Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001258145
Ethics application status
Approved
Date submitted
21/08/2019
Date registered
11/09/2019
Date last updated
16/12/2020
Date data sharing statement initially provided
11/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of the impact of foot type on efficacy of anti-pronatory strapping and orthotic devices
Scientific title
Investigation of the impact of foot type on efficacy of anti-pronatory strapping and orthotic devices among podiatry patients over 18 years receiving biomechanical interventions
Secondary ID [1] 299081 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Foot pronation 314111 0
Condition category
Condition code
Musculoskeletal 312489 312489 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will investigate the potential link between a patients foot type and the impact of anti-pronatory interventions. The patients foot type will be defined as the level of pronation (how much the foot rolls in) based on the Foot Posture Index (FPI-6).

Participants will be those aged over the age of 18 attending the Charles Sturt University podiatry service for treatment or foot pain or pathology, who are provided with an anti-pronatory intervention. The study will be conducted as a component of the patients normal podiatry consultation, and the interventions and assessment used will be consistent with those already being used within the podiatry service, meaning no additional commitment will be required by the patient. Standard biomechanical assessments will be performed (such as neutral and resting calcaneal stance positons, Jack’s test, ankle and 1st metatarsophalangeal joint range of motion, etc), although the assessment information to be retained for this study will be the Foot Posture Index, supination resistance test and lunge test results.

The anti-pronatory interventions (measures used to stop the foot rolling in) will include a standard strapping technique using rigid sports tape and orthotic devices (inserts for shoes). These will be recommended and initiated at the discretion of the podiatry student and the Clinical Educator, and will be conducted independent of the researchers. The strapping technique used will be a low-dye strapping (as described by Landorf et al. (2005), JAPMA 95(6): 525-530.), and is very commonly used as a preliminary treatment method for conditions such as plantar fasciitis and tibialis posterior dysfunction. Orthotic devices will be prescribed at the discretion of the podiatry student and the supervising Clinical Educator, and will be conducted independent of the researchers. This prescription used will be based on the assessments performed by the podiatry student and the Clinical Educator, and will be intended to address the specific functional needs of the patient/participant.

The initial three dimensional assessment will be completed on the same day the intervention is initiated, and will involve the participant being assessed both with and without the antipronatory intervention (ie. with and without orthoitcs in shoes, or with and without low-dye strapping applied). Three dimensional assessment will be conducted while the patient stands on their dominant foot for 30 seconds, their non-dominant foot for 30 seconds, both feet for 30 seconds; and during the completion of five walking trials 15 meters in length.

Should the participant receive a low-dye strapping intervention, it is assumed the patient will wear the strapping for 2-3 days and then remove the strapping. The patient may or may not be asked to replace the strapping in their own time. Should the participant receive orthotic devices, it is typical to advise gradual increase in use over the space of a week (ie. increase by 1hr every day), and wear the devices all the time from the second week onwards. Depending on the requirements of the podiatry student and the clinical educator, the participant will most likely return for review in somewhere between 2 and 4 weeks. Three dimensional assessment will be conducted at the first day of treatment, and at all subsequent review consultations. The duration of engagement with the study will vary depending on the participants clinical progress, by is expected to involve 2-3 consultations over the space of 4-8 weeks. The wash-out period between testing sessions are expected to be a minimum of two weeks.

Patient compliance will not be logged by any formal means, however, the podiatry student and the Clinicial Educator will typically make notes regarding patient compliance at all review consultations.
Intervention code [1] 315352 0
Treatment: Devices
Comparator / control treatment
This study has been designed as a crossover study. Participants will act as their own controls as they will be assessed both with and without the prescribed intervention (orthtoics or strapping).

When performing three dimensional analysis, two conditions will be assessed in a single session. When using a low-dye strapping, the initial assessment condition will always involve no intervention. The participant will then be given a 5 minute break in which time they will have the tape applied and will be able to put their shoes back on. The second assessment condition will be strapping intervention. When using orthotic intervention, the initial condition will be randomised (either orthotics in shoes, or no orthoitcs in shoes) using a flip of a coin. The participant will then be given a 5 minute break in which time they can put their orthotics in their shoes/take their orthotics out of their shoes and will be able to put their shoes back on. The second assessment condition will then be assessed.

