Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000171617
Ethics application status
Approved
Date submitted
3/02/2023
Date registered
20/02/2023
Date last updated
20/02/2023
Date data sharing statement initially provided
20/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring Sitting Balance in People with Acute or Subacute Spinal Cord Injury
Scientific title
Psychometric properties and clinical utility of sitting balance outcome measures in the acute or subacute spinal cord injury population.
Secondary ID [1] 308891 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 327199 0
Condition category
Condition code
Physical Medicine / Rehabilitation 324337 324337 0 0
Physiotherapy
Physical Medicine / Rehabilitation 324338 324338 0 0
Occupational therapy
Neurological 324339 324339 0 0
Other neurological disorders
Injuries and Accidents 325973 325973 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Three balance outcome measures, the Function in Sitting Test for people with spinal cord injury (FIST-SCI), the Modified FIST, and the Trunk Control Test (TCT), will be used to assess balance in individuals <6 months post-SCI. There will be 3 physiotherapist assessors (Rater A, B, C) who repeat the testing 4 times within 10 days (A1, A2, B, C) and then one more time 6-weeks after the initial assessment (A3). Assessor order will be randomized for the first 4 assessments (eg. [B, A1, C, A2] or [A1, C, B, A2]). The assessor who leads two of the testing sessions (Rater A: A1, A2) in the first 10 days will also be the assessor to complete the 6-week follow-up assessment session (A3). Participants in the study will complete the assessments during their inpatient stay in a physiotherapy gym. In all, participants complete each test 5 times. We estimate that a single study session, were all three of the assessments are completed, will take 25-35 minutes. There will only be one testing session per day. Testing sessions will be scheduled to not interfere with the medical care of the participant.
Intervention code [1] 324143 0
Not applicable
Comparator / control treatment
While there is not true 'gold standard' of stilling balance and trunk control in people with acute spinal cord injury, the Reference Comparator for this study will be the Trunk Control Test (TCT)
Control group
Active

Outcomes
Primary outcome [1] 332143 0
Function in Sitting Test for people with SCI (FIST-SCI) Inter-rater reliability
Timepoint [1] 332143 0
FIST-SCI Assessments required for Inter-rater Reliability calculation: Rater A1, Rater B, Rater C

Rater assessments will occur within 10 days from the initial assessment
Primary outcome [2] 332144 0
Modified Function in Sitting Test (mFIST) Inter-rater reliability
Timepoint [2] 332144 0
mFIST Assessments required for Inter-rater Reliability calculation: Rater A1, Rater B, Rater C

Rater assessments will occur within 10 days from the initial assessment
Primary outcome [3] 332145 0
Trunk Control Test (TCT) Inter-rater Reliability
Timepoint [3] 332145 0
TCT Assessments required for Inter-rater Reliability calculation: Rater A1, Rater B, Rater C

Rater assessments will occur within 10 days from the initial assessment
Secondary outcome [1] 412343 0
FIST-SCI Intra-rater reliability
Timepoint [1] 412343 0
FIST-SCI Assessments required for Intra-rater Reliability calculation: Rater A1, Rater A2

Rater assessments will occur within 10 days from the initial assessment but not on the same day
Secondary outcome [2] 414133 0
mFIST Intra-rater Reliability
Timepoint [2] 414133 0
mFIST Assessments required for Inter-rater Reliability calculation: Rater A1, Rater A2

Rater assessments will occur within 10 days from the initial assessment but not on the same day
Secondary outcome [3] 414134 0
TCT Intra-rater Reliability
Timepoint [3] 414134 0
TCT Assessments required for Inter-rater Reliability calculation: Rater A1, Rater A2

Rater assessments will occur within 10 days from the initial assessment but not on the same day
Secondary outcome [4] 414135 0
Concurrent Validity: Spearman Correlation of SCIM vs FIST-SCI
Timepoint [4] 414135 0
Median FIST-SCI assessment score from Rater A1, B, and C correlated with the initial SCIM assessment.

The SCIM will be assessed on enrollment of the participant and the FIST-SCI Median will be taken from the scores of the assessments by RatersA1, B, and C within 10 days
Secondary outcome [5] 414136 0
Concurrent Validity: Spearman Correlation of SCIM vs mFIST
Timepoint [5] 414136 0
Median mFIST assessment score from Rater A1, B, and C correlated with the initial SCIM assessment.

