Effect of Custom Foot Orthoses in Patients With Psoriatic Arthritis
NCT ID: NCT05075343
Last Updated: 2021-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2019-07-01
2021-08-20
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Custom foot orthoses (CFO)
Participants with a confirmed diagnosis of PsA and foot pain received and wore custom foot orthoses (CFO).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
20 Years
70 Years
ALL
Yes
Sponsors
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Patrick Boissy
OTHER
Responsible Party
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Patrick Boissy
Professor
Principal Investigators
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Patrick Boissy, PhD
Role: STUDY_DIRECTOR
Université de Sherbrooke
Nathaly Gaudreault, Phd
Role: STUDY_DIRECTOR
Université de Sherbrooke
Pierre Dagenais, PhD
Role: STUDY_DIRECTOR
Université de Sherbrooke
Locations
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Centre de recherche sur le vieillissement
Sherbrooke, Quebec, Canada
Université de Sherbrooke
Sherbrooke, Quebec, Canada
Countries
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References
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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.
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.
Other Identifiers
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2020-3182
Identifier Type: -
Identifier Source: org_study_id