Addressing Arm Non-use by Encouraging Idle-time Activity During Early Recovery From Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Ratio of Average Activity Duration (RAAD)
研究概览
简要总结
This project evaluates the feasibility of using custom wearable technology and associated procedures to increase activity of the more-involved upper extremity during the earliest stages of recovery from stroke by increasing the amount of therapeutic exercise during idle-time. The proposed research is relevant to public health because it takes steps to mitigate a significant problem in physical rehabilitation using low-cost technology to motivate and monitor idle-time exercise without adding significantly to clinician workloads. The project aligns with the NICHD / NCMRR Research Plan on Rehabilitation by exploiting a mobile health (mHealth) and sensor-based approach to promote health and wellness through participant-engaged, data-driven, individualized care.
详细描述
The experiments in this proposal will assess the functional utility and subjective patient experience using a personal exercise cueing system designed to reduce learned non-use of the hemiparetic arm in the days, and weeks immediately following stroke. Up to 36 stroke survivors will be asked to participate in 12 practice sessions each lasting approximately 90 minutes. Participants will be asked to perform simple exercises after receiving a vibration cue. In the first four sessions participants will tap the more-involved wrist; in the second four sessions they will passively move the more-involved elbow through a range of motion; in the final four sessions they will actively move the more-involved elbow through a range of motion.
Accelerometers in the wearable devices will monitor motion of the wrist during the exercise sessions. To verify functional utility of the system, the investigators will examine for differences in the duration of arm movement activity in the cued exercise sessions relative to uncued periods. After all the sessions are complete, subjective user experience will be assessed by asking participants to complete a series of surveys wherein they can provide information about their subjective experiences with the wearable device technology. To assess feasibility of long-term follow-up, the investigators will interview the participants two months later regarding how well they use the more-involved arm to perform daily activities. At this time, they will also be asked to wear the devices for two days to assess the ability to measure arm movement activity at follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •(General): The goal of this feasibility clinical trial is to assess the functional utility and subjective patient experience using a personal exercise cueing system designed to reduce learned non-use of the hemiparetic arm in the days, and weeks immediately following stroke. We therefore restrict inclusion to stroke survivors in the inpatient rehabilitation unit of Froedtert Memorial Hospital (Milwaukee, WI). Thus, candidate subjects will undergo screening by Dr. McGuire and his team prior to inclusion in the study. Stroke survivors shall have:
- •had a unilateral stroke within the last 30 days;
- •ability to give informed consent and be able to follow two-stage instructions;
- •a broad range of motor impairment as assessed using the upper extremity portion of the Fugl-Meyer Motor Assessment (i.e., UE-FM score <= 50 out of a possible 66);
- •age ≥ 18 yr. of age.
排除标准
- •(General) include:
- •Inability of subjects to give informed consent or follow two-stage instructions;
- •concurrent illness or severe pain limiting the capacity to conform to study requirements.
研究组 & 干预措施
Survivors of stroke in early stages of recovery
干预措施: Feasibility of idle time exercise (Behavioral)
结局指标
主要结局
Ratio of Average Activity Duration (RAAD)
时间窗: During device use in an inpatient setting (about 1 to 3 weeks of use).
The RAAD assesses the amount of measured arm activity during cued exercise epochs compared to non-cued epochs. A RAAD value greater than 1.0 indicates that the amount of arm activity in response to Souvenir cues exceeded the amount of activity during non-cued periods of time.
System Usability Scale
时间窗: Two time points: After device use in an inpatient setting (after about 1 to 3 weeks of use); after device use in home settings (after 2 days of use).
The System Usability Scale (SUS) assesses the usability of the activity cueing system and monitoring system within the context of encouraging therapeutic arm activity. Scores are provided on a scale ranging from 1 to 100, with higher scores indicating greater perceived usability. Scores greater than 68 are generally considered to indicate "passable" usability.
Intrinsic Motivation Inventory (IMI)
时间窗: After device use in an inpatient setting (after about 1 to 3 weeks of use).
The IMI assesses subjective experience of motivation in response to the system's vibrotactile cues. IMI comprises 37 questions, with answers provided on a Likert scale (1-7). IMI questions span 6 psychosocial dimensions: * interest/enjoyment; higher scores = more interest/enjoyment with cued activities * effort/importance; higher scores = more perceived importance and more effort put into performing cued activities * value/usefulness higher scores = more perceived value and usefulness of cued activities * perceived choice; higher scores = greater degree to which participants felt that they had choice in engaging with the cued activities * perceived competence; higher scores = greater degree of competence performing cued activities * pressure/tension; higher scores = more anxiety/tension performing cued activities. A composite score is computed within each dimension by averaging item responses after reversing specified negative items; a score of 4 separates (+) from (-) experiences.
Quebec User Evaluation of Satisfaction With Technology (QUEST)
时间窗: Two time points: After device use in an inpatient setting (after about 1 to 3 weeks of use); after device use in home settings (after 2 days of use).
The QUEST assesses user satisfaction with the system and its delivery by the research team.. The QUEST comprises 12 questions, with answers provided on a Likert scale (1-5). For each question, a score of "1" = not at all satisfied where "5" is "very satisfied". A composite score (min = 1; max = 5) is computed for the QUEST by averaging across all questions. A score of 3 separates (+) from (-) experiences.
次要结局
未报告次要终点