Materials

Moulded from high performance polypropylene, Flexyfoot uses the unique integral hinge properties of polymers. When correctly designed, the molecules in a polypropylene hinge align themselves across the hinge line, making it almost indestructible. The more the hinge area is flexed, the stronger it becomes. The FlexyFoot bellows consists of a series of multiple hinges and has a life span in excess of 100,000 compressions or 200,000 steps. Tested on a purpose built rig, this is roughly the equivalent of about 60 miles of heavy walking.

*** PHOTO=cross section visual of the bellows ***

ISO Testing

FlexyFoot has been tested to ISO EN standards:

BS ISO  24415-1:2009

Tips for assistive products for walking – Requirements and test methods Part 1: Friction of Tips Specifies requirements and test methods for the friction between the tips for assistive products for walking and the walking surface. The requirements and test method are based on a usage of tips for ordinary gait on the dry and flat walking surface.

Back-to-back testing against a standard ferrule showed that Flexyfoot has at least 50% more grip.

BS ISO 24415-2

Tips for assistive products for walking – Requirements and test methods Part 2: Durability of tips for crutches. This is a draft standard which specifies a test procedure that consists of a simulated walking with a dynamic maximum applied load of 500N (approximately 50KG). The load is applied as the aid travels through the typical angle of walking and is then removed at the end of each ‘step’.

Ferrules are regarded as replaceable parts and we set the test at 100,000 cycles. A back-to-back test showed that Flexyfoot was still serviceable at 100,000 cycles (about 60 miles) whilst the standard ferrule was unacceptably worn down at 50,000 cycles.

FlexyFoot has also been tested for performance at freezing temperatures and remains in perfect working order up to -20C.

The friction test was performed by Satra, the world’s leading research and technology centre www.satra.co.uk.

ISO The International Organization for Standardization www.iso.org

CE Marking

CE marking certifies that a product has met EU consumer safety, health or environmental requirements. FlexyFoot is classified as a Class I device and so can be self-certified, as long as due diligence is observed and supporting materials are supplied. To help, we asked medical device consultant, Dr Jed Place of Medical Device Consultants, to guide us through this highly technical and detailed process.

BIS The Department for Business Innovation and Skills - The UK’s official CE site www.berr.gov.uk

MHRA Registration

Registered with the MHRA (the Medicines and Healthcare products Regulatory Agency) in December 2009.

ATcare User Trials

ATcare is an independent body set up with a 2.75M budget from the London Development Agency to help develop and advise on assistive technology. Individuals were recruited to represent the two target groups that may realize the most benefit from the FlexyFoot ferrule: walking stick and crutch users. The eligibility criteria for participation were (1) Individuals with at least 3 month’s experience of walking with either a stick or crutch and (2) who were likely to need assistive walking equipment on an ongoing basis.

The first stage was focus group sessions where participants were asked about their experience of walking aids and opinions of the FlexyFoot ferrule. Participants were then provided with prototypes to use at home. Feedback was extremely positive.

“It’s nice to have a bit of bounce [...] Much more comfortable.”
“Just being able to turn does make a big difference.  [...] I like it.”
“Great grip, even in the wet - easy to fit.”
“The pain in the shoulder and under my arm has improved.”
“FlexyFoot is silent - good if you have wooden floors and people underneath!”
“I feel better and can walk freely over rough surfaces.”

ATcare, Transforming lives through technology www.atcare.co.uk

Professional Endorsements and Awards

Robert Simonis FRCS, Consultant Orthopaedic Surgeon, St Peter’s Hospital, Surrey UK

“I have no hesitation in recommending FlexyFoot. It is safer, quicker and easier to use than a standard crutch ferrule. The tread is always flat on the ground, maximising grip and preventing slippage.  Shock absorbency and free rotation reduces strain on the arms and upper body. Patients of all ages, shapes and sizes, find them more comfortable and having used them will not go back to using an old fashioned crutch.”

ATcare trialled Flexyfoot. AT Care is a ‘not for profit’ organisation set up to help develop assistive technology

The enABLEe awards 2009 named FlexyFoot as a finalist.  The enABLE Innovation Awards aim to demonstrate and promote the products and services available to disabled consumers and their carers, to meet their independent living needs. The Awards will provide the UK’s first benchmark of excellence for such life-changing products: www.enableawards.co.uk