Effect of Antigravity Treadmill Training on Pain, Gait Characteristics, and Function in Patients With Knee Osteoarthritis- A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Assessment of patient pain
研究概览
简要总结
To date, the anti-gravity treadmill, as a representative method of lower body positive pressure treadmills, has been rarely reported for knee osteoarthritis rehabilitation.
Purpose: This study aims to evaluate the effect of antigravity treadmill training on pain, gait characteristics, and function in patients with knee osteoarthritis.
详细描述
The study included 40 patients with knee osteoarthritis who were randomly assigned to one of two groups: the antigravity treadmill group (n=20) or the control group (n=20 ). For 12 weeks, the antigravity treadmill group received training on the Alter G treadmill (75% weight-bearing, 30 minutes per session, three times per week) combined with traditional physical therapy. During the same period, the control group received only traditional physical therapy. The Visual Analogue Scale, Walkway System, and the Western Ontario and McMaster Universities Arthritis Index were used to assess pain, spatiotemporal gait parameters, and patient function, respectively. All outcome measures were obtained pretreatment, post-treatment, and 3 months follow-up assessment.
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 (Participant, Outcomes Assessor)
盲法说明
Patients were randomly assigned to either the antigravity treadmill group (n = 20) or the control group (n = 20 ) using an online randomization website (www.randomization.com). The control group received a conventional physical therapy program. The therapists responsible for measuring and assessing the outcomes remained blinded to the group assignments.
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
- 是
入选标准
- •Patients should: (1) be ≥50 years old
- •Patients have been diagnosed with mild to moderate osteoarthritis by a physician and confirmed by radiograph imaging (Kellgren & Lawrence grade 1-3)
- •Patients complain of knee pain during the past 30 days when walking, squatting, and/or kneeling (the minimum level 3/10 on visual analogue scale before inclusion)
- •Patients' body mass index greater than
- •Exclusion criteria
- •Patients were excluded if they have a history of ankle, knee, or hip injury or medical operation
- •Have used knee injection for their knee osteoarthritis pain within the past year
- •Have a history of other medical conditions that would interfere with walking
- •Received physical therapy during the past 3 months for knee osteoarthritis
- •Had any metabolic, pulmonary, neuromuscular, neurological, and/or autoimmune disease.
排除标准
- 未提供
结局指标
主要结局
Assessment of patient pain
时间窗: Pre and post 3 months intervention period
The visual analogue scale is a reliable, valid, responsive, and frequently used pain outcome measure. It consists of a bidirectional 10 cm straight line with two labels, that is, "no pain" and "worst possible pain", located at either end of the line. Patients are instructed to draw a vertical mark on the line indicating their pain level.
Evaluation of gait parameters (step length)
时间窗: Pre and post 3 months intervention period
Gait parameters were measured using walkway System. The researcher assessed step length in centimeters
Evaluation of gait parameters (velocity)
时间窗: Pre and post 3 months intervention period
Gait parameters were measured using walkway System. The researcher assessed velocity which is measured in centimeter/second
Evaluation of patient function
时间窗: Pre and post 3 months intervention period
The Western Ontario and McMaster Universities Arthritis Index was used for assessing activities of daily living, functional mobility, gait, general health, and quality of life in patients with knee osteoarthritis. It has a total of 24 items and three subscales, namely pain (5 items), stiffness (2 items), and function (17 items), scored on a five-point ordinal scale, 0 - none, 1 - mild, 2 - moderate, 3 - severe, and 4 - extremely severe. Higher scores indicate worse pain, stiffness, and functional limitations.
Evaluation of gait parameters (step time)
时间窗: Pre and post 3 months intervention period
Gait parameters were measured using walkway System. The researcher assessed step time in seconds
次要结局
未报告次要终点