Effects of a Home Based Walking Program Using Rhythmic Auditory Stimulation on Walking and Cortical Activation in Patients With Multiple Sclerosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Improved gait pattern on gait analysis
研究概览
简要总结
Rhythmic Auditory Stimulation (RAS) is a music therapy technique that provides rhythmic auditory cues (like a beat) to help improve patients' movements, especially when walking.
The purpose of this study is to compare the effect on walking performance of a home based walking program (HBWP) with Rhythmic Auditory Stimulation (RAS), to that of a HBWP without RAS, or to RAS without walking exercise.
A second part of this study will assess the effects of Rhythmic Auditory Stimulation (RAS) on brain activity in patients with Multiple Sclerosis while performing mental imagery of walking.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 years or older
- •diagnosis of MS per Mc Donald criteria
- •Ambulation Index score from 2 to 6 inclusive (clinically observable gait disturbance, whether the subject walks with no, unilateral, or bilateral support)
- •spastic paresis is the main neurologic impairment causing the gait disturbance, per investigator's judgment.
排除标准
- •neurologic impairments other than spastic paresis (e.g. cerebellar ataxia or sensory ataxia), or non-neurologic impairments (e.g. musculoskeletal problems) play a major role in the subject's gait disturbance, per investigator's judgment;
- •treatment for an MS exacerbation in the past 30 days;
- •severe co morbidity precluding participation in the study per investigator's judgment (e.g. severe cardiac or respiratory failure);
- •severe cognitive deficits precluding informed consent or preventing the subject from following study procedures safely
- •contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
研究组 & 干预措施
Walking-Rhythmic Auditory Stimulation
Walking daily with Rhythmic Auditory Stimulation (RAS) based music for 4 weeks
干预措施: Rhythmic Auditory Stimulation (RAS) (Other)
Walking- only
Walking daily with no Rhythmic Auditory Stimulation (RAS) based music for 4 weeks
干预措施: Rhythmic Auditory Stimulation (RAS) (Other)
Rhythmic Auditory Stimulation (RAS)only
Listening to based music only daily for 4 weeks
干预措施: Rhythmic Auditory Stimulation (RAS) (Other)
结局指标
主要结局
Improved gait pattern on gait analysis
时间窗: 8 weeks
To compare the effect on gait pattern of a walking program with Rhythmic Auditory Stimulation, to that of a walking program without Rhythmic Auditory Stimulation, or Rhythmic Auditory Stimulation without walking exercise.
次要结局
- Improved walk time on the timed 25 foot walk test(8 weeks)
- Improved distance on the 2 minute walk test(8 weeks)