NCT00872053已完成1 期
Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Ankle accuracy and stiffness
研究概览
简要总结
The primary aim of this study is to:
- Collect pilot data on the effect of task-specific lower extremity training using the Anklebot on subjects with Multiple Sclerosis (MS) and who have foot drop;
- Collect pilot data on the use of combination therapy on improving gait in subjects with MS. This therapy will use both Anklebot training and robot-assisted gait training.
Hypothesis: Both trainings will result in improved walking performance, but the combination therapy will result in greater gains than ankle training alone.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of MS by McDonald criteria (McDonald, Compston et al. 2001). EDSS level between 3.5-5.5, who report ambulation problems.
- •Presence of unilateral foot drop that is clinically apparent to the PI or PI designate.
- •Must be able to ambulate 25 feet without an assisting device.
排除标准
- •Cardiovascular: recent MI < 4 wk, uncontrolled HTN >190/110 mmHg.
- •History of uncontrolled diabetes.
- •Symptoms of orthostasis when standing up.
- •Circulatory problems, history of vascular claudication or pitting edema.
- •Unable to fully understand instructions in order to use the equipment or the process of the study.
- •Body weight over 150 kg.
- •Lower extremity injuries that limit range of motion or function.
- •Joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment.
- •Unstable fractures.
- •Pressure sores with any skin breakdown in areas in contact with the body harness or Lokomat apparatus.
- •Chronic and ongoing alcohol or drug abuse.
- •Pre-morbid, ongoing depression or psychosis.
- •Ongoing physical therapy.
- •Pregnancy (self-reported)
- •PI's determination of inability to complete the test protocol
研究组 & 干预措施
Arm 1
Experimental
Focused Ankle Training
干预措施: Anklebot (Device)
Arm 2
Experimental
Combination Therapy
干预措施: Anklebot (Device)
Arm 2
Experimental
Combination Therapy
干预措施: Lokomat (Device)
结局指标
主要结局
Ankle accuracy and stiffness
时间窗: At inclusion, after 8 sessions, after 16 sessions
次要结局
- Gait assessments (e.g., 6-Minute Walk, Timed 25-Foot Walk)(At inclusion, after every 4 sessions)
- Functional assessments (EDSS, MS Functional Composite)(At inclusion, after 8 sessions, after 16 sessions)
研究者
研究点 (1)
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