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Trial registered on ANZCTR


Registration number
ACTRN12620000960954
Ethics application status
Approved
Date submitted
1/08/2020
Date registered
25/09/2020
Date last updated
25/09/2020
Date data sharing statement initially provided
25/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A step in the right direction - comparing 3D printed orthoses and traditional orthoses in individuals with flat feet.
Scientific title
A step in the right direction - comparing the effect 3D printed orthoses and traditional orthoses on the walking gait of individuals with flat feet.
Secondary ID [1] 301930 0
RSH4955
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heel pain 318449 0
flat feet 318450 0
Condition category
Condition code
Physical Medicine / Rehabilitation 316458 316458 0 0
Other physical medicine / rehabilitation
Musculoskeletal 316803 316803 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This preliminary study employs a within-subject single-blinded randomised crossover study design.
Fifteen flat footed adults with heel pain in one foot will be recruited. This sample size is the maximum number of recruitment allowed within the funding allocation. Participants will be recruited from the CQUniversity Health Clinic.
The inclusion criteria include: being over 18 years of age and having heel pain in one foot for more than 6 months. Exclusion criteria include having a BMI > 36 kgm2, any medical conditions affecting gait, skin allergies to double sided tape and adhesives.
An information sheet will be provided which will explain the risks and benefits of their participation. They will be given the opportunity ask questions and have them answered to their satisfaction. They will attend an initial assessment session at the CQUniversity Health Clinic which will take about 1 hour. The potential participants need to provide written informed consent before being assessed by podiatrists registered with the
Australian Health Practitioner Regulation Agency (AHPRA). Standard CQUniversity Health Clinic podiatry assessment forms will be used.
The podiatrist will assess the potential participant to ensure that they fit the inclusion criteria and that their heel pain is clinically suitable for orthotic therapy. Those individuals who are excluded will be referred to the appropriate health care professional for continued care. Those who fully meet the inclusion criteria will have their foot moulds taken by podiatrists [MH and JN] with 3D foot scanning and with plaster casting. Foot moulds will be sent to the same external orthotic laboratory which will use 3D printing techniques and traditional methods to fabricate two pairs of orthotic devices. The foot scans and casts will be coded in order to blind the orthotic laboratory as to the individual whom the orthoses is intended. This will reduce potential bias in the manufacture process.

When the two pairs of orthoses are ready, dimensions will be measured and compared. The same member of the research team will measure all the orthoses to ensure consistency in measurement.
The participant will attend a second session lasting approximately 2 hours at the CQUniversity biomechanics laboratory for data collection. Participant's height and mass will be recorded at the start of the session followed by a three-dimensional gait analysis. Reflective markers will be attached to the participants. The reflective markers are tracked by a special camera system (Vicon Motion Systems Ltd, Oxford, UK) which only collects the reflection of the markers. No standard video of the participant is collected. Participants will then be asked to complete a series of walking trials (minimum 10 trials per condition) over a 8m walkway during which time, lower limb and foot kinematics(i.e. joint angles) and kinetics (i.e. forces),will be collected using an 8-camera Vicon motion capture system (Vicon Motion Systems Ltd, Oxford, UK) synchronised with an AMTI force plate (Advanced Mechanical Technology, Inc., Watertown, Massachusetts). Participants will complete the gait analysis under the three conditions: (1) without orthoses (control),
(2) with the 3D printed orthoses, and (3) the traditionally made orthoses, in a randomised order. The order of conditions are determined by a random number software. The trials of the conditions will occur one after the other with a rest period of about 5 minutes in between trials. A standard canvas lace up shoe, modified with cut outs for the placement of reflective markers, will be supplied to the participant and used for the entire gait analysis.
Intervention code [1] 318215 0
Treatment: Devices
Comparator / control treatment
No foot orthoses
The participants will be wearing a standardised pair of canvas lace up sneakers provided to all participants, with the existing flat insole that comes with the shoe.
Control group
Active

Outcomes
Primary outcome [1] 324608 0
Composite outcomes for change in hip, knee, ankle and foot kinematics and kinetics. This will be assessed using an 8 camera Vicon motion capture system and AMTI forceplate.
Timepoint [1] 324608 0
Measured at each walking trial at the single visit
Secondary outcome [1] 385161 0
comfort score measured on a 100mm comfort scale
Timepoint [1] 385161 0
Measured at the end of each walking trial at the single visit.

