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临床试验/NCT04245449
NCT04245449终止不适用

A Novel Therapy + E-learning Self-management Program for Stroke Survivors

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2019年8月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
7
试验地点
1
主要终点
Change in Health Literacy From Baseline to 3 Months

研究概览

简要总结

Stroke survivors with arm paresis because of stroke use their "good" arm for daily activities, but in doing so may be self-limiting their own recovery of the "bad" arm. Traditional models of stroke rehabilitation fail to fully engage the survivor and care partner(s) in actively planning post-discharge habits that improve their capacity to live well over their entire lives. This study will test a cutting-edge in-person therapy + online training program designed to progressively transfer the responsibility of driving post-stroke recovery from the therapist to the survivor.

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
21 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •paresis of one arm/hand because of ischemic or hemorrhagic stroke >2 mo. and <3 yrs prior
  • •moderate arm impairment defined as a baseline Fugl-Meyer Assessment of the Upper Extremity score of at least 32±2 points but no more than 47±2 points (out of 60 points)
  • •Montreal Cognitive Assessment score ≥22
  • •ability to read English
  • •ability to communicate as per the therapists' judgement at baseline testing
  • •21-90 years of age
  • •wi-fi connection in the home and either a computer, smartphone or tablet.

排除标准

  • •lesion or injury to brainstem or cerebellum
  • •other neurological disease that may impair motor or learning skills (e.g., Parkinson's Disease);
  • •pain interfering with reaching
  • •uncorrected vision making it difficult to read information on a computer, tablet or phone.

研究组 & 干预措施

e learning+therapy (TEAACH)

Experimental

TEAACH-Training to Empower Activity-dependent plasticity-based Arm-use habits in the Community and at Home

干预措施: TEAACH (Behavioral)

结局指标

主要结局

Change in Health Literacy From Baseline to 3 Months

时间窗: Baseline Visit and 3 months

Health Literacy will be assessed via a standardize 18-item test designed to assess an adult's ability to read and understand common medical terms. Minimum = 0, Maximum = 18. Higher scores indicate greater health literacy.

Change in Self Management Skills From Baseline to 3 Months

时间窗: Baseline and 3 months

Participants' ability to manage their chronic condition (their stroke) will be assessed qualitatively using interview questions. Participants' narratives will be analyzed and reported as a description of how their own skills have changed.

次要结局

  • Change in Self-Efficacy for Managing Daily Activities From Baseline to 3 Months and 5 Months(Baseline Visit, 3 months and 5 months)
  • Change in Social Isolation From Baseline to 3 Months and 5 Months(Baseline Visit, 3 months & 5 months)
  • Change in Emotional Support From Baseline to 3 Months and 5 Months(Baseline Visit, 3 months (Post Treatment+/- 3 days), & 5 months (Follow up +/- 3 days))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michelle Woodbury

Associate Professor

Medical University of South Carolina

研究点 (1)

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