Effect of Custom Foot Orthoses in Patients With Psoriatic Arthritis

Not Applicable

Completed

• Conditions: Psoriatic Arthritis; Foot Arthritis
• Interventions: Device: Custom foot orthoses

• Registration Number: NCT05075343
• Lead Sponsor: Patrick Boissy

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2021-08-20
• Study Completion: 2021-08-20
• Status Verified: 2021-09
• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-09-29
• Last Update Submitted: 2021-09-29
• Study First Posted: 2021-10-12
• Last Update Posted: 2021-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Aged between 20 and 70 years
• Diagnosed with psoriatic arthritis by a rheumatologist
• Having moderate to severe foot pain scored at least 3 on the numeric rating scale
• Having stable medication for the three months preceding the study

Exclusion Criteria

• Having diabetes or neurological disease that may affect the feet
• Having recent traumatic foot injury
• Having received specific interventions for the feet (ex: foot orthoses, orthopedic shoes, intraarticular steroid injection) for the three months preceding the study.
• Having a recent history of foot surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Custom foot orthoses (CFO)	Custom foot orthoses	Participants with a confirmed diagnosis of PsA and foot pain received and wore custom foot orthoses (CFO).

Primary Outcome Measures

Name	Time	Method
Foot function	up to 12 weeks	Foot function was measure using the Foot function index (FFI). The FFI is a self-reported questionnaire composed of 23 items divided into three subscales measuring foot pain (FFI-P), foot disability (FFI-D) and foot-related activity limitation (FFI-AL). Each item of The FFI was recorded on a NRS (0 to 10) allowing for the calculation of both, total and subscale scores. The values range between 0 and 100, with higher values indicating greater pain, disability, and activity limitation.

Secondary Outcome Measures

Name	Time	Method
Global and lower limb pain	up to 12 weeks	Global pain and pain at the knee, hip, and lower back pain, were measured using the NRS (0, no pain - 10, worst imaginable pain).
Gait function	up to 12 weeks	Gait function was assessed using an instrumented gait analysis system. Gait spatiotemporal parameters (STPs) including cadence, gait cycle duration, gait speed, stride length, double support, swing time, foot strike angle, and stride time variability, were recorded using the Mobility Lab system (APDM Wearable Technologies) during 10 meters walk test (10MWT). Mobility Lab is research grade system that has been proven to be accurate and reliable in estimating STP. Mobility Lab uses a set of six OPAL inertial measurement units (IMUs) and a software that allows for an automated and easy extraction of STP. All the participants performed three 10MWT trials over a 14-meters straight walkway with the Mobility lab's IMUs fixed with elastics straps on the chest, the lower back and both wrists and feet. The walks were performed at the participants' comfortable speed and the average of the three trials was calculated.
Foot pain	up to 12 weeks	The intensity of foot pain was measured using a zero-to-ten numeric rating scale (NRS). Participants were asked to circle a number between 0 and 10 that fits best their average pain intensity at the foot in the seven days preceding data collection. Foot pain was assessed more in details (e.g. pain at walking with foot orthoses, pain at walking with shoes, pain at the end of the day etc.) with the pain sub-scale of the foot function index (FFI). Moreover, to monitor the evolution of weekly foot pain intensity during the intervention period, the patients were asked to record at the end of each week, the intensity of foot pain in a diary using 0 to 10 NRS.
Orthoses wearing time	7 weeks	Orthoses wearing time was assessed by asking the participants to record in a diary that included a calendar covering the 7-week intervention period, the daily wearing time in hours. The CFO wearing time is reported as the average wearing time per week.
Freeliving walking activities	up to 12 weeks	Freeliving walking activities including step count, freeliving cadence, and time spent in ambulatory physical activity (APA) intensity-based categories were assessed using an instrumented sock (Sensoria Inc, Redmond, WA, USA) with an embedded 9 axis IMU positioned at the ankle. The instrumented sock connects automatically, without any manipulation needed from the participants, via Bluetooth to a smartwatch (Apple Watch, series 3) where the raw inertial measures of motion (3D accelerometer) are stored and then transferred to a PC for data reduction and processing to extract gait activities specific outcomes.

Trial Locations

Locations (2)

Université de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

Centre de recherche sur le vieillissement; 🇨🇦 Sherbrooke, Quebec, Canada