Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001015336
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
3/08/2026
Date registered
Help: Date registered
18/08/2026
Date last updated
Help: Date last updated
18/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
18/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Biomechanical effects of 3D-printed metamaterial foot orthoses with anti-pronatory graded stiffness on lower limb kinematics and kinetics in healthy adults: A within subjects immediate effects cross over study
Scientific title
Biomechanical effects of 3D-printed metamaterial foot orthoses with anti-pronatory graded stiffness on lower limb kinematics and kinetics in healthy adults: A within subjects immediate effects cross over study
Additional trial identifiers [1] 317886 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records
ACTRN12626000508370
ACTRN12625000905460
ACTRN12624001175561
These are related studies within the same research program, using similar study designs and the same manufacturing approach for 3D-printed foot orthoses, while investigating different research questions, clinical populations, intervention designs, and outcome measures.

Health condition
Health condition(s) studied:
Lower limb overuse injuries 342831 0
Plantar fasciopathy 342832 0
Tibialis posterior tendinopathy 343181 0
Achilles tendinopathy 343182 0
Medial tibial stress syndrome 343183 0
Patellofemoral pain syndrome 343184 0
Condition category
Condition code
Musculoskeletal 338947 338947 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 338948 338948 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 339263 339263 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Excessive or prolonged foot pronation is associated with lower limb overuse injuries. Foot orthoses incorporating anti-pronatory design features are frequently used to reduce excessive pronation and related tissue stresses. This study will examine the biomechanical effects of non-customised 3D-printed metamaterial orthoses incorporating antipronatory stiffness designs and compare with neutral orthoses and orthoses with typical antipronatory design features in healthy adults.

This study includes four interventional and two control arms. As a randomised cross-over study, each participant will experience each intervention and control arm.

Participants will be invited to attend one appointment. The appointment is anticipated to take approximately 90 minutes.

At the appointment, following screening for inclusion/exclusion criteria and provision of informed consent, participants will complete walking trials while wearing standardised footwear and orthotic conditions presented in a randomised order. During each condition, plantar pressures, lower-limb kinematics, and temporospatial gait parameters will be recorded. Rest periods will be provided between conditions to minimise fatigue.

Intervention arm 1: Ethylene-Vinyl Acetate (EVA) foam orthosis with medial heel skive. A prefabricated foot orthosis based on the insole from Comparator Arm 1, modified with a 4 mm medial heel skive. This represents a traditional anti-pronatory orthotic design commonly used in podiatric practice. This will be manufactured from EVA with medium hardness.

Intervention Arm 2: 3D-printed metamaterial insole with uniform stiffness. A 3D-printed metamaterial foot orthosis/insole with uniform stiffness across the device, equivalent to approximately medium EVA hardness. The geometry of this will be matched to that of Comparator Arm 1.

Intervention Arm 3: 3D-printed metamaterial insole with moderate medial stiffness gradient: a 3D-printed metamaterial foot orthosis/insole designed with high medial rearfoot stiffness and medium lateral rearfoot stiffness to provide an anti-pronatory graded stiffness pattern. The medial rearfoot region will be equivalent to EVA with high hardness, while the lateral rearfoot region will be equivalent EVA with medium hardness. The geometry of this will be matched to that of Comparator Arm 1.

Intervention Arm 4: 3D-printed metamaterial insole with high medial stiffness gradient: a 3D-printed metamaterial foot orthosis/insole designed with high medial rearfoot stiffness and low lateral rearfoot stiffness. The medial rearfoot region will be equivalent to EVA with high hardness, while the lateral rearfoot region will be equivalent EVA with low hardness. The geometry of this will be matched to that of Comparator Arm 1.


