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Trial registered on ANZCTR


Registration number
ACTRN12616001559404
Ethics application status
Approved
Date submitted
27/10/2016
Date registered
11/11/2016
Date last updated
15/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility, reliability and validity of using a biofeedback device (‘Archie’) to measure dynamic foot muscle strength
Scientific title
Feasibility, reliability and validity of using a biofeedback device (‘Archie’) to measure dynamic foot muscle strength in adults with or without foot problems associated with weak feet
Secondary ID [1] 290225 0
Protocol number X16 – 0395
Universal Trial Number (UTN)
U1111-1188-0560
Trial acronym
FReArchie
Linked study record

Health condition
Health condition(s) or problem(s) studied:
People with a health condition or problems associated with weak foot muscles 300483 0
Condition category
Condition code
Inflammatory and Immune System 300339 300339 0 0
Rheumatoid arthritis
Metabolic and Endocrine 300340 300340 0 0
Diabetes
Musculoskeletal 300341 300341 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Foot exercises with Archie biofeedback device

Materials: The Archie is a device that has been developed to assist with practicing foot exercises. Archie device is a small platform with 3 peripheral sensors and a mid foot sensor. Data is sent from the foot sensors to a computer with a visual display of the foot placement and mid foot movement to provide feedback of the foot activity.

Procedures: Over the course of one day, the Archie device will be tested for intra-rater, test re-test reliability of measuring foot arch movement, The device's output measures will be compared to other measures of foot strength or muscle size to determine its validity. The feasibility of completing the foot exercise tasks while using the device will be ascertained by survey.

The intervention is a series of four foot exercise tasks: speed of foot arch lift and relax, gradual concentric arch lift, gradual eccentric arch lowering and endurance of arch lift. The participants will be directed to attempt each exercise task three consecutive times over a period of 20 minutes. Participants will repeat the four exercise tasks three times during the course of the three hour lab attendance,with a 40 minute rest between the three testing sessions.

The first survey will be completed after the second practice of the exercise tasks using the sensor component of the device, with the participant blinded to feedback from the screen. The second survey will be completed after the third practice of the exercise tasks with the additional use of the biofeedback screen.

The intervention will be delivered by one of the investigators who has developed the device and the foot tasks, who has research experience of a minimum of 10 years. The mode of delivery will be face to face and will be provided individually.
Intervention code [1] 296056 0
Treatment: Devices
Comparator / control treatment
Comparators to ascertain the validity of Archie device:
Foot muscle strength determined by maximum toe flexion force in standing measured with a pressure platform
Foot muscle size determined by calculating the scanned cross-sectional area of extensor digitorum brevis, abductor hallucis and flexor hallucis brevis muscles measured with Real-time Ultrasound
Control group
Active

Outcomes
Primary outcome [1] 299806 0
Test re-test reliability of Archie device will be determined by the Archie device change in pressure, as reported by Archie output on the biofeedback screen
Timepoint [1] 299806 0
Archie device change in pressure measures will be recorded during each of the three testing sessions completed on the same day
Primary outcome [2] 299807 0
The validity of the Archie device, will be evaluated by comparing the devices' volumetric pressure measures with measures of muscle strength determined by toe flexor force using pedobarography,
Timepoint [2] 299807 0
Muscle force measures will be recorded during the second testing session completed on the same day
Primary outcome [3] 300003 0
Feasibility determined by two surveys designed for this study:
1) Foot Exercise Tasks Survey
2) Archie with Biofeedback Survey
Timepoint [3] 300003 0
The first survey will be completed after the second practice of the exercise tasks using the sensor component of the device, with the participant blinded to feedback from the screen. The second survey will be completed after the third practice of the exercise tasks with the additional use of the feedback screen.
Secondary outcome [1] 328183 0
Muscle size of the intrinsic foot muscles: extensor digitorum brevis, abductor hallucis and flexor hallucis brevis muscles will be assessed by calculating cross-sectional area via real time ultrasound scanning.
Timepoint [1] 328183 0
Measures of muscle size will be recorded during the second testing session completed on the same day.

Eligibility
Key inclusion criteria
Adults with or without foot problems or moderate foot deformities and who are able to walk a minimum of 50 meters unaided and are able to understand the information sheet and the consent form are able to take part in this study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People with neuromuscular diseases that severely reduce muscle strength; any acute or severe chronic foot pathologies and deformities; a history of previous foot ulcers or recent (in previous three months) foot or ankle surgery; cardiovascular conditions which are exacerbated by exercise; mental illness or who have practiced prescribed foot exercise in the previous three months.

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analysis of data will occur in SPSS version 22. Reliability will be assessed with intra-class correlation coefficients (3, 1). Validity will be assessed with Pearson’s or Spearman’s correlations, depending on data distribution, to evaluate any associations between the devices’ pressure measures and toe flexion force or muscle size. Feasibility will be explored with descriptive statistics and thematic qualitative analysis.

Recruitment
Recruitment status
Completed
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

Funding & Sponsors
Funding source category [1] 294631 0
University
Name [1] 294631 0
University of Sydney, Departmental funds
Address [1] 294631 0
University of Sydney
Cumberland Campus
Faculty of Health Sciences
75 East St
Lidcombe,
NSW 2141
Country [1] 294631 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney
Level 2 Margaret Telfer Building
NSW 2006
Country
Australia
Secondary sponsor category [1] 293495 0
None
Name [1] 293495 0
Address [1] 293495 0
Country [1] 293495 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296072 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 296072 0
Human Ethics Office
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 296072 0
Australia
Date submitted for ethics approval [1] 296072 0
15/09/2016
Approval date [1] 296072 0
23/01/2017
Ethics approval number [1] 296072 0
2016/881

Summary
Brief summary
This study examines the reliability, validity and feasibility of using Archie, a foot biofeedback device to determine if mid arch movement and foot exercise practice can be measured and monitored in those with a range of foot types or foot problems associated with weak feet. Various physical measures, questionnaires and surveys will be collected from participants over the course of one day. The results of this study will be used to prepare for future randomised controlled trials on foot exercise for the treatment of a range of foot problems associated with weak feet.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69294 0
Ms Penelope Latey
Address 69294 0
University of Sydney
Cumberland Campus
75 East Street
Lidcombe,
N.S.W 2141
Country 69294 0
Australia
Phone 69294 0
+61 2 93519017
Fax 69294 0
Email 69294 0
plat6993@uni.sydney.edu.au
Contact person for public queries
Name 69295 0
Ms Penelope Latey
Address 69295 0
University of Sydney
Cumberland Campus
75 East street
Lidcombe.
N.S.W 2141
Country 69295 0
Australia
Phone 69295 0
+61 2 93519017
Fax 69295 0
Email 69295 0
plat6993@uni.sydney.edu.au
Contact person for scientific queries
Name 69296 0
Ms Penelope Latey
Address 69296 0
University of Sydney
Cumberland Campus
75 East Street
Lidcombe.
N.S.W 2141
Country 69296 0
Australia
Phone 69296 0
+61 2 93519017
Fax 69296 0
Email 69296 0
plat6993@uni.sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary