NCT05075343

Effect of Custom Foot Orthoses in Patients With Psoriatic Arthritis

The Effects of Custom-made Foot Orthoses on Foot Pain, Foot Function, Gait Function and Freeliving Walking Activities in Psoriatic Arthritis (PsA) Patients: A Pre-experimental Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Patrick Boissy · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Foot involvement is a major concern in psoriatic arthritis (PsA). The patients could experience severe levels of foot pain and disability and reduced mobility and quality of life. Previous studies showed that the use of Custom foot orthoses (CFO) was effective to improve foot pain and perceived disability in patients with foot disease associated with rheumatoid arthritis. However, there are no records in the literature on the effectiveness of CFO in PsA patients. Therefore, our objective was o explore the effects of CFO on foot pain, foot function, gait spatiotemporal parameters (STP), and ambulatory physical activity (APA) in PsA patients with foot involvement. In this pre-experimental exploratory study, 22 PsA patients having stable medication in the last 3 months preceding the recruitment were recruited. All the patients wore functional CFO designed by an experimented podiatrist during a 7-week period. Foot and lower limb pain and foot function were measured at baseline (T0) and after the 7-week period using the numerical rating scale (NRS) and the foot function index (FFI), respectively. Gait function was assessed by recording spatiotemporal parameters (STPs) during a 10-meter walk test using an instrumented gait analysis system (Mobility Lab) at T0 and T7. Freeliving walking activities (step count, freeliving cadence, time spent in different ambulatory physical activity (APA) intensities) at T0 and T7 were recorded over 7 days using accelerometer data collected from an instrumented sock worn by the participants during waking hours.

Conditions

• Psoriatic Arthritis
• Foot Arthritis

Interventions

Type	Name	Description
DEVICE	Custom foot orthoses	3D printed custom foot orthoses (CFO) were designed by the same experimented podiatrist based on a detailed clinical and biomechanical examination and a 3D foot scan obtained for each participant. The degrees and types were adjusted at the CFO delivery according to each patient's comfort and tolerance. The intervention period was 7weeks. The participants were taught to wear the CFO progressively during the first two weeks to allow for the lower limbs' muscles and structures to adjust to the CFO, and to wear the orthoses for the next 5 weeks, 7 days a week as often as they could.

Timeline

• Start date: 2019-07-01
• Primary completion: 2021-08-20
• Completion: 2021-08-20
• First posted: 2021-10-12
• Last updated: 2021-10-12

Locations

2 sites across 1 country: Canada