Comparison of Exoskeleten Assisted Gait Training With End-effector Assisted Gait Training in Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- FAC
研究概览
简要总结
Aim is to compare exoskeleton assisted gait training with end-effector assisted gait training in Spinal Cord Rehabilitation
详细描述
It was planned to evaluate patients aged between 18 and 80 years who will admit to the robotic rehabilitation program due to spinal cord injury. Patients will divide into three groups as Exoskeleton, End-effector and conventional therapy. Exoskeleton and End-effector group will receive robotic therapy 4 days a week besides conventional treatment for 6 weeks. All groups will be evaluated at the start and end of the treatment.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of spinal cord injury Applying to the hospital for a rehabilitation program
排除标准
- •Inadequate body weight (obesity) Severe contractures Bone instability ( nonstable spinal cord fracture, and severe osteoporosis) Circulation problems Cardiac nonconformity Open wounds on the lower extremities or in the body where they will come into contact with the orthosis Uncoordinated, psychotic or aggressive patients Serious cognitive disorders Long-term infusion therapy Hip, knee, ankle arthrodesis Epilepsy Disproportionate limb or vertebrae, such as bone cartilage dysplasia
结局指标
主要结局
FAC
时间窗: Change from baseline FAC class to 6th week of therapy
functional ambulational classification scale
6MWT
时间窗: Change from baseline 6MWT class to 6th week of therapy
6 minute walking test
10MWT
时间窗: Change from baseline 10MWT class to 6th week of therapy
10 meter walking test
次要结局
- SCIM(Change Of SCIM from the beginnig to the 6th week of the therapy)
- ASIA(Change Of ASIA scale from the beginnig to the 6th week of the therapy)
研究者
AYLİN SARI
MD
Erenköy Physical Therapy and Rehabilitation Hospital