The Efficacy of Cyclic Compression Cryotherapy Combined With Phased Rehabilitation Training on Lower Limb Functional Recovery in Patients After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Knee Function Scores
研究概览
简要总结
Total knee arthroplasty (TKA) is an effective treatment for severe knee joint diseases; however, postoperative complications such as pain, swelling, and delayed functional recovery remain common challenges. Cyclic compression cryotherapy, which applies alternating cold and pressure to the knee joint, can effectively reduce swelling and alleviate pain. Meanwhile, phased rehabilitation training, tailored to the specific recovery stages post-surgery, facilitates targeted exercise interventions to promote functional restoration of the knee joint.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with knee osteoarthritis (KOA) and within 12 weeks after total knee arthroplasty (TKA).
- •Aged 18-70 years.
- •First-time unilateral TKA (non-revision surgery).
- •Physically and cognitively capable of completing required assessments.
- •Able to fully adhere to the study protocol.
- •Willing to participate in and complete the entire rehabilitation program.
- •No contraindications for surgery or postoperative rehabilitation.
- •Intact cognitive function (able to provide informed consent and follow instructions).
- •Available for all follow-up evaluations.
排除标准
- •Severe cardiovascular or cerebrovascular diseases.
- •Neuromuscular impairments affecting the lower limbs.
- •Concurrent hip or ankle joint disorders.
- •Intolerance to pain (unable to tolerate rehabilitation protocols).
- •Primary or metastatic bone tumors.
- •Rheumatoid arthritis (RA) or other systemic inflammatory arthropathies.
- •Severe obesity (BMI ≥35) or malnutrition (clinically diagnosed).
- •Inability to comply with study assessments (e.g., due to cognitive or physical limitations).
- •Visual dysfunction impairing task performance.
- •Functional impairment of the non-operated limb hindering testing/training.
- •Ankylosing spondylitis (AS).
- •History of allergic hypersensitivity to interventions used in the study.
- •Hemorrhagic predisposition (e.g., coagulation disorders, anticoagulant use).
- •Active tuberculosis or chronic myelitis.
- •History of substance dependence (e.g., opioids, alcohol).
- •Psychiatric disorders (e.g., schizophrenia, major depression).
- •Severe dysfunction of major organs (e.g., hepatic, renal, pulmonary).
研究组 & 干预措施
conventional rehabilitation treatment.
The control group underwent a 12-week conventional rehabilitation program, which primarily included muscle strength training, endurance training, proprioception training, and joint range of motion (ROM) exercises. Assessments were conducted at baseline (before treatment), as well as at 2 weeks, 6 weeks, and 12 weeks post-treatment. The evaluated outcomes included knee joint ROM, muscle strength, knee function, pain levels, and activities of daily living (ADL).
干预措施: Conventional rehabilitation treatment. (Behavioral)
Cyclic cryotherapy combined with staged rehabilitation treatment.
The experimental group received cyclic compression cryotherapy combined with phased rehabilitation training in addition to the conventional rehabilitation program, with a total intervention duration of 12 weeks.
干预措施: Phased Rehabilitation Training (Behavioral)
Cyclic cryotherapy combined with staged rehabilitation treatment.
The experimental group received cyclic compression cryotherapy combined with phased rehabilitation training in addition to the conventional rehabilitation program, with a total intervention duration of 12 weeks.
干预措施: Cyclic Compression Cryotherapy (Device)
结局指标
主要结局
Knee Function Scores
时间窗: At 6 weeks after completion of treatment.
Knee Function Scores
时间窗: At 6 weeks after completion of treatment.
次要结局
- Visual Analog Scale (VAS)(At 6 weeks after completion of treatment.)
- Range of Motion (ROM)(At 6 weeks after completion of treatment.)
- Muscle Strength(At 6 weeks after completion of treatment.)
- Activities of Daily Living (ADLs)(At 6 weeks after completion of treatment.)
- Activities of Daily Living (ADLs)(At 6 weeks after completion of treatment.)
- Range of Motion (ROM)(At 6 weeks after completion of treatment.)
- Muscle Strength(At 6 weeks after completion of treatment.)
- Visual Analog Scale (VAS)(At 6 weeks after completion of treatment.)