The duration of engagement with the study will vary depending on the participants clinical progress, by is expected to involve 2-3 consultations over the space of 4-8 weeks. The wash-out period between testing sessions are expected to be a minimum of two weeks.
Control group
Active

Outcomes
Primary outcome [1] 321132 0
Balance changes (centre of pressure assessment) while standing stationary on a force platform with and without the anti-pronatory intervention with both legs.
Timepoint [1] 321132 0
Participants will be assessed at the time the treatment is provided (ie. when strapping is applied or when orthotic devices are issued), and at all subsequent review consultations (typically two review consultations at 2-4 weeks, and again at 4-6 weeks).
Primary outcome [2] 321217 0
Balance changes (centre of pressure assessment) while standing stationary on a force platform with and without the anti-pronatory intervention with the dominant leg only.
Timepoint [2] 321217 0
Participants will be assessed at the time the treatment is provided (ie. when strapping is applied or when orthotic devices are issued), and at all subsequent review consultations (typically two review consultations at 2-4 weeks, and again at 4-6 weeks).
Primary outcome [3] 321218 0
Balance changes (centre of pressure assessment) while standing stationary on a force platform with and without the anti-pronatory intervention with the non-dominant leg only.
Timepoint [3] 321218 0
Participants will be assessed at the time the treatment is provided (ie. when strapping is applied or when orthotic devices are issued), and at all subsequent review consultations (typically two review consultations at 2-4 weeks, and again at 4-6 weeks).
Secondary outcome [1] 374096 0
Investigate what kinematic changes occur at the ankle in the frontal, sagittal and transverse planes) during walking gait in response to anti-pronatory interventions (ie. anti-pronatory strapping with rigid tape, pre-fabricated orthotics, semi-custom orthotics, custom orthotics).

Kinematic investigation will utilise an 8 camera Vicon 3D motion analysis system and Nexus software to capture data; and Visual 3D for data analysis and export. Frontal, sagittal and transverse plane joint angle values will be obtained at initial contact (IC), FPOST (the point of maximum posterior ground reaction force between IC and TO), mid-stance, FANT (the point of maximum anterior ground reaction force between IC and TO), and Toe-off (TO). Maximum values in each of the three planes will also be obtained.
Timepoint [1] 374096 0
Participants will be assessed at the time the treatment is provided (ie. when strapping is applied or when orthotic devices are issued), and at all subsequent review consultations (typically two review consultations at 2-4 weeks, and again at 4-6 weeks).
Secondary outcome [2] 374351 0
Investigate what kinematic changes occur at the knee in the frontal, sagittal and transverse planes) during walking gait in response to anti-pronatory interventions (ie. anti-pronatory strapping with rigid tape, pre-fabricated orthotics, semi-custom orthotics, custom orthotics).

Kinematic investigation will utilise an 8 camera Vicon 3D motion analysis system and Nexus software to capture data; and Visual 3D for data analysis and export. Frontal, sagittal and transverse plane joint angle values will be obtained at initial contact (IC), FPOST (the point of maximum posterior ground reaction force between IC and TO), mid-stance, FANT (the point of maximum anterior ground reaction force between IC and TO), and Toe-off (TO). Maximum values in each of the three planes will also be obtained.
Timepoint [2] 374351 0
Participants will be assessed at the time the treatment is provided (ie. when strapping is applied or when orthotic devices are issued), and at all subsequent review consultations (typically two review consultations at 2-4 weeks, and again at 4-6 weeks).
Secondary outcome [3] 374352 0
Investigate what kinematic changes occur at the hip in the frontal, sagittal and transverse planes) during walking gait in response to anti-pronatory interventions (ie. anti-pronatory strapping with rigid tape, pre-fabricated orthotics, semi-custom orthotics, custom orthotics).

