Robot-assisted Ankle Rehabilitation for Multiple Sclerosis (Anklebot)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Strength and Gait
研究概览
简要总结
The presence of foot drop limits normal gait. Our prior data has suggested that approximately 30% of MS patients have foot drop. Although we have observed that "task-specific" rehabilitation using the Lokomat can improve ambulation in chronic MS patients, subjects with "foot drop" have difficulty translating task-specific training to normative gait patterns over ground, despite improving speed and endurance.
One of the key limitations of the Lokomat is a lack of robot-assisted training for the ankle joint. The Anklebot, an MIT-developed rehabilitation robot for the ankle, has the potential to address this. The device can move throughout three planes and train ankle flexion, extension, inversion and eversion; however, therapy with the Anklebot alone does not train the knee or hip.
We plan to test whether subject foot drop and overall gait benefit more from Anklebot therapy alone or a combination of Anklebot and Lokomat.
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.
- •Men and women between the ages 18-75 years.
- •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.
结局指标
主要结局
Strength and Gait
时间窗: 6 months
次要结局
未报告次要终点