Clinical trial NCT05075343: Effect of Custom Foot Orthoses in Patients With Psoriatic Arthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriatic Arthritis
Foot Arthritis
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Foot function
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Foot pain
timeFrame: up to 12 weeks
measure: Orthoses wearing time
timeFrame: 7 weeks
measure: Global and lower limb pain
timeFrame: up to 12 weeks
measure: Gait function
timeFrame: up to 12 weeks
measure: Freeliving walking activities
timeFrame: up to 12 weeks
Other outcomes:
measure: Control variables
timeFrame: 7 weeks
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche sur le vieillissement
state: Quebec
city: Sherbrooke
country: Canada
facility: Université de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Patrick Boissy, PhD
role: STUDY_DIRECTOR
affiliation: Université de Sherbrooke
name: Nathaly Gaudreault, Phd
role: STUDY_DIRECTOR
affiliation: Université de Sherbrooke
name: Pierre Dagenais, PhD
role: STUDY_DIRECTOR
References:
citation: Walha R, Dagenais P, Gaudreault N, Beaudoin-Cote G, Boissy P. The effects of custom-made foot orthoses on foot pain, foot function, gait function, and free-living walking activities in people with psoriatic arthritis (PsA): a pre-experimental trial. Arthritis Res Ther. 2022 May 25;24(1):124. doi: 10.1186/s13075-022-02808-8.
citation: Walha R, Gaudreault N, Dagenais P, Boissy P. Spatiotemporal parameters and gait variability in people with psoriatic arthritis (PsA): a cross-sectional study. J Foot Ankle Res. 2022 Mar 4;15(1):19. doi: 10.1186/s13047-022-00521-y.