PLAN ESTATAL DE EDUCACIÓN 2001-

Only if the participant was classified as asymptomatic from the screening assessment in Phase 1 were Phase 2 and Phase 3 of data collection commenced.

Between 4, to 6 participants were screened per day. On the same day both Data set A and Data set B were collected. All data collected from the three phases was stored anonymously as each participant was assigned a participant number, and could not be identified from the data collected in Data set A and Data set B.

5.2.2 Phase 1 screening assessment protocol

For the purpose of this investigation, and to be able to provide suitable conclusions to Research Question 1 and 2 it was necessary to collect data from “normal” participants. For this investigation and as used in the majority of contemporary research (For example: Leardini et al 2007, Cornwall and McPoil 1999a, Hunt et al 2001a, Jenkyn and Nicol 2007, Lundgren et al 2007) the term “asymptomatic” which

169 is described as free of symptoms or not causing symptoms” (Youngson 2004) was used to classify participants as “normal.”

All participants were assessed using a specifically designed screening assessment protocol. This was conducted prior to the commencement of Phase 2 and Phase 3. The screening assessment protocol followed guidelines by Lorimer et al (2002) and Yates (2012). They suggested that the assessment of a patient should include the medical history of the patient, as well as an examination of the musculoskeletal, vascular and neurological systems of the foot, leg and lower limb. Any participants who did not meet the inclusion criteria, and were therefore classified as symptomatic were excluded from this investigation. No further data collected from them.

The screening assessment protocol of all participants was conducted by the Principal Investigator. Both feet were assessed as Data set A and Data set B were to be collected from both feet. The screening assessment included:

General participant information

The weight and the height of the participant were measured and recorded to enable the calculation of the Body Mass Index (BMI). The BMI was calculated using the NHS BMI online calculator (NHS 2012) for each participant. The inclusion criteria for the BMI classification of a participant in this investigation was defined from BMI: 16-29. This includes both “healthy” and “overweight” classifications. Participants were excluded from this investigation if the BMI classification was less than 16 indicating “severely underweight,” or equal to and greater than 30 indicating “obese.” The calculation of BMI is described by the National Institute for Health

170 and Clinical Excellence (NICE) (2006) as a widely accepted model to determine if a patient is overweight or obese, and therefore at risk of health problems and co- morbidity.

Each participant was also asked to grade their level of activity from 0 (not active) to 5 (very active, e.g sport/go to the gym 5 or more sessions per week).

Medical history

Participants were excluded from this investigation if they had been diagnosed with an acute or chronic illness (e.g. type 1 or 2 diabetes, rheumatoid arthritis or coronary heart disease), or were taking long term medication including pain killers. Participants currently suffering from, or had previously suffered from any musculoskeletal injury, trauma or pain in the foot, leg, lower limb or lower back were excluded from this investigation. Participants who were wearing or had previously worn orthotics, even if they were now symptom free were excluded from this investigation. This is because prior to orthotic intervention the individual was not symptom free and the individual may display a different biomechanical function of the foot, leg and lower limb when walking barefoot, then when they are wearing the orthoses.

Visual assessment of the foot

Participants were excluded from this investigation if either foot displayed mild to severe structural foot deformity, such as hallux-abducto valgus, or any form of swelling or redness in the foot, leg or lower limb.

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Neurological sensory assessment of the foot

A neurological assessment aims to test an individual’s sensory response to different forms of stimuli (Yates 2012). The key elements of a neurological assessment according to Foster (2006) must include an examination of an individual’s response to the application of pressure and vibration to the foot.

To assess the participant’s response to pressure, a 10g monofilament was applied to the heel, fifth metatarsal and the hallux as explained in Yates (2012), Foster (2006) and Williams and Pickup (2005). To assess the participant’s response to vibration, a 128Hz tuning fork was applied to the medial mallelous heel, fifth metatarsal and the hallux as explained in Yates (2012), Foster (2006) and Williams and Pickup (2005). Each apparatus was used separately, and each participant was required to state if they could feel the application of the apparatus and where it was applied on their foot.

Any participant unable to detect the application, or identify the location of either or both neurological assessment tools was excluded from this investigation.

Vascular assessment of the foot

A simple vascular assessment was conducted. This involved the palpation of dorsalis pedis pulse and posterior tibial pulse. Both limbs were also checked for signs of vascular disease. Participants were excluded if the Principal Investigator failed to locate either pulse, there were signs of vascular disease in either limbs or they were suffering from or had suffered from any form of acute or chronic circulatory or vascular disease or were now taking medication for a presenting condition

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5.2.3 Outcome from Phase 1 screening assessment

From the 140 participants recruited, 123 participants were assessed using the screening assessment protocol, with 107 participants classified as asymptomatic from this cohort (Figure 5.1).

Participants were allocated a time on the same day of the screening assessment protocol to attend the podiatry clinic to be assessed with the assessment protocol described in Data set A, and another time to attend the podiatry gait lab for the instrumented gait analysis described in Data set B.

Figure 5.1 - Process of inclusion and exclusion of participants for this investigation Phase 1: Assessed for eligibility with

screening assessment (n=140)

Excluded (n=33)

- Not meet inclusion criteria (n=16) - Decided not to participate (n=6) - Did not attend (n=11)

Suitable for data collection (n=107)

Phase 2: Data set A:

Anthropometric data from a static based biomechanical assessment of the foot

Phase 3: Data set B: Instrumented gait analysis of the foot and leg

Excluded (n=7)

- Incomplete Data set A or Data set B for participant (n=5)

-Poor quality of data (n=2)

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5.3 Data set A: Anthropometric data from a static based