The SCIM will be assessed on enrollment of the participant and the mFIST Median will be taken from the scores of the assessments by RatersA1, B, and C within 10 days
Secondary outcome [6] 414137 0
Concurrent Validity: Spearman Correlation of SCIM vs TCT
Timepoint [6] 414137 0
Median TCT assessment score from Rater A1, B, and C correlated with the initial SCIM assessment.

The SCIM will be assessed on enrollment of the participant and the TCT Median will be taken from the scores of the assessments by RatersA1, B, and C within 10 days
Secondary outcome [7] 414138 0
Convergent validity: Spearman Correlation of TCT and FIST-SCI
Timepoint [7] 414138 0
Median FIST-SCI assessment score from Rater A1, B, and C correlated with the median TCT assessment score from Rater A1, B, and C.

The TCT, mFIST, and FIST-SCI are always completed in the same session and are tested on on 4 occasions by three raters (Rater A, Rater B, Rater C) for the assessments A1, A2, B, and C. Only assessments A1, B, and C are used in this calculation
Secondary outcome [8] 414139 0
Convergent validity: Spearman Correlation of TCT and mFIST
Timepoint [8] 414139 0
Median mFIST assessment score from Rater A1, B, and C correlated with the median TCT assessment score from Rater A1, B, and C.

The TCT, mFIST, and FIST-SCI are always completed in the same session and are tested on on 4 occasions by three raters (Rater A, Rater B, Rater C) for the assessments A1, A2, B, and C. Only assessments A1, B, and C are used in this calculation
Secondary outcome [9] 414140 0
FIST-SCI ROC Analysis: to determine the sensitivity and specificity of a cutoff score to distinguish between individuals who require assistance to transfer and those who transfer independently or without external hands on assistance.

Transfer ability will be determined when the participant transfers to the mat table to perform the assessments in the first assessment session
Timepoint [9] 414140 0
Median FIST-SCI assessment score from Rater A1, B, and C and nominal data about transfer ability independence

The median FIST-SCI score will be taken from the scores of the assessments by RatersA1, B, and C within 10 days
Secondary outcome [10] 414141 0
mFIST ROC Analysis: to determine the sensitivity and specificity of a cutoff score to distinguish between individuals who require assistance to transfer and those who transfer independently or without external hands on assistance

Transfer ability will be determined when the participant transfers to the mat table to perform the assessments in the first assessment session
Timepoint [10] 414141 0
Median mFIST assessment score from Rater A1, B, and C and nominal data about transfer ability independence

The median mFIST score will be taken from the scores of the assessments by RatersA1, B, and C within 10 days
Secondary outcome [11] 414142 0
TCT ROC Analysis: to determine the sensitivity and specificity of a cutoff score to distinguish between individuals who require assistance to transfer and those who transfer independently or without external hands on assistance

Transfer ability will be determined when the participant transfers to the mat table to perform the assessments in the first assessment session
Timepoint [11] 414142 0
Median TCT assessment score from Rater A1, B, and C and nominal data about transfer ability independence

The median TCT score will be taken from the scores of the assessments by RatersA1, B, and C within 10 days
Secondary outcome [12] 414145 0
FSIT-SCI Responsiveness
Timepoint [12] 414145 0
Mean change of the FIST-SCI from Rater A1 (initial 10 days) to Rater A3 (6 week follow-up)
Secondary outcome [13] 414146 0
mFIST Responsiveness
Timepoint [13] 414146 0
Mean change of the mFIST from Rater A1 (initial 10 days) to Rater A3 (6 week follow-up)
Secondary outcome [14] 414147 0
TCT Responsiveness
Timepoint [14] 414147 0
Mean change of the TCT from Rater A1 (initial 10 days) to Rater A3 (6 week follow-up)

