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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]

RSH4955

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

heel pain

flat feet

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Musculoskeletal

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]

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]

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]

Measured at each walking trial at the single visit

Secondary outcome [1]

comfort score measured on a 100mm comfort scale

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4701 - North Rockhampton

Funding & Sponsors

Funding source category [1]

University

Name [1]

Central Queensland University

Address [1]

Central Queensland University;
554-700 Yaamba Rd, Norman Gardens
Rockhampton QLD 4701

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

CQ University's Human Research Ethics Committee

Ethics committee address [1]

Central Queensland University; 
554-700 Yaamba Rd, Norman Gardens QLD.
Rockhampton QLD 4701

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/01/2019

Approval date [1]

15/02/2019

Ethics approval number [1]

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

Dr Malia Ho

Address

Central Queensland University;
554-700 Yaamba Rd, Norman Gardens QLD.
Rockhampton QLD 4701

Country

Australia

Phone

+61 7 4930 9469

Fax

m.ho@cqu.edu.au

Contact person for public queries

Name

Malia Ho

Address

Central Queensland University;
554-700 Yaamba Rd, Norman Gardens QLD.
Rockhampton QLD 4701

Country

Australia

Phone

+61 7 4930 9469

Fax

m.ho@cqu.edu.au

Contact person for scientific queries

Name

Malia Ho

Address

Central Queensland University;
554-700 Yaamba Rd, Norman Gardens QLD.
Rockhampton QLD 4701

Country

Australia

Phone

+61 7 4930 9469

Fax

m.ho@cqu.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?

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 (m.ho@cqu.edu.au)

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
5227	Study results article	Yes	https://doi.org/doi: 10.1097/PXR.0000000000000068

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The biomechanical effects of 3D printed and traditionally made foot orthoses in individuals with unilateral plantar fasciopathy and flat feet.	2022	https://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.

Trial Review

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Documents added manually

Documents added automatically