The Effect of Whole-Body Vibration Treatment Before Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Baseline leg circumference
研究概览
简要总结
The study's objective is to investigate the effects of whole-body vibration therapy administered before surgery on various factors related to patients who undergo total knee arthroplasty. These factors include pain, swelling, skin temperature, normal joint movement, knee joint position sense, knee extensor muscle strength, functional status, and patient satisfaction.
详细描述
The study will include participants aged 50-80 who are planning to undergo total knee arthroplasty. According to the sample size analysis, a total of 40 people will be included in this study. The enrolled participants will be randomly assigned to one of two parallel groups: the whole-body vibration group or the sham whole-body vibration group. Both groups will receive standard patient education and exercise training.The experimental group will receive whole-body vibration along with exercise on the whole-body vibration device, while the control group (sham group) will receive sham vibration on the same device. All participants will receive treatment for a total of 5 days, one session per day.
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)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced idiopathic knee OA and scheduled for unilateral total knee arthroplasty will be considered candidates for the present study and will be asked to participate
排除标准
- •if they had undergone another hip or knee joint replacement in the previous year
- •if they had any medical condition in which exercise was contraindicated
- •if they had any disease that affected functional performance
结局指标
主要结局
Baseline leg circumference
时间窗: baseline
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
Change in pain severity from day 7 to day 14 post-surgery
时间窗: up to 14 days after surgery
The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
Change in skin temperature from baseline to day 5 after interventions
时间窗: up to 5 days after baseline
A portable infrared thermometer will be used to measure knee skin temperature.
Change in pain severity from day 14 to day 21 post-surgery
时间窗: up to 21 days after surgery
The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
Change in leg circumference from baseline to day 5 after interventions
时间窗: up to 5 days after baseline
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
Change in the preoperative leg circumference on the 7th day of surgery
时间窗: up to 7 days after surgery
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
Change in leg circumference from day 7 to day 14 post-surgery
时间窗: up to 14 days after surgery
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
Baseline range of motion
时间窗: baseline
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
Change in range of motion from day 14 to day 21 post-surgery
时间窗: up to 21 days after surgery
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
Baseline pain severity
时间窗: baseline
The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
Change in the preoperative pain severity on the 7th day of surgery
时间窗: up to 7 days after surgery
The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
Change in leg circumference from day 14 to day 21 post-surgery
时间窗: up to 21 days after surgery
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
Change in pain severity from baseline to day 5 after interventions
时间窗: up to 5 days after baseline
The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.pain and 10 representing maximal pain.
Change in the preoperative range of motion on the 7th day of surgery
时间窗: up to 7 days after surgery
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
Change in range of motion from day 7 to day 14 post-surgery
时间窗: up to 14 days after surgery
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
Change in the preoperative muscle strength on the 7th day of surgery
时间窗: up to 7 days after surgery
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
Change in the preoperative skin temperature on the 7th day of surgery
时间窗: up to 7 days after surgery
A portable infrared thermometer will be used to measure knee skin temperature.
Change in skin temperature from day 14 to day 21 post-surgery
时间窗: up to 21 days after surgery
A portable infrared thermometer will be used to measure knee skin temperature.
Baseline knee proprioception
时间窗: baseline
Active reposition test will be measured using a digital inclinometer device.
Change in range of motion from baseline to day 5 after interventions
时间窗: up to 5 days after baseline
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
Baseline muscle strength
时间窗: baseline
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
Change in knee proprioception from day 14 to day 21 post-surgery
时间窗: up to 21 days after surgery
Active reposition test will be measured using a digital inclinometer device.
Change in muscle strength from baseline to day 5 after interventions
时间窗: up to 5 days after baseline
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
Change in muscle strength from day 7 to day 14 post-surgery
时间窗: up to 14 days after surgery
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
Change in skin temperature from day 7 to day 14 post-surgery
时间窗: up to 14 days after surgery
A portable infrared thermometer will be used to measure knee skin temperature.
Change in knee proprioception from baseline to day 5 after interventions
时间窗: up to 5 days after baseline
Active reposition test will be measured using a digital inclinometer device.
Change in the preoperative knee proprioception on the 7th day of surgery
时间窗: up to 7 days after surgery
Active reposition test will be measured using a digital inclinometer device.
Change in knee proprioception from day 7 to day 14 post-surgery
时间窗: up to 14 days after surgery
Active reposition test will be measured using a digital inclinometer device.
Change in the preoperative Time Up and Go on the 7th day of surgery
时间窗: up to 7 days after surgery
functional performance test
Change in Time Up and Go from day 7 to day 14 post-surgery
时间窗: up to 14 days after surgery
functional performance test
Change in Time Up and Go from day 14 to day 21 post-surgery
时间窗: up to 21 days after surgery
functional performance test
Change in muscle strength from day 14 to day 21 post-surgery
时间窗: up to 21 days after surgery
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
Baseline skin temperature
时间窗: baseline
A portable infrared thermometer will be used to measure knee skin temperature.
Baseline Time Up and Go
时间窗: baseline
functional performance test
Change in Time Up and Go from baseline to day 5 after interventions
时间窗: up to 5 days after baseline
functional performance test
次要结局
- Change in the preoperative WOMAC on the 21st day of surgery(up to 21 days after surgery)
- SF-36(baseline)
- Global Rating of Change Scales (GROC)(up to 21st day after surgery)
- WOMAC(before interventions, 21st day after surgery)
- Change in the preoperative SF-36 on the 21st day of surgery(up to 21 days after surgery)
研究者
Sevim Beyza Ölmez
Principal Investigator, PhD
Gazi University