Eligibility
Key inclusion criteria
- Spinal cord injured at least 18 years of age
- Able to provide informed consent
- Traumatic or non-traumatic SCI of at least two weeks duration
- Cleared to sit out of bed
- Primary wheelchair-user
- Level and completeness of injury as follows:
o any SCI levels between cervical one (C1) and lumbar two (L2) if injury is motor incomplete (AIS C and D),
OR
o between cervical six (C6) and lumbar two (L2) if injury is motor complete (AIS A and B) according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosis of primary neurological injury other than SCI
- Untreated severe spasticity
- Current pressure ulcer in trunk, pelvic area or hips
- Unable to properly comprehend the protocol or study procedures
- Any medical conditions that prevent sitting for testing procedures
- Inability to achieve a short-sitting position.
- Unstable angina or orthostatic hypotension
- Any other medical or cognitive issues that the investigators think would significantly impact ones balance

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Intraclass correlation coefficients (ICC), using the coefficient alpha, will be used to analyze test-retest reliability and intra- and inter-rater reliabilities for the FIST-SCI, mFIST, and TCT in the inpatient sample and for the mFIST in the community dwelling sample. Spearman rank correlation coefficients of the FIST-SCI, mFIST, and TCT to the SCIM and BBS will be performed to assess correlations for validity in the inpatient sample and just the relationships with the mFIST will be analysed in the community dewlling sample. Bland Altman tests will also be used to verify validity in both samples. Anything with a coefficient of 0.78 to 0.89 will be deemed of good quality and anything higher than a .90 of excellent quality. We will also calculate overall means and standard deviations for each balance tests.

The most clinically applicable outcome measure for the inpatient setting will be identified based on the above analyses and a Receiver Operator Curve analysis determining the sensitivity and specificity of the ability of a cutoff score to distinguish between individuals who require assistance for transfers and those who are able to transfer independently.

We will report the change from the initial assessment to the 6-week follow-up assessment for the FIST-SCI, mFIST, and TCT. The standard error of the measure (SEM) and minimal detectable change (MDC) will be calculated for the most clinically applicable tool using the inter-rater ICCs based on the following formulas:

SEMinter-rater = SD (Average Outcome score ) x v1-ICC(2,k) (Inter-rater)
95% Confidence MDC= 1.96Z-score for 95% confidence x SEMinter-rater x v2

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/03/2023
Actual
Date of last participant enrolment
Anticipated
15/12/2023
Actual
Date of last data collection
Anticipated
26/01/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23220 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 38587 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 311937 0
Hospital
Name [1] 311937 0
Prince of Wales Hospital
Country [1] 311937 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
139 Barker St
Randwick, NSW, 2031
Country
Australia
Secondary sponsor category [1] 313856 0
None
Name [1] 313856 0
Address [1] 313856 0
Country [1] 313856 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311370 0
South Eastern Sydney Local Health District HREC via the Research Ethics and Governance Information System (REGIS)
Ethics committee address [1] 311370 0
Ethics committee country [1] 311370 0
Australia
Date submitted for ethics approval [1] 311370 0
Approval date [1] 311370 0
15/08/2022
Ethics approval number [1] 311370 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120862 0
Dr Claire Boswell-Ruys
Address 120862 0
Neuroscience Research Australia
139 Barker St
Randwick, NSW, 2031
Country 120862 0
Australia
Phone 120862 0
+610293391877
Fax 120862 0
Email 120862 0
[email protected]
Contact person for public queries
Name 120863 0
Annie Palermo
Address 120863 0
Neuroscience Research Australia
139 Barker St
Randwick, NSW, 2031
Country 120863 0
Australia
Phone 120863 0
+61 02 9399 1827
Fax 120863 0
Email 120863 0
[email protected]
Contact person for scientific queries
Name 120864 0
Annie Palermo
Address 120864 0
Neuroscience Research Australia
139 Barker St
Randwick, NSW, 2031
Country 120864 0
Australia
Phone 120864 0
+61 02 9399 1827
Fax 120864 0
Email 120864 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified participant data of published results will be shared
When will data be available (start and end dates)?
The data will be available upon request after completion of the trial with no end date
Available to whom?
The data will be available to researchers upon reasonable request
Available for what types of analyses?
Secondary analyses
How or where can data be obtained?
The data may be obtained by reasonable request from either the PI ([email protected]) or the project manager ([email protected])


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.