A Pilot Single-blind Randomized Controlled Trial to Evaluate the Safety and Feasibility of Rhythmic Auditory Stimulation for Gait Training in Persons With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
This study will enroll patients with Multiple Sclerosis and some difficulty with walking. The purpose of this study is to use Rhythmic Auditory Stimulation (RAS) a music therapy technique that provides rhythmic auditory cues (like a beat) to help improve a patient's movements, especially when walking.
Participants will be asked to participate in a walking program (WP) with Rhythmic Auditory Stimulation (RAS), or a WP without RAS.
详细描述
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 RAS can be delivered at a fixed tempo or interactive tempo.
The device used in this study will deliver an interactive tempo. The equipment will include a mobile device app and sensors that are attached to the participant's shoes. Headphones and smartphones will be required to use the device and will be provided to the study team and kept at the center for this study. The device is designed to use audio cues to facilitate improvements in the participant's walking speed while listening to music.
The overall purpose of this study is to assess the safety and acceptability of interactive RAS music combined with gait training in individuals with MS and walking impairment, and to gather preliminary efficacy data for future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
A blinded examiner will be used to perform the gait analysis, 6 minute walk , and timed 25 foot walk
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MS based on 2017 revised McDonald criteria (relapsing or progressive course)
- •Performs the T25FW in 8 to 30 seconds (cane(s), walking stick(s), crutch(es), or wheeled walker allowed)
排除标准
- •Physical therapy in the past 3 months or immediate need for PT due to safety concerns (e.g. falls)
- •Requires at least one seated rest during the 6 MW test
- •Treatment with high-dose corticosteroids in the past 2 months or planned during the study period
- •Lower extremity botulinum toxin (BT) injections for spasticity in the past 3 months, or planned during the study period
- •Initiation of an oral symptomatic therapy which could affect walking in the past 4 weeks (particularly dalfampridine and medications for spasticity)
- •Initiation of a new disease-modifying therapy for MS in the past 3 months
- •Comorbidity compromising safe participation or affecting walking (e.g. uncontrolled cardiac or respiratory illness, musculoskeletal disorder)
- •Severe hearing impairment with or without the use of hearing aids, such that the participant cannot hear the rhythmic music stimulus consistently.
- •Inability to walk safely to the rhythmic music stimulus during the baseline visit.
结局指标
主要结局
Number of patients with adverse events
时间窗: through study completion, up to 16 weeks
Adverse events will be collected throughout the study period to assess treatment safety.
Percentage of training sessions missed.
时间窗: through end of treatment, up to 9 weeks
Training session attendance will be tracked as an indicator of feasibility throughout the treatment period.
次要结局
- Spatiotemporal gait parameters(Week 0, Week 9 and week 16)
- MS Walking Scale - 12(Week 0, Week 9 and week 16)
- 6-Minute Walk(Week 0, Week 9 and week 16)
- Timed 25 Foot Walk(Week 0, Week 9 and week 16)
研究者
Francois Bethoux, MD
Chairman, Department of PM&R,
The Cleveland Clinic