NCT01689922终止不适用
The Effectiveness of Anti-Gravity Treadmill Training in Patients After Lumbar Microdiscectomy and Fusion Surgeries
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Oswestry Disability Questionnaire
研究概览
简要总结
The primary objective of this study is to compare the effectiveness of standard for our practice postoperative physical therapy (PT) program to a PT program that incorporates lower body positive pressure (LBPP) treadmill training for the patients after lumbar discectomy and fusion surgeries.
详细描述
A prospective, randomized, parallel group controlled clinical study is proposed. The patients will be divided into the two study groups according to the surgical procedure:
- patients undergoing one-level microdiscectomy for lumbar herniated disc
- patients undergoing one-level lumbar fusion for degenerative disc disease without notable spinal stenosis.
Each group will consist of 60 patients (see sample size calculations below) who will be randomized into the two equal groups to undergo:
- Standard postoperative rehabilitation program
- Standard postoperative rehabilitation program with addition of lower body positive pressure (LBPP) treadmill training
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 18 and 65 years old
- •Willing and able to comply with protocol and PT requirements
- •Patients with primarily radicular and back pain due to degenerative disc disease requiring one-level discectomy for herniated disc or lumbar fusion between L2 and S1
- •Willing and able to sign a study specific informed consent
排除标准
- •Require more than one-level surgery
- •No previous lumbar surgery
- •Any ongoing health condition that would make it difficult to adhere to postoperative PT requirements
- •Peri-operative or post-operative complications (infection, pneumonia, nerve injury, dural tear, etc.) that would constraint or delay the ability to participate in postoperative PT
- •BMI greater than 40
- •Active local or systemic infection
结局指标
主要结局
Oswestry Disability Questionnaire
时间窗: 24 months
10 points or 20% improvement on Oswestry Disability Questionnaire
次要结局
- Patient Global Outcome Ratings and Health Quality Improvement(24 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Anti-gravity Treadmill Training in Patients With Knee OsteoarthritisKnee OsteoarthritisNCT05319964Gaziler Physical Medicine and Rehabilitation Education and Research Hospital30
已完成
不适用
Anti-gravity Treadmill Exercise in Stress Myocardial Perfusion ImagingCoronary Artery DiseaseNCT02628002University of Cincinnati49
招募中
不适用
The Effect of Anti-Gravity Treadmill Training in Patients With Meniscus TearsMeniscus TearNCT06646536Bezmialem Vakif University48
已完成
不适用
Effectiveness of Antigravity Treadmill Training in improving Walking Capacity and Balance in Hemiparetic Ischemic Stroke PatientsSubacute ischemic hemiparetic stroke patients with impair gait functionantigravity treadmillwalking capacitybalancestrokeTCTR20160601005Physical medicine and rehabilitation department,faculty of medicine Chulalongkorn university34
已完成
不适用
The Effectiveness of Body Weight Supported Treadmill Training in Stroke PatientsCerebrovascular AccidentGait Disorders, NeurologicWalking, DifficultyStrokeNCT04597658Istanbul University30