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临床试验/NCT05616832
NCT05616832已完成不适用

Examining the Association Between Psychosocial Factors and Adherence to a Home Exercise Program for Upper Extremity Recovery in Veteran Stroke Survivors

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Home Exercise Program adherence

研究概览

简要总结

Research shows that exercising at home can improve arm and hand movement after a stroke. Unfortunately, it can be hard to exercise enough to make a difference in arm and hand movement after stroke. In this study, the investigators will try to determine things that make it easy or hard for Veterans to exercise their arm and hand after a stroke. In this study, the investigators will recruit Veteran stroke survivors who have difficulty using their arm and hand after a stroke. First, the investigators will administer surveys and questionnaires to get Veteran stroke survivors' perspectives on their self-confidence, mood, sleep, and more. Then, the investigators will ask them to track their home exercise using a wearable movement tracker (like a smart watch). Then, Veteran stroke survivors will meet with a researcher to talk about their experience doing home exercise and why they think it was easy or hard to do.

详细描述

Stroke affects nearly 800,000 people in the United States annually. Around 15,000 Veterans are admitted to Veterans Affairs (VA) facilities per year with stroke, and Veterans attend approximately 60,000 outpatient visits for stroke each year. Upper extremity (UE) impairment is a common consequence of stroke that requires ongoing outpatient visits for treatment. UE impairment reduces individuals' ability to perform activities for self-care, employment, and recreation, thereby diminishing independence and quality of life.

Extensive repetitions of UE activity improve functional recovery of the UE post-stroke. However, the high amount of UE activity necessary for neuroplasticity and functional recovery is not achieved within typical therapy sessions. To circumvent limited time with a therapist, a home exercise program (HEP) is commonly prescribed. Unfortunately, patient adherence to HEP is known to be low,16-19 resulting in poor motor recovery.

Behavioral interventions are effective in improving adherence to medication regimes for people with diabetes and hypertension, as well as for physical activity among older adults. Thus, there is a growing call to provide behavioral interventions within rehabilitation to increase adherence. However, there is no evidence for efficacy of such interventions in stroke rehabilitation, let alone specifically for Veterans. Only one systematic review exists to find that 4 out of 5 randomized controlled trials failed to show statistically significant differences for a behavioral intervention over control in increasing physical activity adherence for stroke survivors among the general population. This result indicates that conventional behavioral interventions are inadequate to address adherence to HEP post-stroke. This is likely because practicing HEP after stroke is more difficult than taking medication, and promoting adherence to HEP post-stroke requires more consideration of individual survivors' psychosocial factors than is needed for medication adherence. Therefore, understanding Veteran stroke survivors' psychosocial factors is the key to developing a behavioral intervention that adequately addresses barriers to increase adherence to HEP and promote recovery.

Study design: The study will be an observational pilot study using a single group of Veteran stroke survivors.

Home exercise program: Participants will be asked to complete a home exercise program consisting of upper extremity movement to meet a daily activity goal measured by a wrist-worn tracker (like a smartwatch).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • U.S. Veteran
  • History of stroke
  • Stroke-related hand impairment requiring concurrent standard rehabilitation therapy or for which participant indicates interest in obtaining rehabilitation therapy
  • Ability to engage in therapeutic tasks, demonstrated by grasping and moving a small, everyday object such as keys or phone with affected hand
  • Can put on a wrist-worn device like a watch on the paretic wrist every day, either using the nonparetic hand or with assistance from a caregiver
  • Can read and understand words and numbers on a smart phone screen

排除标准

  • No volitional movement of the affected UE
  • Language barrier or cognitive impairment that precludes following 3-step commands and/or providing consent

研究组 & 干预措施

Veterans with upper extremity impairment after stroke

Veterans with upper extremity impairment after stroke will be recruited for this study.

结局指标

主要结局

Home Exercise Program adherence

时间窗: 2 weeks

Home Exercise Program adherence will be quantified as the average percent of an upper extremity activity goal met daily over 7 days after a 3-day baseline period during which activity will be tracked but no home exercise program will be completed. Accommodating for the 3-day baseline period, the 7-day home exercise program period, and any scheduling issues, the total time frame to complete this outcome will be no more than 2 weeks.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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