Kinematic investigation will utilise an 8 camera Vicon 3D motion analysis system and Nexus software to capture data; and Visual 3D for data analysis and export. Frontal, sagittal and transverse plane joint angle values will be obtained at initial contact (IC), FPOST (the point of maximum posterior ground reaction force between IC and TO), mid-stance, FANT (the point of maximum anterior ground reaction force between IC and TO), and Toe-off (TO). Maximum values in each of the three planes will also be obtained.
Timepoint [3] 374352 0
Participants will be assessed at the time the treatment is provided (ie. when strapping is applied or when orthotic devices are issued), and at all subsequent review consultations (typically two review consultations at 2-4 weeks, and again at 4-6 weeks).

Eligibility
Key inclusion criteria
Participants in this study will be new and existing patients attending the CSU-CEW for biomechanical intervention. There will be an emphasis on those attending third year clinics which focus on new patients and patients with foot pain or biomechanical needs.

Participants will need to be over the age of 18, and must have signed a consent form prior to their initial podiatric consultation. As the data collected will be standard clinical data, and not require patients to engage with anything aside from standard clinical assessment and intervention (which would have been the case even in the absence of the study), this will satisfy the inclusion criteria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusions will be applied to those with conditions known to impair balance, gait, or both. For that reason, participants with known neurological or neuromuscular conditions; current lower limb fractures; lower limb surgery within the last 6 months; musculoskeletal injury within the last 6 months requiring an absence of greater than 1 week from work or sport; or allergies to sports tape will be excluded from participation in the study.

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)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The researchers will aim to engage at least 24 participants. G*Power was used to complete the sample size calculations. Participants will be initially assessed based on their foot posture index results, meaning participants will be identified as being supinated (-1 to -4), neutral (0 to 5), pronated (6 to 9) or highly pronated (10 to 12). Given that the aim of data analysis is to compare various joint angle means between the four groups, the most appropriate G*Power settings for sample size analysis were F tests under Test family, and ANOVA: Fixed effects, special, main effects and interactions as the statistical test. An a priori analysis was conducted determine the required sample size. The effect size f was determined using the direct approach, and having selected a partial eta-squared value of 0.5, the calculated effect size (f) was 1. When combined with an alpha level of error of 0.05 and a power of 95%, and entering the 4 groups based on FPI scoring, a total sample size of 22 was calculated.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/09/2019
Actual
4/11/2019
Date of last participant enrolment
Anticipated
19/08/2021
Actual
Date of last data collection
Anticipated
26/08/2021
Actual
Sample size
Target
24
Accrual to date
22
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 27627 0
2640 - Albury

Funding & Sponsors
Funding source category [1] 303620 0
University
Name [1] 303620 0
Charles Sturt University - School of Community Health
Country [1] 303620 0
Australia
Primary sponsor type
University
Name
Charles Sturt University - School of Community Health
Address
Elizabeth Mitchell Drive
Thurgoona
NSW 2640
Country
Australia
Secondary sponsor category [1] 303708 0
None
Name [1] 303708 0
Address [1] 303708 0
Country [1] 303708 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304146 0
Charles Sturt University - Human Research Ethics Committee
Ethics committee address [1] 304146 0
Ethics committee country [1] 304146 0
Australia
Date submitted for ethics approval [1] 304146 0
04/07/2019
Approval date [1] 304146 0
24/07/2019
Ethics approval number [1] 304146 0
H19227

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

Contacts
Principal investigator
Name 95954 0
Mr Luke Donnan
Address 95954 0
Charles Sturt University
PO Box 789
Thurgoona NSW 2640
Country 95954 0
Australia
Phone 95954 0
+61 2605 19258
Fax 95954 0
Email 95954 0
[email protected]
Contact person for public queries
Name 95955 0
Luke Donnan
Address 95955 0
Charles Sturt University
PO Box 789
Thurgoona NSW 2640
Country 95955 0
Australia
Phone 95955 0
+61 2605 19258
Fax 95955 0
Email 95955 0
[email protected]
Contact person for scientific queries
Name 95956 0
Luke Donnan
Address 95956 0
Charles Sturt University
PO Box 789
Thurgoona NSW 2640
Country 95956 0
Australia
Phone 95956 0
+61 2605 19258
Fax 95956 0
Email 95956 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
As the data collected in linked to patient clinical data, ethical approval stipulated the data collected would be used for the purpose of this study only.


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.