None listed
Conditions
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.
Interventions
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
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.
Sponsors
University of South Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed