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Trial registered on ANZCTR


Registration number
ACTRN12618001945213p
Ethics application status
Submitted, not yet approved
Date submitted
9/11/2018
Date registered
30/11/2018
Date last updated
14/12/2018
Date data sharing statement initially provided
30/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A new reliable, valid and responsive measure for lumbar spinal stenosis
Scientific title
Determining the reliability, validity and responsiveness of a low-cost activity monitor for assessing walking in patients with lumbar spinal stenosis
Secondary ID [1] 296558 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lumbar spinal stenosis 310359 0
Condition category
Condition code
Musculoskeletal 309089 309089 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants with symptoms of LSS, confirmed with diagnostics (i.e MRI or CT) and who are undergoing single-level or dual level decompression surgery will be asked to complete two Self-Paced Walking Tests (SPWT), 7 days apart before surgery, and then again 6 weeks after surgery. The SPWT will be completed as per Tomkins-Lane protocol, with patients walking for up to 30 minutes on a flat track, or until they are forced to stop due to the LSS symptoms that normally cause them to stop. Patients will be monitored throughout.

At the 1st visit, patients will also be given an activity monitor device and a free walking app (health kit app for apple devices and google fit app for android devices) that participants will carry with them throughout the SPWT.
Participants will also be asked to complete a set of self-reported walking measures (the Oswestry Disability Index (ODI) walking section, the Physical Function scale (of the Swiss Spinal Stenosis Questionnaire) and a question of self-perceived recovery, using a 7 point Likert scale where 1 is ‘worse than ever’, and 7 is ‘completely recovered’).
Intervention code [1] 312875 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308053 0
For criterion validity, a correlation coefficient of greater than or equal to 0.80 with the Self-paced walking test will be considered adequate criterion validity


Timepoint [1] 308053 0
Criterion validity timepoint: 1st visit

Primary outcome [2] 308242 0
For test re-test reliability, an intraclass correlation coefficient of greater than or equal to 0.70 for the activity monitor will be considered adequate test re-test reliability
Timepoint [2] 308242 0
Test re-test reliability: 2nd visit (7 days following 1st visit)
Primary outcome [3] 308243 0
For responsiveness, an area under the curve of greater than or equal to 0.70 will be considered adequate responsiveness for the activity monitor.
Timepoint [3] 308243 0
Responsiveness: 6 weeks following decompressive spinal surgery
Secondary outcome [1] 354363 0
Participant's self-perceived recovery, using a 7 point Likert scale where 1 is ‘worse than ever’, and 7 is ‘completely recovered’. A score of 6 ("recovered") or greater will be considered recovered.
Timepoint [1] 354363 0
6 weeks following decompressive surgery
Secondary outcome [2] 354556 0
The criterion validity will be assessed for the Oswestry disability Index (ODI) walk item, with a correlation coefficient of greater than or equal to 0.80 with the Self-paced walking test considered adequate criterion validity
Timepoint [2] 354556 0
Criterion validity timepoint: 1st visit
Secondary outcome [3] 354557 0
The criterion validity will be assessed for the Physical Function Scale, with a correlation coefficient of greater than or equal to 0.80 with the Self-paced walking test considered adequate criterion validity
Timepoint [3] 354557 0
Criterion validity timepoint: 1st visit
Secondary outcome [4] 354558 0
The criterion validity will be assessed for the walking phone app, with a correlation coefficient of greater than or equal to 0.80 with the Self-paced walking test considered adequate criterion validity
Timepoint [4] 354558 0
Criterion validity timepoint: 1st visit

Eligibility
Key inclusion criteria
symptoms of lumbar spinal stenosis; imaging confirming central stenosis; scheduled for decompressive spinal surgery; ability to walk unaided
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of comorbid conditions affecting walking (i.e. hip osteoarthritis); vascular claudication

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
100 participants are required to adhere to the recommendations for sample size (when assessing measurement properties) from COSMIN.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12382 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 12383 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [3] 12384 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [4] 12385 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 24649 0
2139 - Concord
Recruitment postcode(s) [2] 24650 0
2031 - Randwick
Recruitment postcode(s) [3] 24651 0
2109 - Macquarie Park
Recruitment postcode(s) [4] 24652 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 301137 0
University
Name [1] 301137 0
The University of Sydney
Address [1] 301137 0
Kolling institute, Royal North Shore Hospital Pacific Highway, St Leonards New South Wales 2065
Country [1] 301137 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Kolling institute, Royal North Shore Hospital Pacific Highway, St Leonards New South Wales 2065
Country
Australia
Secondary sponsor category [1] 300757 0
None
Name [1] 300757 0
Address [1] 300757 0
Country [1] 300757 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301886 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 301886 0
The University of Sydney Human Research Ethics Committee
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 301886 0
Australia
Date submitted for ethics approval [1] 301886 0
08/11/2018
Approval date [1] 301886 0
Ethics approval number [1] 301886 0

Summary
Brief summary
This trial is designed to assess the validity, reliability and responsiveness of an activity monitor, free walking app, ODI walk item, PFS and self-paced walking test
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88438 0
Mr David Anderson
Address 88438 0
Kolling Institute, Royal North Shore Hospital Pacific Highway, St Leonards New South Wales 2065
Country 88438 0
Australia
Phone 88438 0
+61 (02) 9926 4500
Fax 88438 0
Email 88438 0
dand3231@uni.sydney.edu.au
Contact person for public queries
Name 88439 0
Mr David Anderson
Address 88439 0
Kolling Institute, Royal North Shore Hospital Pacific Highway, St Leonards New South Wales 2065
Country 88439 0
Australia
Phone 88439 0
+61 (02) 9926 4500
Fax 88439 0
Email 88439 0
dand3231@uni.sydney.edu.au
Contact person for scientific queries
Name 88440 0
Mr David Anderson
Address 88440 0
Kolling Institute, Royal North Shore Hospital Pacific Highway, St Leonards New South Wales 2065
Country 88440 0
Australia
Phone 88440 0
+61 (02) 9926 4500
Fax 88440 0
Email 88440 0
dand3231@uni.sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
May be provided after discussions with journal publishers
What supporting documents are/will be available?
No other documents available
Summary results
No Results