Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000265673p
Ethics application status
Submitted, not yet approved
Date submitted
29/01/2023
Date registered
13/03/2023
Date last updated
13/03/2023
Date data sharing statement initially provided
13/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Foot muscle measures of strength and cross-sectional area by ultrasound in the diabetic population.
Scientific title
Foot muscle measures of strength and cross-sectional area by ultrasound in the diabetic population.

Secondary ID [1] 308819 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic peripheral neuropathy
328815 0
Diabetic foot changes 328816 0
Intrinsic foot muscle atrophy 328817 0
Intrinsic foot muscle weakness 328818 0
Condition category
Condition code
Metabolic and Endocrine 325823 325823 0 0
Diabetes
Musculoskeletal 325824 325824 0 0
Other muscular and skeletal disorders
Neurological 325982 325982 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Name
Ultrasound (US) examination of the Intrinsic Foot Muscles (IFM)
Biofeedback device assessment of the IFM using ‘Archercise’

Why
Diabetic Peripheral Neuropathy (DPN) is a prevalent and debilitating condition. One way of detecting and managing DPN is through the assessment of the Intrinsic Foot Muscles (IFM). Ultrasound (US) has been used to detect IFM muscular atrophy in DPN patients. US is an inexpensive, efficient, and safer imaging modality compared to other such as Computed Tomography (CT) and Magnetic Resonance Imaging (MRI). US can also be used as a biofeedback tool for assessing and improving muscular activation when using real-time functions. In addition, exercise has been found to be beneficial in delaying the usual course of DPN, skin damage and ulceration. However, diabetic patients have lower physical activity rates due to limitations such as difficult access to therapy, poor compliance, and limited support to maintain exercise therapy. Therefore, this study aims to assess whether a newly developed biofeedback device, ‘Archercise’ – a foot muscle exercise and strengthening tool, can correlate IFM Cross-Sectional Area (CSA) measured by US with foot arch control and performance. From this, IFM muscular and functional changes can potentially be detected earlier. In addition IFM strength and control can be monitored and improved


What

Materials

Consent form and Participant Information Statement
All participants will receive an ethics approved consent form so that the potential participants have an adequate understanding of the proposed research and the implications of participations.

A participant information statement will be provided that outlines in clear and simple terms the purpose of the research and how participants will be involved.

Both these forms will be printed and handed to the participants or send electronically via email if the participant requests.

Pre-study questionnaire
Participants with answer and pre-study questionnaire via a REDCAP survey. The questions involved are:

- Age
- Sex
- Weight
- Body Mass Index (BMI)
- Duration of Diabetes
- Presence of Neuropathic Symptoms using Michigan Neuropathy Screening Instrument

Foot Morphology Measures
A digital height gauge with a carbide scribe will be used to measure dorsal arch height. An embedded platform will be used to measure full-foot length.

Ultrasound Machine
A Philips IU22 ultrasound system (Philips Healthcare Solutions, Bothell, WA, USA) with a 12-5 MHz linear array transducer will be used

Archercise Device
'Archercise' (patent pending PCT/AU2016/050437) will be connected to a graphical user interface (GUI) based computer program to control the sensor footplate, receiving, displaying and saving sensor data in real-time.

Information on these materials will be provided in an online appendix of the research paper

Procedures

Foot Morphology Measures
1) Dominant foot will be determined by which foot is used to step up onto a platform and kick a ball
2) Dorsal arch height will be measured both sitting and standing using a digital height gauge
3) Full foot length: participants will be seated with their ankles, knees and hips at 90 degrees with feet placed on an embedded platform to measure from mid-heel to longest toe tip

Ultrasound Assessment

The participant will have their US examination completed directly after answering their questionnaire

A Philips IU22 ultrasound system (Philips Healthcare Solutions, Bothell, WA, USA) with a 12-5 MHz linear array transducer will be used on the dominant foot of the participant. Each participant will be allocated a coded number to be deidentified on data. Two intrinsic foot muscles Abductor Hallucis (AbH) and Extensor Digitorum Brevis (EDB) cross-sectional areas will be evaluated in both the longitudinal and transverse planes.

