Therapeutic Effect of Inexpensive, Flexible and Non-heeled Footwear on the Clinical, Functional and Gait Biomechanics in Elderly Women With Knee Osteoarthritis: a Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster Universities (WOMAC) Pain Subscale
研究概览
简要总结
The purpose of this study is to determine whether inexpensive, flexible and non-heeled footwear is effective in improving of clinical, functional and gait biomechanics in elderly women with knee osteoarthritis.
详细描述
- The clinical and functional aspects will be evaluated using a visual analogue scale (VAS) for pain, Western Ontario and McMaster Universities (WOMAC) and Lequesne questionnaires of quality of life in patients with knee osteoarthritis and testing of six-minute walk (6MWT).
- Biomechanical analysis of gait will be performed by infrared cameras and a force platform. From the data of kinematics and kinetics, will be calculated moments of the knee joint strength by inverse dynamics.
The process (steps) will be divided as follows:
- step 1, in this step there will be sorting and initial assessment of potential participants; pain will be evaluated through VAS, function and quality of life by means of questionnaires WOMAC and Lequesne and the 6MWT, and by evaluating the biomechanics of gait.
- step 2,(3 month follow-up), both groups will be evaluated again by the VAS and WOMAC and Lequesne questionnaires.
- step 3, after 6 months of starting the monitoring process, both groups will be reevaluated through the VAS, WOMAC, Lequesne, 6MWT and biomechanical analysis of gait. This step is the final evaluation, characterizing the end of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Kellgren and Lawrence grade 2 or 3
- •Being able to walk independently for at least 6 hours per day without the aid of canes or attendant to perform their activities of daily living
- •Knee pain between 3 and 8 on the visual analogue scale
排除标准
- •Previous history of surgery on knees, ankles and hips in the last 2 years
- •Neurological disease
- •BMI > 35 kg/m2
- •Difference in lower limb length > 1 cm
- •Prostheses and / or lower limb orthoses
- •Having received steroid injections and hyaluronic acid intra-articular knee in previous periods of three and six months respectively
- •Present at the knee joint instability (positive test results in the medial collateral ligament, lateral, anterior and posterior drawer)
- •OA of the hip and / or ankle incapacitating or diagnosed OA in lower limbs and spine
- •Inflammatory arthritis (eg. rheumatoid arthritis)
- •Asymptomatic OA of one or both knees
- •Dementia or inability to provide consistent information
- •Introduction of Nonsteroidal Anti-inflammatory Drugs and analgesic medications 8 weeks before inclusion or change of dosage of the same after the inclusion
- •Being under physiotherapy or acupuncture treatment
- •Patients with an indication of prosthesis or orthosis
- •Patients who are already using a flexible and non-heeled shoes for more than 25 hours per week (3 ½ hours per day) over the past 6 months
研究组 & 干预措施
Intervention Group
Daily use of the intervention Flexible footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women's double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25.
干预措施: Flexible footwear (Other)
Control Group
During the intervention period, patients from the Control Group (CG) were instructed not to wear Flexible footwear (Moleca®) or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost.
结局指标
主要结局
Western Ontario and McMaster Universities (WOMAC) Pain Subscale
时间窗: 6 month
The WOMAC (Western Ontario and McMaster Universities) pain subscale consists of five questions (Likert Scale) relating to the patient's pain in everyday situations. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of pain subscale ranges from 0 to 20. Higher scores indicate worse pain.
次要结局
- WOMAC Total Score(6 month)
- Paracetamol Intake(6 month)
- WOMAC Stiffness Subscale(6 month)
- First Peak of the Knee Adduction Moment (KAM) During Gait.(6 month)
- WOMAC Physical Function Subscale(6 month)
- Global Score of the Lequesne´s Questionaire Algo-functional.(6 month)
- Six-minute Walk Test(6 month)
研究者
Francis Trombini
PhD
University of Sao Paulo General Hospital