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临床试验/NCT05075343
NCT05075343已完成不适用

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

Patrick Boissy4 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
4
主要终点
Foot function

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Foot function

时间窗: 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.

次要结局

  • Global and lower limb pain(up to 12 weeks)
  • Gait function(up to 12 weeks)
  • Foot pain(up to 12 weeks)
  • Orthoses wearing time(7 weeks)
  • Freeliving walking activities(up to 12 weeks)

研究者

发起方
Patrick Boissy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Patrick Boissy

Professor

Université de Sherbrooke

研究点 (4)

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