Participants will be seated on a raised examination table with their leg relaxed and knee flexed 90 degrees. Assistance will be provided with any movements on and off the table, and participants will be informed when the electronic table will move to prevent discomfort and falls. Pillows will also be provided on the table for comfort and stability. The participant's foot will be stabilised on the researcher's lap, with the ankle relaxed and the plantar aspect of the foot facing towards the ground. Appropriate bony anatomy will be palpated to identify the correct location of the intrinsic foot muscles of interest, such as the navicular tubercle and the medial sesamoid bone. Ultrasound gel is placed between the transducer and the foot to remove air artefacts and ensure good contact with the anatomy.

Once the thickest part of the muscle is identified, the transducer will be rotated at 90 degrees at 50% of the transducer length perpendicularly to the muscle to capture its maximal cross-sectional area. The cross-sectional area will then be determined using the manual trace tool function of the ultrasound system around the circumference of the muscle cross-section. Finally, the thickness will be measured using the calliper function. Repeated measurements at the exact location will be taken to ensure the accuracy and reliability of measures.

Biofeedback Device Assessment

Participants will then be moved to the Biofeedback device assessment station directly after their US examination

'Archercise' (patent pending PCT/AU2016/050437) will be connected to a graphical user interface (GUI) based computer program to control the sensor footplate, receiving, displaying, and saving sensor data in real-time. This will be used to determine intrinsic foot muscle performance and surrogate measures of strength. The testing procedures will use a previously developed protocol (Latey, 2018).
Latey, P. (2018). Measuring and managing foot muscle weakness. Retrieved from http://hdl.handle.net/2123/19174 Available from The University of Sydney Sydney eScholarship database.


Participants will be seated with knees flexed 90 degrees, double leg stance. The dominant foot will be placed on the biofeedback device with toes and heels on the appropriate sensors and the foot's arch supported under the device's bladder.

The bladder of the device will be inflated under the arch, and the participants will be asked to maintain contact with the toe and heel pressure sensors while performing the arch exercises to the best of their ability.

Four exercises will be undertaken. Data capture and exercise sequence will be 10 seconds preparation, 10 seconds test time and 10 seconds end (total 30 seconds). The endurance arch lift sequences will involve 10 seconds preparation, 60 seconds test time and 20 seconds end (total 90 seconds)

1. Speed: Sequential isotonic muscle contractions to elevate and lower the arch in as large a range as possible and as quickly as possible.
2. Arch Elevation: Gradual isotonic concentric contraction of the foot arch muscle to lift the arch as high as possible
3. Arch Lowering: Pre-test arch elevation, then a gradual isotonic eccentric contraction of the foot arch muscle to lower the arch.
4. Endurance: Elevate the arch and maintain that controlled elevation in an isometric contraction of the foot and arch muscles.

Participants will visualise the data continuously during the exercises, with data points depending on their performance.


Who provided
Sonographer 20+ years experience
Physiotherapist and Pilates Instructor 20+ years experience
Diagnostic Radiographer + medical student 6+ years experience

When and how much
The intervention will be delivered over one session. This session will take approximately one hour to complete all components.
Where
Ultrasound Lab at The University of Sydney Where the Ultrasound Machine and Archercise Biofeedback device will be kept and used.

Tailoring
N/A

Modifications
N/A

How Well
N/A
Intervention code [1] 325292 0
Early detection / Screening
Comparator / control treatment
Age-matched control group of healthy adults. These participants will be recruited with the research participants.
Selection critera:
Aged 18-75
No significant medical conditions
English speaking language
Control group
Active

