None listed
Conditions
Brief summary
This clinical trial aims to compare the effectiveness of 3D-printed medial arch support against a full-length insole for treating patients with flexible flatfoot. The primary outcomes are pain and foot function. Heel valgus angle measurement, satisfaction survey as well as foot pressure analysis are also performed. Outcomes were measured at baseline and 2, 6 and 12 weeks of intervention.
Interventions
Patients with flatfoot are randomized to receive soft and hard 3D-printed arch supports. The soft and hard medial arch supports are made of silicone materials with hardness of 35 and 70 shore OO, respectively. The patients must wear the chosen pair of shoes with silicone arch supports for the complete 12-week duration of the study. They must record wearing hours daily and being examined by a single experienced physiatrist at 2, 6 and 12-week follow-ups.
Sponsors
National Science and Technology Development Agency (NSTDA)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
flexible flatfoot with pain score between 3 to 8 for a minimum of 4 weeks. Flexible flatfoot is determined by a physiatrist using Chippaux-Smirak index.
Exclusion criteria
Those who have rigid foot deformity, a previous 1-year foot and ankle surgery, a medical history of steroid injections within the past 3 months, and other health problems associated with walking ability such as knee arthritis, diabetes, peripheral artery disease, and peripheral neuropathy are excluded.
Outcome results
None listed