ForceDecks will be correlated and validated against the results given via the Romberg Standing Balance test and the 30-second Single Leg Balance test.

Flexibility: changes in trunk flexion range of motion as shown by the wearable sensors will be correlated against the Finger-Tip-to-Floor test. Changes in trunk rotation, lateral flexion, and extension as shown via the Multi-planar Reach test will be correlated and validated against the results given by the wearable sensors.
Control group
Active

Outcomes
Primary outcome [1] 332795 0
Changes in trunk flexor strength will be assessed via the VALD ForceFrame
Timepoint [1] 332795 0
Baseline, 8-weeks and 6-month (primary timepoint) post surgery
Primary outcome [2] 332796 0
Changes in standing balance will be assessed by the VALD ForceDecks
Timepoint [2] 332796 0
Baseline, 8 weeks, and 6 months (primary timepoint) post surgery
Primary outcome [3] 332797 0
Changes in trunk flexion range-of-motion will be assessed via the DorsaVi wearable sensors
Timepoint [3] 332797 0
Baseline, 8 weeks, and 6 months (primary timepoint) post surgery
Secondary outcome [1] 414911 0
Changes in trunk flexor strength will be assessed via the McGill 60-second Core Endurance test
Timepoint [1] 414911 0
Baseline, 8-weeks, and 6-months post surgery
Secondary outcome [2] 414912 0
Changes in trunk extensor strength will be assessed via the VALD ForceFrame
Timepoint [2] 414912 0
Baseline, 8-weeks, and 6-months post surgery
Secondary outcome [3] 414913 0
Changes in trunk extensor strength will be assessed via the Trunk Extensor Endurance Test
Timepoint [3] 414913 0
Baseline, 8-weeks, and 6-months post surgery
Secondary outcome [4] 414914 0
Changes in dynamic balance will be assessed via the Four Square Step test
Timepoint [4] 414914 0
Baseline, 8-weeks, and 6-months post surgery
Secondary outcome [5] 414915 0
Changes in flexibility will be assessed via the Finger Tip to Floor test
Timepoint [5] 414915 0
Baseline, 8-weeks, and 6-months post surgery
Secondary outcome [6] 414916 0
Changes in flexibility will be assessed via the Multi-planar Reach test
Timepoint [6] 414916 0
Baseline, 8-weeks, and 6-months post surgery
Secondary outcome [7] 414917 0
Changes in trunk extension range of motion will be assessed via the DorsaVi wearable sensors
Timepoint [7] 414917 0
Baseline, 8-weeks, and 6-months post surgery
Secondary outcome [8] 414918 0
Changes in trunk lateral flexion range of motion will be assessed via the DorsaVi wearable sensors
Timepoint [8] 414918 0
Baseline, 8-weeks, and 6-months post surgery
Secondary outcome [9] 414919 0
Changes in trunk rotation range of motion will be assessed via the DorsaVi wearable sensors
Timepoint [9] 414919 0
Baseline, 8-weeks, and 6-months post surgery
Secondary outcome [10] 414920 0
Changes in lower limb strength will be assessed using the 30-second Sit-to-Stand
Timepoint [10] 414920 0
Baseline, 8-weeks, and 6-months post surgery
Secondary outcome [11] 414921 0
Changes in mobility will be assessed using the Timed-Up and Go test
Timepoint [11] 414921 0
Baseline, 8-weeks, and 6-months post surgery
Secondary outcome [12] 414922 0
The participants subjective sense of their own improvement will be assessed using the Global Perceived Effect (GPE) questionnaire
Timepoint [12] 414922 0
Baseline, 8-weeks, 6-months
Secondary outcome [13] 414923 0
Changes in disability will be assessed using the Oswestry Disability Index (ODI)
Timepoint [13] 414923 0
Baseline, 8-weeks, and 6-months post surgery
Secondary outcome [14] 414924 0
Changes in pain will be assessed using the Visual Analogue Scale (VAS)
Timepoint [14] 414924 0
Baseline, 8-weeks, and 6-months post surgery
Secondary outcome [15] 415262 0
Changes in standing balance will be assessed via the Romberg Standing Balance test
Timepoint [15] 415262 0
Baseline, 8-weeks, and 6-months post surgery
Secondary outcome [16] 415263 0
Changes in single leg balance will be assessed via the 30-second single-leg balance test
Timepoint [16] 415263 0
Baseline, 8-weeks, and 6-months post surgery

Eligibility
Key inclusion criteria
Aged 18 years or older and undergoing a one or two level lumbar spinal fusion surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Active compensation or litigation claim
- Active musculoskeletal limitation
- Medically unsuitable as determined by the treating spine surgeon

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
10/03/2022
Date of last participant enrolment
Anticipated
Actual
31/08/2023
Date of last data collection
Anticipated
5/03/2024
Actual
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23369 0
Brisbane Private Hospital - Brisbane
Recruitment postcode(s) [1] 38750 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 312428 0
Commercial sector/Industry
Name [1] 312428 0
Johnson & Johnson Medical Pty Ltd.
Country [1] 312428 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
SpinePlus Pty Ltd.
Address
Level 7, 259 Wickham Terrace, Brisbane City, Queensland, 4000
Country
Australia
Secondary sponsor category [1] 314014 0
None
Name [1] 314014 0
Address [1] 314014 0
Country [1] 314014 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311773 0
Brisbane Private Hospital Low Risk Ethics Review Committee
Ethics committee address [1] 311773 0
259 Wickham Terrace, Brisbane City, Queensland, 4000
Ethics committee country [1] 311773 0
Australia
Date submitted for ethics approval [1] 311773 0
18/07/2021
Approval date [1] 311773 0
01/09/2021
Ethics approval number [1] 311773 0
LREC21BPH3

Summary
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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122318 0
A/Prof Paul Licina
Address 122318 0
SpinePlus, Level 7, 259 Wickham Terrace, Brisbane City, Queensland, 4000
Country 122318 0
Australia
Phone 122318 0
+61413427047
Fax 122318 0
Email 122318 0
plicina@spineplus.com.au
Contact person for public queries
Name 122319 0
Mr Patrick Beaumont
Address 122319 0
SpinePlus, Level 7, 259 Wickham Terrace, Brisbane City, Queensland, 4000
Country 122319 0
Australia
Phone 122319 0
+61413427047
Fax 122319 0
Email 122319 0
patrick@spineplus.com.au
Contact person for scientific queries
Name 122320 0
A/Prof Paul Licina
Address 122320 0
SpinePlus, Level 7, 259 Wickham Terrace, Brisbane City, Queensland, 4000
Country 122320 0
Australia
Phone 122320 0
+61413427047
Fax 122320 0
Email 122320 0
research@spineplus.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification, all of the individual participant data will be shared
When will data be available (start and end dates)?
Data will be available immediately following publication and for 5 years following publication
Available to whom?
Data will be available after dissemination upon request and at the discretion of the sponsor. The data will only be distributed to researchers.
Available for what types of analyses?
Data will be available for primary and secondary analysis on the basis that the secondary analysis is related to the topic.
How or where can data be obtained?
Access is subject to approvals by the Principal Investigator.
Email: research@spineplus.com.au
Contact number: 0413 427 048


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.