Effect of Custom Foot Orthoses in Patients With Psoriatic Arthritis
Primary Purpose
Psoriatic Arthritis, Foot Arthritis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Custom foot orthoses
Sponsored by
About this trial
This is an interventional treatment trial for Psoriatic Arthritis
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.
Sites / Locations
- Centre de recherche sur le vieillissement
- Université de Sherbrooke
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Custom foot orthoses (CFO)
Arm Description
Participants with a confirmed diagnosis of PsA and foot pain received and wore custom foot orthoses (CFO).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05075343
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
August 20, 2021 (Actual)
Study Completion Date
August 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Patrick Boissy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis, Foot Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Custom foot orthoses (CFO)
Arm Type
Experimental
Arm Description
Participants with a confirmed diagnosis of PsA and foot pain received and wore custom foot orthoses (CFO).
Intervention Type
Device
Intervention Name(s)
Custom foot orthoses
Intervention Description
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.
Primary Outcome Measure Information:
Title
Foot function
Description
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.
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Foot pain
Description
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.
Time Frame
up to 12 weeks
Title
Orthoses wearing time
Description
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.
Time Frame
7 weeks
Title
Global and lower limb pain
Description
Global pain and pain at the knee, hip, and lower back pain, were measured using the NRS (0, no pain - 10, worst imaginable pain).
Time Frame
up to 12 weeks
Title
Gait function
Description
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.
Time Frame
up to 12 weeks
Title
Freeliving walking activities
Description
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.
Time Frame
up to 12 weeks
Other Pre-specified Outcome Measures:
Title
Control variables
Description
The participants were asked to record in a diary any changes in medication that occurred during the CFO intervention period.
Time Frame
7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Boissy, PhD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nathaly Gaudreault, Phd
Organizational Affiliation
Université de Sherbrooke
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pierre Dagenais, PhD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Study Director
Facility Information:
Facility Name
Centre de recherche sur le vieillissement
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4C4
Country
Canada
Facility Name
Université de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4C4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35614481
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.
Results Reference
derived
PubMed Identifier
35246222
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.
Results Reference
derived
Learn more about this trial
Effect of Custom Foot Orthoses in Patients With Psoriatic Arthritis
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