To Estimate the Efficacy of Botulinum Toxin a Injection Combing with Exoskeleton Robotic Assisted Gait Training in Stroke Patients with Spastic Stiff Knee Gait: Motor Function Performance and Neurophysiological Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Modified Emory Functional Ambulation Profile(mEFAP)
研究概览
简要总结
The purpose of this project is to examine and compare the immediate and long-term effects of combined Botulinum toxin type A(BoNT-A) injection with exoskeleton Robotic assisted gait training (RABT) in patients with post-stroke stiff-knee gait.
详细描述
The aim of the study is to evaluate the effects of BoNT-A combining with overground exoskeleton robot for patients with post-stroke stiff-knee gait.
Stiff-knee gait (SKG) is a common gait pattern in patients after stroke, characterized by limited knee flexion (KF) during the swing phase of walking. Botulinum toxin A (BoNT-A) injection in rectus femoris muscle is considered the gold standard procedure to treat SKG.
Patients with this gait pattern would reduce walking speed, cause toe dragging, compromise the stability of walking, increase risk of falling, and interfere with daily activities. This randomized controlled trial will contribute to the accelerated refinement and development of efficient and effective treatment programs for patients with post-stroke spastic stiff knee gait. The Robot-assisted gait training (RAGT) has the potential to be an optimal adjunctive therapy following BoNT-A treatment. Combinations of BoNT-A and rehabilitation training are suggested to optimize the treatment effect for spasticity related disabilities.
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
- Single (Participant)
盲法说明
There will be a research code representing patients' identity, this code will not show patients' name, social security number, and home address. For the results of patients' visit and the diagnosis, the study moderator will maintain a confidential attitude and be careful to maintain patients' privacy.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic or hemorrhagic stroke ≥ 3 months
- •Age ≥ 20 years
- •Functional Ambulation Category ≥4
- •Affected rectus femoris spasticity (MAS between 1+ and 2)
- •BoNT-A treatment-naive or treated with BoNT-A ≥4 months in the affected leg before recruitment
- •Receiving oral muscle relaxants or other medication for spasticity were on a stable dose for≥2 months
- •Can obey simple order
排除标准
- •Sensitivity to BoNT-A
- •Infection of the skin, soft tissue in the injection area
- •Participation in other trials
- •Fixed contractures or bony deformities in the affected leg
- •Previous treatment of the affected leg with neurolytic or surgical procedures (i.e., phenol block, tendon lengthening of transfer, tenotomy, muscle release, arthrodesis)
- •Severe cardiovascular comorbidity (i.e., recent myocardial infarction, heart failure, uncontrolled hypertension, orthostatic hypotension)
结局指标
主要结局
Modified Emory Functional Ambulation Profile(mEFAP)
时间窗: Change from baseline at 5 months
The mEFAP is a clinical test that measures the time to ambulate through five common environmental terrains with or without an assistive device .It has been demonstrated to have a high inter-rater and test-retest reliability as a measure of gait capacity and functional ambulation in the post stroke patient population. The mEFAP comprises five timed tasks: (1) a 5-m walk on a hard floor; (2) a 5-m walk on a carpeted surface; (3) to rise from a chair, a 3-m walk, and return to a seated position (the timed "up-and-go" test); (4) a standardized obstacle course; and (5) to ascent and descent five stairs. The five timed sub scores will be adjusted by a multiplier for any necessary assistive device and then add together to derive a composite score.
次要结局
- Modified Ashworth scale(Change from baseline at 5 months)
- Pendulum test(Change from baseline at 5 months)
- Isometric strength(Change from baseline at 5 months)
- Medical Research Council scale(Change from baseline at 5 months)
- Berg Balance Scale(Change from baseline at 5 months)
- Six-Minute Walking Test(Change from baseline at 5 months)