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 been tested to 500,000 compressions or 1M steps with a load of 50KG. That is the equivalent of 300 miles of walking.

ISO Testing

Flexyfoot has been put through a long-term development test programme with each feature tested for performance, endurance and safety before moving to the next stage. We designed and built our own test machines at the start because there was no standard that would subject Flexyfoot to real-life conditions.

Life Expectancy and Endurance

Part way through the development, a draft standard, BS ISO 24415-2 was published by British Standards that was almost identical to the test programme that we designed and so we built a test rig that would test Flexyfoot to the draft standard. It basically ‘walks’ the walking aid whilst applying a load of 50kg during the compression cycle and the ferrule or tip is tested for 500,000 cycles and must not be split nor any internal parts visible.

We initially carried our these tests in-house using our test rig and then asked SATRA, a highly regarded independent test house to repeat the tests on three production samples (as per the standard). Each sample takes around 13 days of 24 hours continues testing. The results exceeded our expectations, there was no splits or damage to the bellows, collar or rubber tread and the fit of the foot into the collar was as new along with the fit to the aid.

Tread wear was also excellent, a point borne out by customer feedback who say that Flexyfoot lasts around 4-8 times longer than a standard ferrule (depending on the user, the aid and the conditions).

We tested a standard ferrule on the rig and the tread had totally worn away on one side within 35,000 cycles.

We were also concerned about cold weather performance (not part of the BS test) and so tested Flexyfoot at -25 degrees in a cold chamber to ensure that the cold would not make the plastic brittle and liable to cracking.

Grip

Because the entire tread makes full contact with the ground, we expected that Flexyfoot’s grip would be very significantly better than a standard ferrule that only has part of the tread in contact, particularly during the initial placement when the person is at their most unstable.

The BS ISO 24415-1:2009 test is designed to measure the grip when the ferrule makes contact with the ground at an angle of 20 degrees. This simulates someone placing their walking aid on the ground during a step. A load is applied to the ferrule whilst is pushed across a glass plate and the friction between ferrule and plate is measured.

Satra tested three production samples and compared these with a standard ferrule. Flexyfoot has at least 50% more grip than a standard ferrule and the wet surface performance was also good. These results are borne out by customer feedback who say they feel much more secure, less likely to slip particularly in the wet.

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

Runneymede Patient Trails

A six-month patient trail was run by the Physiotherapy Department at the BMI Hospital at Chertsey run by Head of Physio: Dallas Newton. Flexyfoot was given to a range of patients including full and partial weight bearing people in rehabilitation. The results have been written up for the physiotherapist’s professional magazine. Patients were asked to fill in a detailed form to describe their experiences and to compare Flexyfoot with a standard product. The results were:

100% of patients felt safer and more secure
100% of patients said they had less muscoskeletal pain
100% said they preferred Flexyfoot.
85% said they would pay the extra for Flexyfoot
The remaining 15% said they were unsure.

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

Flexyfoot was selected for an award by the British Healthcare Trades Association Excellence Awards 2010 and shortlisted in the Pharmacy Awards in the new products section.