Contexto referencial

Footwear advice and provision

Participants were asked to bring their indoor and outdoor footwear to their REFORM appointment. The podiatrist assessed the following characteristics of the participant’s footwear that have been identified in the literature as risk factors for falls in older people:12_{correct size, method of fastening, height and width} of the heel, thickness of outsole, heel counter stiffness, longitudinal sole rigidity, sole flexion point and tread pattern. Footwear was assessed as inappropriate if it had any of the following characteristics: (1) heel height>4.5 cm, (2) no adjustable fixation of the upper, (3) no heel counter or a heel counter that could be depressed to>45°, (4) a fully worn/smooth/thin sole, (5) heel width narrower than the participant’s heel width by≥20% or (6) incorrect shoe size. Participants were counselled about any hazardous footwear features identified during the assessment and advised on safer footwear characteristics to select when purchasing footwear in the future.

If a participant’s footwear was deemed inappropriate, and they did not own a suitable pair of shoes that they could be advised to wear instead, new footwear was provided where possible. The podiatrists ordered footwear directly from one of two companies participating in the Healthy Footwear Guide scheme:26_DB shoes (DB Shoes Ltd, Rushden, UK) or Hotter company (Beaconsfield Footwear Limited, Skelmersdale, UK). Not all of the footwear manufactured by these companies fulfil the characteristics of a‘safe’shoe; therefore, participants chose footwear from a catalogue of preselected makes and models that the trial team had previously assessed as being suitable. In order to avoid incentivising participants to take part in the study, participants were told about footwear provision only if they were assessed as requiring new footwear. Foot orthoses

Participants were considered for fitting with an X-Line standard orthotic insole (Healthystep, Mossley, UK). If required, the insole was modified with prefabricated self-adhesive additions to improve the participant’s foot posture. For those participants already wearing an orthotic insole, the treating podiatrist made a clinical judgement on the suitability of replacing the insole with one used in the trial. If the participant’s current insole was replaced, then any current prescription or modifications were repeated. If, however, the podiatrist deemed it to be detrimental to replace their current insole with that of the trial insole, then the participant continued to wear their own insole and this component of the intervention was considered to be addressed. In cases in which the treating podiatrist felt that the participant required more or a prescription that the trial insole could not provide, then a referral was made in line with routine practice. Participants were advised to‘wear-in’the orthotic insole slowly. It was suggested that it should be worn for 1 hour on the first day and wear time increased by a few hours each day, and that the insole could be transferred from one pair of shoes to another.

Home-based foot and ankle exercise programme

When safe and appropriate, participants were prescribed a 30-minute home-based foot and ankle exercise programme to be undertaken three times a week, indefinitely. The aim of the exercises was to stretch and strengthen the muscles of the foot and ankle and improve balance. The exercises were based on the programme developed by Spinket al.,23_{which had been adapted for a UK and Irish setting during the} pilot phase of the study. A summary of the individual exercises is listed inTable 1. The podiatrist assessed competence and safety at the baseline appointment through demonstration and participant repetition of the exercises. These were supplemented by an explanatory illustrated booklet and a digital versatile disc (DVD), which the participant took home along with the resistive bands and therapy ball that were required to undertake the exercises. At subsequent appointments the podiatrists reviewed the participant’s exercise techniques and, when required, advised the participant to ensure that the exercises were being conducted safely and as intended.

Routine podiatry care

Participants continued to receive routine podiatry care as separate podiatry appointments in accordance with usual practice. The aim of these appointments was to reduce painful conditions such as corns and calluses that have been found to be associated with an increased risk of falls.

METHODS

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TABLE 1 Summary of the home-based foot and ankle exercises

Activity Description Dosage Increments

Ankle range of motion/warm-up

Sitting, with the knee at 90°. Lift the foot to clear the ground and then rotate the foot slowly in a clockwise direction and then an anticlockwise direction

1 × 10 repetitions for each foot in each direction

None

Ankle inversion strength

Sitting upright, with the hip, knee and ankle at 90°. Invert foot against resistive exercise band. The band should be fixed at 90° to the foot from an additional chair/table leg

3 × 10 repetitions for each foot Increase resistance strength of resistive exercise band Ankle eversion strength

Sitting upright, with hip, knee and ankle at 90°. Evert foot against resistive exercise band. The band should be fixed at 90° to the foot from an additional chair/table leg

3 × 10 repetitions for each foot Increase resistance strength of resistive exercise band Ankle dorsiflexion strength

Sitting, with hip, knee and ankle at 90°. Dorsiflex both feet to end range of motion and hold. Keep pulling feet up towards the body during the hold

Hold feet in dorsiflexion for 3 × 10 seconds Increase repetitions up to a maximum of 10 Intrinsic strengthening, toe plantarflexion strength and toe stretch

Sitting, with hip, knee and ankle at 90°. (1) Use the therapy ball under the toes to stretch the toes. The rest of the foot should be plantigrade. Then curl and point the toes up and over the ball. (2) Use the therapy ball under the toes to stretch the toes. The rest of the foot should be plantigrade. With the heel on/close to the floor, curl the toes over the ball and attempt to pick up the ball with the toes

3 × 10 repetitions for each exercise for both feet. Have a 30-second break between each repetition

Increase up to a maximum of 50 repetitions

Ankle plantarflexion strength

From standing position, rise up onto toes of both feet and then slowly lower back down. Just before the heels contact the floor, rise back up onto the toes

3 × 10 repetitions Increase repetitions up to a maximum of 50

Calf stretch Facing a wall and using hands on the wall for balance, step one foot in front of the other keeping feet hip width apart and hips, knees and feet facing the wall. Bend the knee closest to the wall and keep the back leg straight. Keep both heels in contact with the floor

Hold stretch for 3 × 20 seconds on each leg

Increase the stride length and forward lean to increase the stretch

Proprioception/ balance training

From a standing position and holding on to a work surface/chair/wall for support, stand on one leg. Repeat on the other side

Hold for 30 seconds, repeat for three repetitions

Increase slowly to hold for 1 minute per repetition. If competent, rise up on to toes on the one supporting leg: 3 × 10 repetitions

Podiatrist training to deliver the intervention

The podiatrists delivering the trial intervention attended a half-day face-to-face training session facilitated by the research podiatrist (author LG). The training included instructions on the delivery of the individual components of the intervention including footwear assessment and provision, prescribing and fitting trial insoles and prescribing foot and ankle exercises. Podiatrists were given the opportunity to practice delivering the intervention during role-play sessions. In addition, information about the day-to-day management of podiatry tasks, for example booking appointments or ordering footwear, adverse event reporting and completion of trial paperwork, was provided. When possible, the research podiatrist attended the first participant appointment delivered by each podiatrist to give advice on the delivery of the intervention when requested.

Falls prevention leaflet and trial newsletter

Participants were sent a falls prevention leaflet in the post along with their baseline questionnaire. Participants living in the UK received the Age UKStaying Steadyleaflet27_{and those in Ireland received the} Irish Osteoporosis SocietyFall Preventionleaflet.28

A postal group-specific trial newsletter was sent to participants at 3 months post randomisation, as well as a generic trial newsletter at 12 months. The aim of the newsletters was to keep participants updated with the progress of the trial in an attempt to minimise attrition and improve response rates to postal questionnaires.29_{The 3-month newsletter to the intervention group also included information about how} to undertake the foot and ankle exercises and wear the insoles and it aimed to aid compliance. It included anonymised quotations reporting the benefit some participants had experienced after following the package of care. The content of the newsletter was informed by issues raised by participants with the research team during the course of the trial.