Supported Treadmill Ambulation Training (STAT) for Patients Diagnosed With Amyotrophic Lateral Aclerosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Twenty Five Foot Walk Test (25FWT)
研究概览
简要总结
The purpose of this study is to find out if supervised exercise training using a treadmill with partial weight support is safe and has an impact on gait and function of persons with Amyotrophic lateral sclerosis.
详细描述
Twenty ALS patients who are independent in their transfer with assistive devise such as walker, cane, or AFO will be offered the opportunity to participate in this study. 20 subjects will be enrolled at Carolinas ALS/Neuromuscular Center at the Carolinas HealthCare System. Eligible subjects will return for 26 sessions, each lasting between 1-2 hours. At Session 1 (4 weeks pre-treatment), assessments of muscle strength, spasticity, gait, and balance will be performed, which will take between 30-60 minutes. At Sessions 2-25, patients will do supported treadmill ambulation training at a very low speed 3 times a week for 6 weeks under the supervision of the physical therapist. Each session will have 30 minutes of direct ambulation with the suspension system and treadmill over a 60 minute period of time. Additionally, at sessions 13 and 26 (4 and 8 weeks post-treatment), the assessments of muscle strength, spasticity, gait, and balance will be repeated. Needle EMG to assess denervation potential will be performed at base line and at the conclusion of the study. The study will last a total of 26 weeks for each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically probable or definite diagnosis of ALS/MND
- •Able to stand independently and ambulate for six minutes with their assistive devices
- •Able to complete the 25 foot walk in less than 1 minute
- •Vital Capacity of over 65% predicted
- •25 to 75 years of age
- •Not a pregnant woman
- •Able to provide informed consent and to comply with training and assessment procedures
排除标准
- •Unstable angina or severe left main coronary disease
- •End-stage congestive heart failure
- •Severe valvular heart disease
- •Malignant or unstable arrhythmias
- •Elevated resting blood pressure (systolic, 200mmHg; diastolic, 110mmHg)
- •Large or expanding aortic aneurysm
- •Known cerebral aneurysm or recent intracranial bleed
- •Uncontrolled or end-stage systemic disease
- •Acute retinal hemorrhage or recent ophthalmologic surgery
- •Acute or unstable musculoskeletal injury
结局指标
主要结局
Twenty Five Foot Walk Test (25FWT)
时间窗: baseline, after 4 weaks and 8 weaks post training
The Six-Minute Walk Test (6MWT)
时间窗: baseline, after 4 weaks and 8 weaks post training
Fatigue severity scale (FSS)
时间窗: baseline, after 4 weaks and 8 weaks post training
次要结局
- Muscle strength(baseline, after 4 weaks and 8 weaks post training)
- ALS functional rating scale (ALSFRS-R)(baseline, after 4 weaks and 8 weaks post training)
- Vital Capacity(baseline, after 4 weaks and 8 weaks post training)
- Beck Depression Inventory (BDI)(baseline, after 4 weaks and 8 weaks post training)