Each orthotic condition will be fitted to standardised footwear in a randomised order. Participants will be blinded to the orthotic condition being tested. Following a familiarisation period, participants will walk at a self-selected comfortable speed while in-shoe plantar pressures are recorded using the PEDAR-X system and lower-limb kinematics and temporospatial gait parameters are measured using the Zebris FDM-T gait analysis system. For each orthotic condition, at least twelve valid PEDAR steps and five Zebris gait cycles will be collected. Rest periods of 2 to 3 minutes will be provided between study arms to minimise fatigue.

As this is an immediate effects study, participants will not wear the orthoses outside the laboratory and no assessment of adherence will be performed. Should any intervention be discontinued before completion of testing (for example, due to discomfort reported by the participant), this will be recorded and reported.

All orthotic devices will be fitted by members of the research team at a QUT research laboratory, under the supervision of a registered podiatrist.
Intervention code [1] 334734 0
Treatment: Devices
Description of the comparator or control
Comparator arm 1: Neutral EVA foam orthosis: A prefabricated neutral foot orthosis with a generic contour but no further anti-pronatory design features. This condition will allow the biomechanical effects of the 3D-printed metamaterial and EVA orthoses with anti-pronatory design features to be compared against an unmodified standard orthotic condition. This will be manufactured from EVA with medium hardness.

Comparator arm 2: Standard shoe insole: The prefabricated insole that comes with the standardised shoe. This will act as the baseline comparator against which the 3D-printed metamaterial orthoses and the prefabricated anti-pronatory orthosis will be compared.
Control group
Active

Outcomes
Primary outcome [1] 346193 0
Regional in-shoe peak plantar pressure at rearfoot during walking.
Timepoint [1] 346193 0
Assessed during the single study visit under each orthotic condition immediately following a 2–3 minute acclimatisation period and approximately 1 minute of treadmill walking (primary timepoint: immediate effects during the testing session).
Primary outcome [2] 346194 0
Regional in-shoe pressure-time integral at rearfoot during walking.
Timepoint [2] 346194 0
Assessed during the single study visit under each orthotic condition immediately following a 2–3 minute acclimatisation period and approximately 1 minute of treadmill walking (primary timepoint: immediate effects during the testing session).
Primary outcome [3] 346497 0
Center of pressure progression
Timepoint [3] 346497 0
Assessed during the single study visit under each orthotic condition immediately following a 2–3 minute acclimatisation period and approximately 1 minute of treadmill walking (primary timepoint: immediate effects during the testing session).
Secondary outcome [1] 464956 0
Participant-reported insole comfort.
Timepoint [1] 464956 0
Immediately after each insole condition during the single study visit, and after completion of all insole conditions.
Secondary outcome [2] 464957 0
Regional in-shoe peak plantar pressure at midfoot during walking.
Timepoint [2] 464957 0
Assessed during the single study visit under each orthotic condition immediately following a 2–3 minute acclimatisation period and approximately 1 minute of treadmill walking (primary timepoint: immediate effects during the testing session).
Secondary outcome [3] 466122 0
Regional in-shoe pressure-time integral at midfoot during walking.
Timepoint [3] 466122 0
Assessed during the single study visit under each orthotic condition immediately following a 2–3 minute acclimatisation period and approximately 1 minute of treadmill walking (primary timepoint: immediate effects during the testing session).
Secondary outcome [4] 466123 0
Lower-limb muscle activation during walking - Tibialis Anterior
Timepoint [4] 466123 0
Assessed during the single study visit under each orthotic condition immediately following a 2–3 minute acclimatisation period and approximately 1 minute of treadmill walking (primary timepoint: immediate effects during the testing session).
Secondary outcome [5] 466124 0
Lower-limb muscle activation during walking - Soleus
Timepoint [5] 466124 0
Assessed during the single study visit under each orthotic condition immediately following a 2–3 minute acclimatisation period and approximately 1 minute of treadmill walking (primary timepoint: immediate effects during the testing session).
Secondary outcome [6] 466125 0
Lower-limb muscle activation during walking - Medial gastrocnemius
Timepoint [6] 466125 0
Assessed during the single study visit under each orthotic condition immediately following a 2–3 minute acclimatisation period and approximately 1 minute of treadmill walking (primary timepoint: immediate effects during the testing session).
Secondary outcome [7] 466126 0
Lower-limb muscle activation during walking - Peroneus Longus
Timepoint [7] 466126 0
Assessed during the single study visit under each orthotic condition immediately following a 2–3 minute acclimatisation period and approximately 1 minute of treadmill walking (primary timepoint: immediate effects during the testing session).
Secondary outcome [8] 466128 0
Regional external ground-reaction forces at rearfoot during walking.
Timepoint [8] 466128 0
Assessed during the single study visit under each orthotic condition immediately following a 2–3 minute acclimatisation period and approximately 1 minute of treadmill walking (primary timepoint: immediate effects during the testing session).
Secondary outcome [9] 466129 0
Regional external ground-reaction forces at midfoot during walking.
Timepoint [9] 466129 0
Assessed during the single study visit under each orthotic condition immediately following a 2–3 minute acclimatisation period and approximately 1 minute of treadmill walking (primary timepoint: immediate effects during the testing session).

