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Psoriatic ArthritisNCT05075343

Effect of Custom Foot Orthoses in Patients With Psoriatic Arthritis

A study testing Custom foot orthoses in people with Psoriatic Arthritis and Foot Arthritis, run by Patrick Boissy at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Psoriatic Arthritis, Foot Arthritis
What is being tested?
Custom foot orthoses
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
2 sitesCanada
Study dates
1 Jul 2019to 20 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Centre de recherche sur le vieillissement

    Sherbrooke, Quebec, J1H 4C4

  • Université de Sherbrooke

    Sherbrooke, Quebec, J1H 4C4

Other trials in Canada

About this study

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

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.

Being tested
Custom foot orthoses
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Custom foot orthosesDevice

    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.

Study groups in NCT05075343
Study groupRoleWhat they receive
Custom foot orthoses (CFO)ExperimentalParticipants with a confirmed diagnosis of PsA and foot pain received and wore custom foot orthoses (CFO).
Receives: Device: Custom foot orthoses

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Foot function

    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.

    Measured: up to 12 weeks

Secondary outcomes (5)

  1. Foot pain

    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.

    Measured: up to 12 weeks

  2. Orthoses wearing time

    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.

    Measured: 7 weeks

  3. Global and lower limb pain

    Global pain and pain at the knee, hip, and lower back pain, were measured using the NRS (0, no pain - 10, worst imaginable pain).

    Measured: up to 12 weeks

  4. Gait function

    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.

    Measured: up to 12 weeks

  5. Freeliving walking activities

    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.

    Measured: up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2021
  2. Study start1 Jul 2019
  3. Primary completion20 Aug 2021
  4. Study completion20 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05075343
Sponsor's protocol ID
2020-3182
Status last verified
Sep 2021
First submitted
20 Sep 2021
Last updated
12 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35614481

  • 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.

    PubMed 35246222

Questions about this trial

What is this clinical trial studying?

A study testing Custom foot orthoses in people with Psoriatic Arthritis and Foot Arthritis, run by Patrick Boissy at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Foot function (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05075343, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.

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