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Trial registered on ANZCTR


Registration number
ACTRN12613000920796
Ethics application status
Approved
Date submitted
9/08/2013
Date registered
20/08/2013
Date last updated
19/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study on function and symptom changes with the use of foot orthoses in the flat footed adult.
Scientific title
Do adult people with symptomatic flexible pes planus using functional foot orthoses, when compared to non-functional insoles, improve gait efficiency (energy cost and functional levels) and improve foot health.
Secondary ID [1] 282989 0
Nil known
Universal Trial Number (UTN)
U1111-1146-5985
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptomatic flexible pes planus 289821 0
Condition category
Condition code
Musculoskeletal 290174 290174 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 290225 290225 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Custom made functional foot orthoses are prescribed customised devices manufactured from impressions of the participant's feet. The impressions are used to form positive moulds, which are modified across the rearfoot, midfoot and forefoot as per individual prescription requirements. The functional foot orthoses will be formed from the modified positive casts and moulded in semi-rigid polypropylene with 3mm multiform (thin blown rubber) top covers. Participants will be given written instructions to wear the orthoses for increasing increments of one hour per day (day 1 = 1 hour, day 2 = 2 hours etc.) until they are wearing the orthoses full time with comfort. The 'wearing in' of orthoses is individual and it is expected that some participants will 'wear them in' quicker than others. At the follow up session participants will be asked to report the percentage of time the orthoses has been worn over the previous four weeks.
Intervention code [1] 287709 0
Treatment: Devices
Comparator / control treatment
The non-functional (soft) insoles will be manufactured using the same casting method and modifications as the functional foot orthoses. These devices will be manufactured from 3mm multiform (thin blow rubber) only and therefore will be compressible under body weight. Participants will be given written instructions to wear the orthoses for increasing increments of one hour per day (day 1 = 1 hour, day 2 = 2 hours etc.) until they are wearing the orthoses full time with comfort. The 'wearing in' of orthoses is individual and it is expected that some participants will 'wear them in' quicker than others. At the follow up session participants will be asked to report the percentage of time the orthoses has been worn over the previous four weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 290207 0
Primary outcome will be a measured change in energy expenditure and/or increased walking ability. Increased walking ability will be demonstrated by completing a known distance walk test (200 metres) in reduced time or by walking a greater distance during a timed distance test (six minute walk test). Participants will complete both walking tests wearing their allocated orthoses (functional or non-functional) and in their shoes alone in a randomised order. Energy expenditure will be measured by an armband monitor worn on the upper arm of the participant during the testing procedure (SenseWear(copyright)).
Timepoint [1] 290207 0
The procedure will be completed at two time points: The day the participant receives their allocated orthoses (dispense) and four weeks later following acclimatisation of the orthoses (follow up).
Secondary outcome [1] 304103 0
The secondary outcome will be self-reported changes in foot health levels. Pain and fatigue will be measured using 100 mm visual analogue scales (VAS) and overall foot health changes will be measured using the foot health status questionnaire (FHSQ) which is a validated survey covering short and long term pain, function and general foot health.

Timepoint [1] 304103 0
Both the FHSQ and the VAS will be completed at three time points: During the participants initial assessment (assessment), the day the participant receives their allocated orthoses (dispense) and four weeks later following acclimatisation of the orthoses (follow up).

Eligibility
Key inclusion criteria
Symptomatic flexible pes planus where the scale of pes planus has been mesured (by a podiatrist independent to the research) to be equal or greater than +7 on the Foot Posture Index - 6 item version (FPI-6). The FPI-6 is a validated tool to determine foot posture and falls within the bounds of normal practice within the podiatry clinical setting.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Please will be excluded if they: currently wear orthoses (or have within the past 6 months), have an acute or chronic injury or condition affecting lower limb function, are unable to walk a minimum of six minutes unaided or report severe pain (greater than 60 mm on 100 mm VAS) associated with their pes planus as alternative management may be required.