Eligibility
Key inclusion criteria
Participants must have heel pain in one foot for more than 6 months,
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI of less than 36 kg/m2,
Skin allergies to double sided tape and adhesives
Currently using foot orthotic devices
pathological conditions affecting gait e.g. Parkinson's disease, Stroke etc

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Number of patients required (n=15) were limited by the research grant funds available to find the fabrication of 30 pairs of foot orthoses.
Paired t-tests and repeated measures analysis of variance (ANOVA) will be used to examine the differences in outcome variables between conditions. Statistical significance will be set at an alpha level of 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/12/2019
Date of last participant enrolment
Anticipated
2/11/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
15
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 30884 0
4701 - North Rockhampton

Funding & Sponsors
Funding source category [1] 306344 0
University
Name [1] 306344 0
Central Queensland University
Country [1] 306344 0
Australia
Primary sponsor type
University
Name
Central Queensland University
Address
Central Queensland University;
554-700 Yaamba Rd, Norman Gardens QLD.
Rockhampton QLD 4701
Country
Australia
Secondary sponsor category [1] 306848 0
None
Name [1] 306848 0
Address [1] 306848 0
Country [1] 306848 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306553 0
CQ University's Human Research Ethics Committee
Ethics committee address [1] 306553 0
Central Queensland University;
554-700 Yaamba Rd, Norman Gardens QLD.
Rockhampton QLD 4701
Ethics committee country [1] 306553 0
Australia
Date submitted for ethics approval [1] 306553 0
24/01/2019
Approval date [1] 306553 0
15/02/2019
Ethics approval number [1] 306553 0
21471

Summary
Brief summary
A foot orthosis is an insert worn inside shoes to help realign the foot and ankle to reduce excessive movements that lead to pain, stress, and strain in the lower limb during functional tasks. The traditional process of orthotic fabrication is time consuming and labour intensive with the quality and effectiveness of the final product largely dependent on the skill level of the podiatrist fabricating the device. The use of computer aided design and manufacture (3D printing) has the potential to reduce the time and cost of orthotic manufacture, and reduce dependence on podiatrist's skill. Despite the reported benefits of the technology driven foot orthoses, the efficacy of 3D printed orthoses in changing gait
kinematics, compared to traditionally made orthoses, has not been adequately investigated. This project will compare the immediate effects of traditionally manufactured orthoses and 3D printed orthoses in regards to: (1) manufacturing specifications (e.g. size and shape of the orthoses), (2) lower limb kinematics and kinetics, and (3) comfort levels in patients with clinically diagnosed heel pain. The results of this study will show how orthoses made using new technology compare with those made using traditional methods.
Paired t-tests and repeated measures analysis of variance (ANOVA) will be used to examine the differences in outcome measures between conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104266 0
Dr Malia Ho
Address 104266 0
Central Queensland University;
554-700 Yaamba Rd, Norman Gardens QLD.
Rockhampton QLD 4701
Country 104266 0
Australia
Phone 104266 0
+61 7 4930 9469
Fax 104266 0
Email 104266 0
[email protected]
Contact person for public queries
Name 104267 0
Malia Ho
Address 104267 0
Central Queensland University;
554-700 Yaamba Rd, Norman Gardens QLD.
Rockhampton QLD 4701
Country 104267 0
Australia
Phone 104267 0
+61 7 4930 9469
Fax 104267 0
Email 104267 0
[email protected]
Contact person for scientific queries
Name 104268 0
Malia Ho
Address 104268 0
Central Queensland University;
554-700 Yaamba Rd, Norman Gardens QLD.
Rockhampton QLD 4701
Country 104268 0
Australia
Phone 104268 0
+61 7 4930 9469
Fax 104268 0
Email 104268 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?
individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal, for IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Ho, M, Nguyen, J., Talbot, K., Heales, L., Kong, P... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe biomechanical effects of 3D printed and traditionally made foot orthoses in individuals with unilateral plantar fasciopathy and flat feet.2022https://dx.doi.org/10.1016/j.gaitpost.2022.06.006
N.B. These documents automatically identified may not have been verified by the study sponsor.