Footjacks Flat Orthotic Version 1
Research type
Research Study
Full title
AN ASSESSMENT OF THE EFFECTS FOOTJACK FLAT ORTHOTIC ON (1) THE FOOT, LOWER LIMBS, PELVIS, AND SPINE COMPARED TO A CONTROL AND A STANDARD ARCH SUPPORT AND (2) ON PAIN AND FUNCTION IN SUBJECTS WITH PES PLANUS AND CHRONIC LOW BACK PAIN OVER A 7 MONTH PERIOD COMPARED TO A CONTROL WITH RANDOM ALLOCATION.
IRAS ID
189788
Contact name
Mark Stern
Contact email
Sponsor organisation
Footjacks Ltd
Duration of Study in the UK
0 years, 8 months, days
Research summary
“A randomly controlled trial to assess the performance of a flat orthotic on subjects all with pes planus causing unlevelling of the pelvis in the frontal plane and chronic low back pain relative to a control.The device will be assessed as to its capacity to: (1) improve pain and function in the joints of the lower limbs, pelvis and spinal regions over a 7 month period; (2) provide comfort in daily use (3) stabilise the feet in high heeled shoes and (4) be safe to wear and (5) global improvement
The trial will include a measurement arm assessing the devices capacity to act as an orthotic and to substantially improve support and function of the feet, pelvis and spine relative to a control and a standard arch support.
In the wearing arm subjects, aged between 18 and 75, will wear the device or a control whenever they are on their feet.The primary outcome measure is the Oswestry low back disability questionnaire assessing changes in low back pain and function. Secondary outcomes include serious adverse events, VAS pain, comfort, global improvement, stability in high heeled shoes and a lower limb functional scale..
Improving support in the lower limb, pelvic and spinal joints it is hoped will reduce pain and improve joint function. If successful, the device could have a role in increasing exercise and impacting on obesity levels. Improved stabilisation would have a health and safety function in high heeled shoes improving comfort and helping to prevent injuries. The flatness of the orthotic should improve wearer comfort.
Footjacks Ltd is sponsoring the trial.Subjects will be recruited from amongst the inventor’s osteopathic patients and by word of mouth from the patients and people known to the health team. The trial will take place at the inventor’s place of work in NW London.
REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/0053
Date of REC Opinion
1 Mar 2017
REC opinion
Further Information Favourable Opinion