Effects of a Strengthening Program for Foot-ankle Muscles in Clinical Aspects and Gait Biomechanics of People With Knee Osteoarthritis: a Randomized Blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from baseline The WOMAC (Western Ontario and McMaster Universities) Pain Subscale at 8 and 16 weeks.
研究概览
简要总结
The main objective of this trial is To evaluate the effect of an ankle and foot muscle strengthening program on pain, analgesic consumption, functionality, and lower limb biomechanics during gait in individuals with knee osteoarthritis.
详细描述
A randomized controlled trial will be performed with 76 patients with knee osteoarthritis. The participants will be randomly assigned into either a control group (no exercises; they will keep their recommended clinical treatment) or an intervention group which will receive 8-week physical therapy exercises, three times per week, under the supervision of a physiotherapist. Every exercise has its own progression depending on the subjects' execution, increasing in intensity and difficulty.
The subjects will be evaluated in 3 different moments (Baseline, immediately after treatment and 8 weeks follow-up).
The hypothesis of this study is that the intervention group will decrease pain and medication intake, and improve functional performance, increase isometric strength of the feet and production of beneficial biomechanical changes during walking compared to the control group.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee osteoarthritis (KOA) based on clinical and radiological criteria of American College of Reumathology;
- •KOA (Grade II and III - Radiological classification of Kellgreen and Laurence) in medial compartment of knee;
- •Knee pain between 30 and 80 on the visual analogue scale;
- •BMI < 35 kg/m2.
排除标准
- •KOA isolated (Grade II and III - Radiological classification of Kellgreen and Laurence) in lateral compartment of knee;
- •Lower limb strength training (3 times per week);
- •Wear minimalist shoes for at least 6 hours a day and 5 days a week;
- •Physical therapy in the previous 3 months;
- •Having received steroid injections and hyaluronic acid intra-articular knee in previous periods of three and six months respectively;
- •Previous history of surgery on knees, ankles and hips in the last 2 years;
- •Neurological disease;
- •Inflammatory arthritis (eg. rheumatoid arthritis);
- •Asymptomatic OA of one or both knees.
结局指标
主要结局
Change from baseline The WOMAC (Western Ontario and McMaster Universities) Pain Subscale at 8 and 16 weeks.
时间窗: Baseline, 8 weeks and 16 weeks.
The WOMAC 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
- 30-second Chair Stand Test(Baseline, 8 weeks and 16 weeks.)
- 9-step Stair Climb Test(Baseline, 8 weeks and 16 weeks.)
- Foot strength(Baseline, 8 weeks and 16 weeks.)
- Foot Kinematics during gait(Baseline, 8 weeks and 16 weeks.)
- Paracetamol intake(Baseline, 8 weeks and 16 weeks.)
- Change from baseline WOMAC (Western Ontario and McMaster Universities) Stiffness Subscale at 8 and 16 weeks.(Baseline, 8 weeks and 16 weeks.)
- Change from baseline WOMAC (Western Ontario and McMaster Universities) Physical Function Subscale at 8 and 16 weeks.(Baseline, 8 weeks and 16 weeks.)
- Change from baseline WOMAC (Western Ontario and McMaster Universities) Total Score at 8 and 16 weeks(Baseline, 8 weeks and 16 weeks.)
- 40m (4x10m) Fast Paced Walk Test(Baseline, 8 weeks and 16 weeks.)
- Knee joint moments during gait(Baseline, 8 weeks and 16 weeks.)
- Global Rating of Change Scale(8 weeks and 16 weeks.)
研究者
Glauko André de Figueiredo Dantas
Principal Investigator (MSc)
Universidade Federal de Sao Carlos