Feasibility and Preliminary Effects of Using a Music-based, Rhythm-modulating Wearable Sensor System in the Community in Persons With Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Usability (Feasibility) Based on Participant Ratings on Acceptability and Usability Questionnaire.
研究概览
简要总结
The purpose of this clinical study is to evaluate the effects of music, tailored to the participant's cadence, on adherence, quality of life, gait speed, functional mobility, and walking activity in individuals with Parkinson disease when used in the home and community environment.
详细描述
Persons with Parkinson disease will be enrolled to determine the effects of a community walking program with a music-based device on adherence, quality of life, walking speed and walking activity. The walking program will be carried out independently by participants in their home/community environment. Noninvasive functional assessments commonly administered in clinical practice will be used to measure the variables of interest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of idiopathic, typical Parkinson disease.
- •Modified Hoehn and Yahr stages 1-3 per physical exam.
- •Able to walk independently without physical assistance or an assistive device.
排除标准
- •Diagnosis of atypical Parkinsonism.
- •Moderately or significantly disturbing freezing episodes during daily walking.
- •Cognitive impairment as determined by the Montreal Cognitive Assessment (MoCA).
- •Significant hearing impairment.
- •Currently participating in physical therapy.
- •Cardiac problems that interfere with the ability to safely exercise.
- •Orthopedic problems in the lower extremities or spine that may limit walking distance.
结局指标
主要结局
Usability (Feasibility) Based on Participant Ratings on Acceptability and Usability Questionnaire.
时间窗: 28 days
Usability as assessed by participant ratings on Acceptability and Usability Questionnaire. The Questionnaire is comprised of adapted items from the System Usability Scale, Post Study System Usability Questionnaire, Technology Assessment Model Measurement Scales, and Usefulness, Satisfaction, and Ease questionnaire as described in Ben-Zeev D, et al., 2014. Participants were asked to rate their agreement with a series of statements about the intervention (26-items) using three Likert Scale responses (disagree, neutral, or agree) for each item. The number of responses in each category of disagree, neutral, or agree were summed and averaged across the total number of participants who responded to report an overall percentage within each category of disagree, neutral, or agree on the acceptability and usability of the device. A higher overall percentage of 'agree' responses indicate a higher degree of usability as rated by participants.
Observed Adherence (Feasibility) to Walking Program Schedule Based on Percentage of Scheduled Sessions Completed
时间窗: 28 days
Percentage of scheduled sessions completed (5 times per week for 4 weeks)
Safety (Feasibility) Based on the Number of Adverse Events During Training
时间窗: 28 days
Safety as assessed by number of adverse events during training with the music-based device
Change in Mobility Impact Based on the Mobility Dimension of the Parkinson's Disease Questionnaire-39 (PDQ-39) Between Baseline to Last Visit
时间窗: 28 days
Mobility impact as assessed by Parkinson's Disease Questionnaire-39 (PDQ-39) mobility dimension (questions #1-10 from the total PDQ-39 questionnaire). Each question is scored on a 0-4 ordinal scoring system then summed to generate the sub-scale score of the mobility dimension. Lower scores represent better quality of life. Mobility Dimension Subscale Range: 0-100
次要结局
- Overall Quality of Life Impact Based on the Total Parkinson's Disease Questionnaire -39 (PDQ-39)(28 days)
- Change in Disease Severity Based on the Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III)(28 days)
- Change in Walking Endurance (m)(28 days)
- Change in Fast Walking Gait Speed (m/s)(28 days)
- Change in Intensity (Moderate Intensity Minutes; >100 Steps/Min)(8 days)
- Change in Mobility(28 days)
- Change in Amount of Walking (Steps/Day)(8 days)