NCT01562652已完成不适用
AposTherapy for Singaporean Patients With Knee Osteoarthritis (OA)
Apos Medical and Sports Technology Ltd.2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年3月26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
- 60
- 试验地点
- 2
- 主要终点
- Changes in self-evaluation questionnaires between baseline and after 6 months of therapy
研究概览
简要总结
Osteoarthritis (OA) is the most prevalent form of arthritis in the elderly. It is estimated that 7% of men and 11% of women over the age of 65 have KOA. The most significant symptoms of the disease are pain and functional disability.
This study has two aims:
- To characterise the gait patterns and clinical parameters of patients with knee osteoarthritis (KOA) in Singapore at baseline, prior to treatment.
- To investigate the changes in gait patterns and the clinical benefits of treatment with a new biomechanical device, AposTherapy, for patients with KOA.
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from symptomatic bilateral knee osteoarthritis at the medial compartment for at least six months, fulfilling the ACR clinical criteria for OA of the knee, and having radiographically assessed OA of the knee according to the Kellgren and Lawrence scale.
- •Patients with an overall WOMAC score of >2cm (as measured at baseline).
- •Males and females between the ages of 50-70.
排除标准
- •Patients suffering from acute septic arthritis.
- •Patients suffering from inflammatory arthritis.
- •Patients who received a corticosteroid injection within 3 months of the study.
- •Patients suffering from avascular necrosis of the knee.
- •Patients with a history of knee buckling or recent knee injury.
- •Patients who have had a joint replacement.
- •Patients suffering from neuropathic arthropathy.
- •Patients with an increased tendency to fall.
- •Patients exhibiting a lack of physical or mental ability to perform or comply with the study procedure.
- •Patients with a history of pathological osteoporotic fracture.
- •Patients suffering from symptomatic degenerative arthritis in lower limb joints other than the knees.
- •Patients with referred pain in the knees from back or hip joint symptoms.
结局指标
主要结局
Changes in self-evaluation questionnaires between baseline and after 6 months of therapy
时间窗: Baseline, 6 months
Western Ontario and MacMaster osteoarthritis questionnaire (WOMAC) and SF-36 Health Survey will be evaluated. The WOMAC questionnaire is measured on a 10cm visual analogue scale (VAS) and the SF-36 is scored between 0-100.
次要结局
- Changes in spatio-temporal gait parameters between basline and after 6 months of therapy(Baseline, 6 months)
研究者
研究点 (2)
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