Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000221752
Ethics application status
Approved
Date submitted
5/02/2022
Date registered
8/02/2022
Date last updated
7/04/2024
Date data sharing statement initially provided
8/02/2022
Date results information initially provided
7/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Shear Wave Elastography to Assess the Change in Stiffness of Muscles in the Acute Stage Post-Stroke
Scientific title
Shear Wave Elastography to Assess the Change in Stiffness of Muscles in the Acute Stage Post-Stroke
Secondary ID [1] 306140 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle Stiffness 324834 0
Stroke 325169 0
Condition category
Condition code
Stroke 322274 322274 0 0
Haemorrhagic
Stroke 322275 322275 0 0
Ischaemic
Musculoskeletal 322575 322575 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
The condition being observed is the change in muscle stiffness that may occur as a result of a stroke.
The exposure is the Shear Wave Elastography assessment of the muscle stiffness. This is an advanced ultrasound technology that quantitatively determines the stiffness of tissue.
The transducer is placed lightly on the skin at the appropriate level and a measurement is taken. This will be done at three levels, on both arms, with the elbow fully extended and again with the elbow partially bent.

The Shear Wave Elastography assessment will take place twice a week, for the first four weeks after a stroke. Each scanning assessment takes approximately 1 hour. This will be performed by an accredited Senior Sonographer with experience in Shear Wave Elastography.

There will be Aquasonic Gel to facilitate the ultrasound transmission.
There will be paper towel to remove the gel.
There will be a measuring tape and skin-safe marker to mark the correct locations.

Each scanning session will be recorded in the participants hospital chart
Intervention code [1] 322547 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330036 0
Mean Shear Wave Velocity of biceps muscle by Shear Wave Elastography on a Canon Aplio i600 (Japan) with a 14-5 linear transducer.
Timepoint [1] 330036 0
Measured twice a week for four weeks after a stroke
Primary outcome [2] 330037 0
Change in cross-sectional area of biceps muscle (cm squared). Measured by standard ultrasound.
Timepoint [2] 330037 0
Measured twice a week for four weeks after a stroke
Secondary outcome [1] 404693 0
Spasticity assessment using Tardieu Scale by Occupational Therapists or Physiotherapists
Timepoint [1] 404693 0
Measured twice a week for four weeks after a stroke

Eligibility
Key inclusion criteria
Recent stroke with admission to Sunshine Coast University Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous strokes on the contralateral side.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Using data from comparable research, an alpha value of 0.05 and power of 80%, a minimum sample size of 6 participants is required. While this is the minimum number, this project aims to recruit and collect data on at least 36 participants in the data collection period (approximately 40 weeks). As it is not known which participants will go on to develop a change in muscle stiffness, a convenience sample of every eligible patient will be approached for recruited.
Statistical analysis will be descriptive, inferential and exploratory. The exploratory analysis is to assist in getting insights on the patterns over time.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/04/2023
Actual
25/05/2023
Date of last participant enrolment
Anticipated
1/01/2024
Actual
14/02/2024
Date of last data collection
Anticipated
29/01/2024
Actual
19/03/2024
Sample size
Target
36
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21436 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 36338 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 310713 0
University
Name [1] 310713 0
Queensland University of Technology
Country [1] 310713 0
Australia
Funding source category [2] 311710 0
Charities/Societies/Foundations
Name [2] 311710 0
Australasian Sonographers Association
Country [2] 311710 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
2 George St,
Brisbane City
QLD 4000
Country
Australia
Secondary sponsor category [1] 311932 0
None
Name [1] 311932 0
None
Address [1] 311932 0
None
Country [1] 311932 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310113 0
Prince Charles Hospital Ethics Committee
Ethics committee address [1] 310113 0
Research, Ethics and Governance Unit
Building 14
The Prince Charles Hospital
Rode Road, Chermside, Qld 4032
Ethics committee country [1] 310113 0
Australia
Date submitted for ethics approval [1] 310113 0
10/02/2022
Approval date [1] 310113 0
16/03/2022
Ethics approval number [1] 310113 0
75598
Ethics committee name [2] 310114 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [2] 310114 0
2 George St,
Brisbane City,
QLD 4000
Ethics committee country [2] 310114 0
Australia
Date submitted for ethics approval [2] 310114 0
22/03/2022
Approval date [2] 310114 0
20/03/2023
Ethics approval number [2] 310114 0

Summary
Brief summary
This project uses an advanced ultrasound technique called Shear Wave Elastography to assess the stiffness of muscles in stroke survivors. Shear Wave Elastography can determine the stiffness of tissue by measuring the Shear Wave Velocity, with stiffer tissues returning a higher velocity. After a stroke, the muscles may develop an increased stiffness which is typically assessed clinically, however SWE will be able to detect small changes more accurately and reliably than the current clinical assessment. This prospective cohort project aims to measure stiffness during the first four weeks after a stroke as the stiffness develops. A qualified Sonographer will perform the scans bedside at Sunshine Coast University Hospital. Stroke survivors will have their biceps muscle and biceps tendon scanned twice a week, for the first four weeks after their stroke. Both the affected and non-affected side will be assessed, with the elbow in both full extension, and 30 degrees flexion. It is hypothesised that as the participants stiffness develops the recorded Shear Wave velocities will increase and will correlate with the clinical assessments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116522 0
Miss Jacqueline Roots
Address 116522 0
Queensland University of Technology
Gardens Point Campus
2 George St
Brisbane City,
QLD 4000
Country 116522 0
Australia
Phone 116522 0
+61 07 31381373
Fax 116522 0
Email 116522 0
jacqueline.roots@hdr.qut.edu.au
Contact person for public queries
Name 116523 0
Miss Jacqueline Roots
Address 116523 0
Queensland University of Technology
Gardens Point Campus
2 George St
Brisbane City,
QLD 4000
Country 116523 0
Australia
Phone 116523 0
+61 07 31381373
Fax 116523 0
Email 116523 0
jacqueline.roots@hdr.qut.edu.au
Contact person for scientific queries
Name 116524 0
Miss Jacqueline Roots
Address 116524 0
Queensland University of Technology
Gardens Point Campus
2 George St
Brisbane City,
QLD 4000
Country 116524 0
Australia
Phone 116524 0
+61 07 31381373
Fax 116524 0
Email 116524 0
jacqueline.roots@hdr.qut.edu.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?
Datasets collected during the trial after de-identification.
When will data be available (start and end dates)?
Data will be available beginning immediately after publication. No end date determined.
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Meta-analysis.
How or where can data be obtained?
Principal Investigator jacqueline.roots@hdr.qut.edu.au


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.