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)
People will be recruited from the University of South Australia Podiatry clinic where a dedicated adult biomechanical examination (and orthoses) clinic is run once a week during teaching periods. Potential participants will be given an information sheet by the clinic manager, undergo an initial assessment by an independent podiatry tutor and if criteria is satisfied and they are willing and able to enrol, the participant will receive an invitation to participate by the principal researcher and asked to sign a consent form.
Each participant will be required to attend four sessions; 1. an initial assessment (assessment), 2. biomechanical examination and casting (casting)’; 3. dispense of their orthoses/insoles (dispense) and 4. review of their orthoses/insoles (follow up).
Allocation to either the functional or non-functional orthoses will occur between sessions 2 and 3. Allocation will be sought following the casting of the participant’s feet and the principal researcher will notify the orthotic manufacturing laboratory of the outcome. The principal researcher will not be aware of allocation prior to biomechanical exam and casting. The participant will remain blinded to the allocation until the completion of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using an online tool (www.randomization.com) randomization was obtained by a secondary researcher in sets of six allocations to ensure adequate spread of intervention and control allocations if recruitment did not reach the preset target. This list was managed by an independent administrator. The final allocation sequence was held in an electronic form on a password protected PC, accessible only by the administrator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive statistics were used to describe participant characteristics at baseline and median differences between groups at baseline and follow up.
Normality of data were assessed using Shapiro-Wilks tests (p = 0.05). Where data were not normally distributed, appropriate non-parametric equivalent tests were used or outcomes were subjected to rank transformation prior to analysis with statistical significance set at p = 0.05.
Due to the trial being purposely designed as a pilot, an on-protocol (completer) analysis was used to determine intervention effects (Portney & Watkins 2009).
Group differences at baseline were determined using Mann-Whitney U-tests. Where baseline differences existed in an outcome variable, investigation of intervention effects on group, time and condition were explored using ANCOVA to allow for regression to the mean (group x 2, time x 2, condition x 2), (Owen & Froman 1998) . Where data displayed heterogeneous error variance (p = 0.05), differences between the ‘no device’ and ‘with device’ condition were explored using student t-test.
Standardised mean differences (SMDs) and their 95% confidence intervals (CI) were calculated and interpreted as directed for Cohen’s d, where: small effect ? 0.20 to = 0.50; medium effect ? 0.50 to = 0.80; and large effect ? 0.80 (Portney & Watkins 2009, p.649). For the purpose of this thesis, SMDs of less than 0.20 were considered very small.

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)
SA
Recruitment postcode(s) [1] 7264 0
5001 - Adelaide

Funding & Sponsors
Funding source category [1] 287764 0
University
Name [1] 287764 0
University of South Australia
Address [1] 287764 0
School of Health Sciences
City East Campus
North Tce
Adelaide
South Australia
5001
Country [1] 287764 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
School of Health Sciences
City East Campus
North Tce
Adelaide
South Australia
5001
Country
Australia
Secondary sponsor category [1] 286489 0
Commercial sector/Industry
Name [1] 286489 0
Footwork Podiatric Laboratory
Address [1] 286489 0
2/27 - 28 Carl Court, Hallum, Victoria, South Australia 3803
Country [1] 286489 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289711 0
Human Research Ethics Committee
Ethics committee address [1] 289711 0
University of South Australia
PO Box 2471
Adelaide 5001
Ethics committee country [1] 289711 0
Australia
Date submitted for ethics approval [1] 289711 0
09/08/2013
Approval date [1] 289711 0
03/10/2013
Ethics approval number [1] 289711 0
0000030996

Summary
Brief summary
Participants will be required to have measurable flexible pes planus, meet inclusion and exclusion criteria and be willing and able to attend four sessions at the University of South Australia’s biomechanics clinic. Participants will be aware that they will randomly receive either a soft or firm orthoses.
Initial assessment: If consent and inclusion criteria are satisfied foot health measures will be undertaken and a practice session of walking tests completed.
Casting: Casting of the feet will be undertaken. Randomising of allocation occurs into semi-rigid functional foot orthoses or soft, non-functional insoles. A practice session of walking tests completed.
Dispense: Foot health measures undertaken. Inserts are dispensed. Two walking tests completed wearing armband monitor with and without inserts in participants shoes (randomised order) supervised by principal researcher. Walking tests are timed and recorded by an independent and blinded person.
Follow up: Foot health measures undertaken, two walking tests completed wearing armband monitor with and without inserts in participants shoes (randomised order) supervised by principal researcher. Walking tests are timed and recorded by an independent and blinded person.
Data Analysis: Data will be collated and entered into the computer by an independent person blinded to the allocation. Statistical analyses will determine if measured changes between the insert conditions (functional vs non-functional and shoes vs insert) are significant with a predetermined clinically significant outcome being set at 5% improvement for both energy cost and walking distance changes. Foot health will be reported as a percentage change for pain and fatigue VAS outcomes, the FHSQ will be transformed into an overall foot health score as determined by the protocol for this tool. Statistically analyses will determine if (any) measured changes are significant.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42062 0
Ms Helen Banwell
Address 42062 0
School of Health Sciences
University of South Australia
City East Campus
North Tce
Adelaide
South Australia 5001
Country 42062 0
Australia
Phone 42062 0
+61 8 8302 1256
Fax 42062 0
+61 8 8302 2853
Email 42062 0
helen.banwell@mymail.unisa.edu.au
Contact person for public queries
Name 42063 0
Ms Helen Banwell
Address 42063 0
School of Health Sciences
University of South Australia
City East Campus
North Tce
Adelaide
South Australia 5001
Country 42063 0
Australia
Phone 42063 0
+61 8 8302 1256
Fax 42063 0
+61 8 8302 2853
Email 42063 0
helen.banwell@mymail.unisa.edu.au
Contact person for scientific queries
Name 42064 0
Dr Dominic Thewlis
Address 42064 0
School of Health Sciences
University of South Australia
City East Campus
North Tce
Adelaide
South Australia 5001
Country 42064 0
Australia
Phone 42064 0
+61 8 8302 1540
Fax 42064 0
+61 8 8302 2766
Email 42064 0
dominic.thewlis@unisa.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