Promoting Adherence in Upper Extremity Home-based Rehabilitation Through Motivational Interviewing and Ecological Momentary Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Rates of adherence at individual and group level measured through frequency
研究概览
简要总结
The objective of the proposal is to determine the feasibility of implementing Ecological Momentary Assessment (EMA) and Motivational Interviewing (MI) methods to enhance adherence for a 4-week self-initiated arm training protocol. A non-randomized feasibility study using a 4-week UE training protocol will be conducted in 15 individuals within the first 12 months post-stroke living in the community. EMA data will be collected using a mobile app to automate real-time collection of adherence data on a daily basis. MI will be used to produce self-generated training plans (training goals, training schedule), guided by the therapist before the start of training.
详细描述
Using a mixed methods design, the study will collect quantitative data before, during, and after training. Qualitative data will be collected after the training period and analyzed to explain the quantitative findings in depth, within the context of everyday life. Study aim 1 is to evaluate the feasibility of using EMA to measure adherence and of applying the MI approach. Quantitative data will include four indicators of adherence and accuracy. Interview responses will be used as qualitative data to elucidate participants' acceptance of the MI approach and feedback on using the EMA app. Study aim 2 is to explore to what extent UE outcomes change after the 4-week self-initiated home-based rehabilitation program. Outcomes will include UE use in real-world environments and self-perceived changes in UE use.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (> 18 years old) diagnosed with stroke at least 6 months ago at the time of screening
- •Living in the community
- •Have presence of UE motor impairment on the affected side (Fugl-Meyer Assessment scores < 66)
- •Availability of mobile technology (tablet or smartphone) with internet connection to use phone app and Zoom videochat)
- •Be medically stable
- •Able to provide written consent
排除标准
- •Currently receiving active occupational or physical therapy for the treatment of the affected UE
- •Presence of severe cognitive impairment (Mini Mental Status Exam <24)
- •Self-reported moderate to severe pain of the affected UE with use
- •Presence of unilateral spatial neglect (Star Cancellation Task scores < 44)
- •Presence of neurological diagnosis other than stroke.
结局指标
主要结局
Rates of adherence at individual and group level measured through frequency
时间窗: Day 39 visit
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Rates of adherence at individual and group level measured through intensity
时间窗: Day 39 visit
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Rates of adherence at individual and group level measured through duration
时间窗: Day 39 visit
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Decision making factors effecting the program adherence through semi-structured interviews
时间窗: Day 39 visit
Semi-structured interviews will be conducted with all participants to collect qualitative data on participants' experiences related to the shared decision-making process in phase 1, and adherence to arm training in phase 2 of study.
次要结局
- Change scores in Motor Activity Log from baseline to discharge and baseline to follow-up(Day 4 visit, Day 37-39 visit, Day 65-67 visit)
- Change scores in Fugl-Meyer Assessment from baseline to discharge and baseline to follow-up(Day 4 visit, Day 37-39 visit, Day 65-67 visit)
- Change scores in UE accelerometry data calculated using bilateral magnitude ratio from baseline to discharge and baseline to follow-up.(Day 4 visit, Day 37-39 visit, Day 65-67 visit)
- Change scores in Canadian Occupational Performance Measure from baseline to discharge and baseline to follow-up(Day 4 visit, Day 37-39 visit, Day 65-67 visit)