Usability Study of "ArmAssist 2.0." Robot: Homecare Arm Rehabilitation in Acute, Subacute and Chronic Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Quebec User Evaluation of Satisfaction with assistive Technology: QUEST scale
研究概览
简要总结
The purpose of this study is to validate the usability of ArmAssist medical device, a robotic system for the rehabilitation of upper limbs in stroke patients (based on serious games). This study evaluate the usability of the system in a home environment, taking into account the ease-to-use, consistency and others; and will pretend demonstrate the feasibility of including or no, robotic therapy in home like complement of daily rehabilitation program. Finally this study investigate the acceptance from patients and therapists.
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
- •Subjects over 18,
- •Upper limb hemiparesis after stroke,
- •Unilateral paresis and cognitive ability to understand,
- •Accept and actively participate in the usability study.
排除标准
- •Bilateral motor deficit,
- •Severe spasticity,
- •Psychiatric illness,
- •and/or cognitive impairment.
结局指标
主要结局
Quebec User Evaluation of Satisfaction with assistive Technology: QUEST scale
时间窗: Through study completion, an average of 3 weeks
The purpose of this scale is to evaluate how satisfied the patient are with the assistive device and the related services they experienced. It consists of twelve questions, eight related to the device and four related to services of 12 satisfaction items with answers from 1 'Not satisfied at all' to 5 'Very satisfied'
System Usability Scale: SUS
时间窗: Through study completion, an average of 3 weeks
This scale provides a quick, reliable tool for measuring the usability. It consists of 10 item questionnaire and answers from 1 'strongly agree' to 5 'strongly disagree'. Scores are ranging to 0-100 %, where a high score means better usability with a higher score meaning better usability
Usability questionnaire specifically designed for the use of ArmAssist 2.0
时间窗: Through study completion, an average of 3 weeks
It consists of a 19 item questionnaire with seven response options (Likert sacle) for respondents; from Strongly agree to Strongly disagree. To evaluate the satisfaction of patients and therapist with the system and the therapy.
Intrinsic Motivation Inventory: IMI
时间窗: Through study completion, an average of 3 weeks
This scale is a multidimensional scale intended to assess participants subjective experience with the device (interest/enjoyment, perceived competence, effort, value/usefulness, felt pressure and tension, and perceived choice while performing a given activity). Consist of 20 item questionnaire with answers from 1 'strongly agree' to 7 'strongly disagree'.
Structured interviews: Willingness-to-pay questionnaire
时间窗: Through study completion, an average of 3 weeks
This interview consists in two short questions to ask to participants about the willingness-to-pay for ArmAssist 2.0. system as therapy.
次要结局
- Modified Asworth Scale (MAS)(Baseline, 3 weeks)
- Fugl-Meyer Assessment (FMA) scale(Baseline, 3 weeks)