Major CIHR grant for multicenter study on foot orthotics
Cirris is proud to announce that it has been awarded a major five-year grant of $715,275 from the Canadian Institutes of Health Research (CIHR) to conduct a randomized controlled multicenter trial on the effects of prefabricated and custom-made foot orthotics in the treatment of posterior tibial tendon dysfunction.
The result of close collaboration between the Neuromusculoskeletal Disorders Research Group (GRAN) at the Université du Québec à Trois-Rivières (UQTR) and Cirris, the project is fully in line with an interdisciplinary and translational approach to rehabilitation research.
The research team includes several co-researchers with complementary expertise: Gabriel Moisan (UQTR and Cirris), Jacques Abboud (UQTR), Virginie Blanchette (UQTR), Jean-Sébastien Roy (ULaval and Cirris), Pier-Luc Isabelle, Dominic Chicoine, and Logananda Boodadoo. Together, they will contribute to the implementation and success of this multicenter study, which will strengthen scientific knowledge and support the improvement of interventions offered to people living with musculoskeletal disorders.
About the project
Posterior tibial tendon dysfunction (PTTD) is a chronic, degenerative musculoskeletal condition that manifests as progressive foot and ankle drop. It causes persistent pain, significant functional limitations, and a marked decrease in quality of life. Without early and effective intervention, PPMTD can become irreversible and lead to costly surgical treatments, often associated with a long and complex recovery period.
Foot orthotics are a key component of conservative management of TTPD. By more finely correcting the biomechanical and functional deficits associated with this condition, custom foot orthotics appear to be a particularly promising option for reducing pain, improving function, and slowing the progression of the condition, compared to prefabricated orthotics. However, their clinical effects remain insufficiently documented, which limits the optimization of interventions offered to patients.
It is in this context that this project aims to conduct a randomized controlled superiority trial, multicenter, parallel-group, double-blind, to compare the effectiveness of adding custom foot orthotics to basic treatment with that of adding prefabricated foot orthotics. The study will evaluate their short- and medium-term effects on pain severity and foot function in people with chronic TTPD. The central hypothesis is that custom orthotics, combined with basic treatment, will result in greater pain reduction and superior improvement in foot function than prefabricated orthotics.
A total of 198 participants will be recruited and randomized into three groups: (1) basic treatment combined with placebo foot orthotics offering minimal support, (2) basic treatment combined with prefabricated foot orthotics, and (3) basic treatment combined with custom foot orthotics. Basic treatment will include a program of stretching and strengthening exercises for the ankle muscles, as well as education focused on managing mechanical stress on injured structures. The primary outcome measure will be pain severity, while secondary outcome measures will include foot function and limitations, lower limb biomechanics during walking, quality of life, satisfaction with treatment, and muscle strength. Participants will be assessed at the time of orthotic delivery and then at 12, 24, and 52 weeks.
The research team brings together all the expertise required to carry out this project, including podiatric medicine, rehabilitation, orthotic therapy, biomechanics, and the conduct of multicenter randomized controlled trials. Composed of researchers, clinicians, and an orthotist, it builds on previous work that has already demonstrated the effectiveness of custom foot orthotics in improving foot and ankle biomechanics in people with DTTP.
The expected results of this clinical trial will provide essential evidence to support clinical decision-making and improve interventions for people living with DTTP. They will contribute to the evolution of professional practices and may be incorporated into clinical guidelines for the management of this condition.