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临床试验/NCT07557940
NCT07557940已完成不适用

Real World Upper Extremity Activity of Stroke Survivors

Shirley Ryan AbilityLab0 个研究点目标入组 15 人开始时间: 2014年11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
15
主要终点
Action research arm test

研究概览

简要总结

The investigators want to objectively measure, through the use of accelerometers, the time, movement intensity, and bilaterality of Upper Extremity (UE) activity and see if these improve over the course of therapy.

详细描述

Occupational therapists utilize a battery of standardized assessments at evaluation and throughout the duration of services. These performance-based assessments measure abilities at impairment and activity levels (e.g. grip strength and the Action Research Arm Test). The assumption is made that improved performance on these in-clinic assessments correlates to increased UE activity outside the clinic in daily life. This assumption however, is unsupported by current evidence. Currently, self report measures (e.g. Stroke Impact Scale, Motor Activity Log) are used in both clinical and research settings to gather data on activity outside of therapy time. These measures however, are subject to bias, particularly for physical activity. Social desirability, or the tendency of individuals to portray themselves in keeping up with norms, has been linked specifically to the bias of self report measures. It was found that durations of light and moderate activity were over reported by as much as 79 min/day. These numbers indicate that participants tend to overestimate the amount of activity throughout their day in order to please their provider according to their perceived acceptable norms.

In recent years, accelerometry has been established as an objective, unbiased tool for measuring real world UE activity. Accelerometers have been used to track UE activity in the inpatient rehabilitation setting and then compared to healthy controls. This comparison indicated that healthy individuals use their dominant and non-dominant arms 8-9 hours per day. Individuals with stroke demonstrate significantly less UE use; using their affected arm approximately 3.3 hours and their unaffected arm 6.0 hours per day. A recent study with community dwelling healthy individuals confirmed that healthy individuals use their dominant hand 9 hours and their non-dominant hand 8.6 hours per day. These newer data indicate that regardless of dominance, patients post stroke use their affected limb significantly less than healthy individuals in the community.

Using the framework from previous accelerometry studies, the proposed research study will address the critical need to understand real world UE activity in stroke survivors undergoing standard outpatient occupational therapy. The investigators want to objectively measure, through the use of accelerometers, the time, movement intensity, and bilaterality of UE activity and see if these improve over the course of therapy. These data will help clinicians understand actual UE usage during everyday activities outside of prescribed therapy time. Clinicians will be able to tell if the interventions they are providing are increasing activity in the real world, and not just increasing patient performance in the clinic.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Diagnosis of unilateral stroke, according to ICD-9 criteria, resulting in residual upper extremity hemiparesis
  • At least 18 years of age
  • Receiving occupational therapy in outpatient or day rehabilitation setting
  • Motricity Index Score between 29-91 points
  • Ability to follow a 1 step command as indicated by a score of 0 to 1 on the command items of the National Institute of Health Stroke Scale (NIHSS)
  • All subject must have the ability to provide signed, informed consent

排除标准

  • • A history of other diagnosed neurological condition
  • A history of other diagnosed psychiatric condition
  • Inability to follow 1 step command
  • Currently pregnant or seeking pregnancy

结局指标

主要结局

Action research arm test

时间窗: change from baseline to post 30 days, and discharge from inpatient hospitalization up to 12 weeks)

the ARAT, two sections of the Stroke Impact Scale will be administered via interview format. The two sections (hand and participation in activities at home) will capture each subject's perceived participation related to UE activity.

次要结局

  • Stroke Impact Scale (SIS)(change from baseline at time of enrollment to post 30 days, and discharge from inpatient hospitalization (up to 12 weeks))
  • Accelerometry metrics(change from baseline at time of enrollment to post 30 days, and discharge from inpatient hospitalization (up to 12 weeks))

研究者

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

Thomas G Hornby

PT, PhD

Shirley Ryan AbilityLab

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