Clinical Details

Safo Clinical Trials

Since it’s development in 1998, there have been two clinical research projects looking into how the SAFO improves mobility and quality of life for its users.

The first was led by Professor Ian Swain at the Department of Medical Physics and Biomedical Engineering at Salisbury District Hospital in 2001.

The second took place at the University of Strathclyde under Peter McLachlan B.Sc (Hons) in 2003.

The results to date prove that the SAFO does have advantages over the rigid plastic AFO particularly when it comes to support, flexibility, stability and comfort.

Papers:

• A paediatric project report based on a 12 month case study looking at the effectiveness of the SAFO in five children affected with CP.
  
• Comparison of Silicone-Ankle-Foot Orthoses vs Plastic Ankle Foot Orthoses in subjects with Lower Motor Neurone Lesions using the CODA mpx30 gait analysis system.
  
• The use of a silicone boot orthosis on the speed and effort in walking in patients with lower motor neuron lesions.

Advantages and disadvantages of the SAFO

ADVANTAGES:

• Cosmetically discrete, available in a choice of 7 colour pigments as well as primary colours and fun designs.
• Replicates normal foot action, and therefore walking is less mechanical in feel.
• Flexible, and therefore particularly helpful on uneven ground.
• Normal alignment of ankle at mid-stance makes standing and turning on the spot easier.
• Exact match around the foot reduced the risk of pressure areas, callouses and sores.
• Fits into normal footwear.
• Can be worn without footwear for swimming, showering or relaxing about the house.
• Easy maintenance. (rinse with soapy water)
• Easy to put on and take off.

DISADVANTAGES:

• Not suitable for strong spasticity.
• Not suitable for patients with fluctuating oedema.
• Silicone is not a breathable material.

Patient Comments

When first trying out their new SAFO’s these are typical patient reactions:

'Total freedom'
'I feel so much more stable'
'My balance is better' ('I can stand still')
'I feel more confident'
'I can feel the soles of my feet'
'I know where my feet are in space'

After three months, typically these are the kind of things wearers notice:

'It is easier going up and down stairs'.
'I feel more stable on uneven ground'
'Driving the car I can feel the pedals'
'My legs do not ache so much driving'
'I am not so tired after walking'
'Not so nervous walking around the pool'
'My Quality of life has improved'

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