Eligibility
Key inclusion criteria
Healthy adults aged 18 years and over.
Have no diagnosed systemic disorders that affect gait
Able to walk independently for at least 30 minutes without the use of walking aids
Wear standard shoe sizes compatible with the study footwear and orthoses
Able to understand and provide informed consent in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Peripheral neuropathy (loss of protective sensation)
Peripheral vascular disease
Lower limb amputation
Allergy to medical skin adhesives
History of falls in previous 12 months
Current foot, ankle, knee, or hip pain (4 weeks), or recent (6 month) trauma/surgery affecting gait

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)
All participants will experience all intervention arms in a randomised order in this immediate-effects crossover trial. Allocation of order of interventions is centrally randomised by computer prior to commencing participant recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
A target sample size of 20 participants was determined using an a priori paired-samples comparison based on the expected change in medial rearfoot peak plantar pressure reported by Bonanno et al. (2012). The calculation used an expected mean difference of 31.3 kPa, assumed correlation of 0.5, alpha of 0.05, and 80% power. This sample size is considered appropriate for the randomised within-subject crossover design, where each participant completes all orthotic conditions and acts as their own control.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/08/2026
Actual
Date of last participant enrolment
Anticipated
2/10/2026
Actual
Date of last data collection
Anticipated
2/10/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 46184 0
4059 - Kelvin Grove

Funding & Sponsors
Funding source category [1] 322426 0
University
Name [1] 322426 0
Queensland University of Technology
Country [1] 322426 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Country
Australia
Secondary sponsor category [1] 325358 0
None
Name [1] 325358 0
Address [1] 325358 0
Country [1] 325358 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320920 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [1] 320920 0
Ethics committee country [1] 320920 0
Australia
Date submitted for ethics approval [1] 320920 0
26/05/2026
Approval date [1] 320920 0
15/07/2026
Ethics approval number [1] 320920 0
10954

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

Contacts
Principal investigator
Name 152074 0
Mr Alexander Terrill
Address 152074 0
Queensland University of Technology, 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 152074 0
Australia
Phone 152074 0
+61 7 3138 8224
Fax 152074 0
Email 152074 0
[email protected]
Contact person for public queries
Name 152075 0
Alexander Terrill
Address 152075 0
Queensland University of Technology, 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 152075 0
Australia
Phone 152075 0
+61 7 3138 8224
Fax 152075 0
Email 152075 0
[email protected]
Contact person for scientific queries
Name 152076 0
Alexander Terrill
Address 152076 0
Queensland University of Technology, 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 152076 0
Australia
Phone 152076 0
+61 7 3138 8224
Fax 152076 0
Email 152076 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Data repository: Data will be made available on QUT's publicly accessible data repository, via https://data.researchdatafinder.qut.edu.au

Are there extra considerations when requesting access to individual participant data?
No


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.