Outcomes
Primary outcome [1] 333665 0
The cross-sectional thickness of the Abductor Hallucis assessed when using an ultrasound
Timepoint [1] 333665 0
Ultrasound completed immediately after completing the questionnaire and having foot morphology measurements on testing day
Primary outcome [2] 333666 0
The cross-sectional thickness of the Extensor Digitorum brevis muscle assessed when using an ultrasound
Timepoint [2] 333666 0
Ultrasound completed immediately after completing the questionnaire and having foot morphology measurements on testing day
Primary outcome [3] 333964 0
Measurement of Intrinsic foot muscle control using Archerscise Biofeedback device.
Timepoint [3] 333964 0
Immediately after Ultrasound Examination on testing day
Secondary outcome [1] 418868 0
Measurement of Intrinsic foot muscle speed using Archerscise Biofeedback device.
Timepoint [1] 418868 0
Immediately after Ultrasound Examination on testing day
Secondary outcome [2] 418869 0
Measurement of Intrinsic foot muscle endurance using Archerscise Biofeedback device.
Timepoint [2] 418869 0
Immediately after Ultrasound Examination on testing day

Eligibility
Key inclusion criteria
Adults between the age of 18-75 years
Currently diagnosed with Type 2 Diabetes Mellitus
Can be experiencing neuropathic or no neuropathic symptoms

Inclusion criteria control
Adults between the age of 18-75 years
No significant medical conditions
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Major neurological conditions such as stroke, multiple sclerosis, spinal lesions and cognitive impairments.
English language and reading capability below being able to understand the participant information statement.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Previous studies of a similar design used 21 participants and 35 participants. Therefore, to generate appropriate power and significance of the study, while considering our time constraints, a sample of 25 non-randomised participants who meet the inclusion criteria will be appropriate and feasible. An age-matched control group will also be included in the study.

Statistical analysis will be conducted using SPSS for Windows v22.0 (IBM SPSS Inc., Chicago, IL). Descriptive statistics will be calculated for patient characteristics (gender, age, height, weight, body mass index, type and duration of diabetes, presence of neuropathic symptoms, and morphology measures of foot length and dorsal arch height of the dominant foot). The intra-rater and inter-rater reliability of the variables will be assessed with intraclass correlation coefficients. The levels of reliability will be classed, from <0.40 poor, >0.4 to <0.75 fair to good, >0.75 excellent. Data will be analysed for normalcy with the Kolmogorov-Smirnov and Shapiro-Wilk tests. Variables found to have moderate to good ICCs will be analysed to determine any association between the ultrasound measures, measures of toe flexion force, foot performance scores on the Archercise biofeedback device and patient characteristics using Pearson's correlation coefficient.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/04/2023
Actual
Date of last participant enrolment
Anticipated
30/09/2023
Actual
Date of last data collection
Anticipated
30/10/2023
Actual
Sample size
Target
21
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313042 0
Self funded/Unfunded
Name [1] 313042 0
N/A
Country [1] 313042 0
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 314727 0
University
Name [1] 314727 0
The University of Sydney
Address [1] 314727 0
128-140 Broadway, Chippendale NSW 2007
Country [1] 314727 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312295 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 312295 0
Ethics committee country [1] 312295 0
Australia
Date submitted for ethics approval [1] 312295 0
13/09/2022
Approval date [1] 312295 0
Ethics approval number [1] 312295 0

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

Contacts
Principal investigator
Name 124146 0
Ms Tiffany Hanna
Address 124146 0
Susan Wakil Health Building, The University of Sydney
Western Ave, Camperdown NSW 2050
Country 124146 0
Australia
Phone 124146 0
+61 0448801209
Fax 124146 0
Email 124146 0
[email protected]
Contact person for public queries
Name 124147 0
Jillian Clarke
Address 124147 0
Susan Wakil Health Building
The University of Sydney
Western Ave, Camperdown, NSW, 2050
Country 124147 0
Australia
Phone 124147 0
+61 0416110260
Fax 124147 0
Email 124147 0
[email protected]
Contact person for scientific queries
Name 124148 0
Jillian Clarke
Address 124148 0
Susan Wakil Health Building
The University of Sydney
Western Ave, Camperdown, NSW, 2050
Country 124148 0
Australia
Phone 124148 0
+61 0416110260
Fax 124148 0
Email 124148 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not know at this point in time what the future use of the data will be, possibly for future Honours or PhD students. We will maintain standards of data protection by storing this in the RDS. We will seek ethical approval for any future secondary use of the data.
De-identified line by line data is not necessary for any future research projects


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18168Informed consent form    385272-(Uploaded-29-01-2023-18-48-45)-Study-related document.pdf



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.