The Effects of Robot-assisted Gait Training on Locomotor Function and Motor Unit Firing in Multiple Sclerosis Subjects With Severe Gait Impairments. A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- motor unit firing rate characteristics
研究概览
简要总结
Aims of the study:
This is a randomized-controlled trial to test the effects of robot-assisted gait training on locomotor function and motor unit firing rate in multiple sclerosis subjects with severe gait impairments. The control group will be treat with conventional physical therapy.
Subjects and methods:
60 multiple sclerosis patients will be recruited in two outpatient rehabilitation clinics.
Informed consent will be obtained. Participants will be randomized to Robot-assisted gait training (experimental group) or conventional therapy (control group) through a randomization stratification approach, according to a block randomization of 4.
The experimental group will receive 12 robot-assisted gait training sessions over 6 weeks (2 sessions/week). The control group will receive 12 conventional therapy sessions over 6 weeks (2 sessions/week), that will focus on gait training.
Primary outcome measures will be both neurophysiological measures (motor unit firing rate characteristics) and clinical test for gait speed (10m walking test). Secondary outcome measures will include: clinical tests of walking endurance (six minute walking test), balance (Berg Balance Test) and mobility (Up and Go Test).
Clinical assessment of lower-extremities spasticity (Modified Ashworth Scale), motor fatigue (Fatigue Severity Scale), depression (PHQ-9) and quality of life (SF-36) will be monitored. Subject acceptance and confidence in the treatments will be track with a Visual Analog Scale. Outcome measures will be assessed the week prior to treatment initiation (T0), after 6 sessions (T1), the week after the end of treatment (T2) and at 3 months follow-up (T3) to evaluate treatments retention, by a clinician blinded to 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
- 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
- •males and females, community dwelling, age 18 or older
- •diagnosis of multiple sclerosis in a stable phase, with relapses > 6 months prior to study enrollment
- •moderate to severe gait impairments referred to Expanded Disability Status Scale (EDSS) between 6 and 7
排除标准
- •neurologic conditions in addition to multiple sclerosis that may affect motor function
- •medical conditions likely to interfere with the ability to safely complete the study
- •impaired cognitive functioning: Mini Mental Status Examination < 24
- •severe lower-extremities spasticity or contractures that may limit range of motion(Ashworth score >4 for hip, knee or ankle flexors/extensors
结局指标
主要结局
motor unit firing rate characteristics
时间窗: 12 months
It will be performed through the analysis of superficial EMG signals during isometric knee extension.
次要结局
- quality of life(12 months)
- walking endurance(12 months)
- gait speed(12 months)
- mobility(12 months)
- balance(12 months)
- Fatigue(12 months)
- depression(12 months)
研究者
Sofia Straudi, MD
MD
University Hospital of Ferrara