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临床试验/NCT05393661
NCT05393661进行中(未招募)不适用

Implementation of Focused Intensive Repeated Stepping Training (FIRST) During Inpatient Rehabilitation Poststroke - A Quality Improvement Project

Indiana University2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
2,000
试验地点
2
主要终点
Change in 10 meter walk test

研究概览

简要总结

The purpose of this quality improvement project was first to monitor usual physical therapy care (types & cardiovascular intensity of interventions and amount of stepping practice provided) and outcomes. Following which educational training and support was provided to treating physical therapists to encourage implementation of evidence-based practices. Specifically, therapists were encouraged to prioritize the practice of walking, particularly at higher cardiovascular intensities during scheduled therapy sessions. Fidelity metrics in the form of chart audits and pedometer-based step counts were utilized to determine compliance with the evidence-based intervention and ultimately investigated for potential effects on patient outcome measures.

详细描述

Converging data over the past 20 years suggest that the provision of large amounts of walking practice can improve walking function for individuals poststroke with greater improvements observed when the walking training is performed at moderate to high aerobic intensities. Despite this, current physical therapy practice during inpatient rehabilitation suggests limited walking practice is provided and low cardiovascular intensities achieved.

The purpose of this current quality improvement project is to evaluate the feasibility of implementing Focused, Intensive, Repeated Stepping Training (FIRST) during routine inpatient physical therapy and potential effects on patient outcome measures.

Prior to the usual care phase of the project, the outcome measures team worked to standardize routine collection of specific outcome measures (10 meter walk test, 6 minute walk test, Berg Balance Scale) at regular intervals (admission, weekly, discharge) in addition to 3rd party payer mandated measures (e.g., Functional Independence Measure; FIM). After which, existing physical therapy practice and outcomes will be monitored for a period of approximately 9-12 months. After which, educational training will be provided to physical therapists associated with the management of these patients as well as ongoing support (e.g., didactic, psychomotor, technical) and audit/feedback (e.g., chart audits, step count feedback) with fidelity metrics monitored from chart audits (walking practiced, walking prioritized, cardiovascular intensity documented, target intensity achieved) and pedometer step counts.

Potential changes in locomotor (e.g., 10 meter walk test, 6 minute walk test), non-locomotor outcomes (Berg Balance Scale, FIM-bed to chair transfers, FIM - toilet transfers), and incidence of adverse events will be evaluated if fidelity metrics indicate meaningful changes in clinical practice patterns. It is currently unknown what values of the fidelity metrics indicate successful implementation of the FIRST intervention, what knowledge translation strategies may be most effective to yield changes in therapists practice patterns, or the duration of time necessary to sufficiently achieve these changes in practice.

研究设计

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

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • < 2 months poststroke

排除标准

  • restrictions in lower extremity weightbearing (e.g., amputation or lower limb fracture)
  • unable to ambulate > 50 m prior to their most recent stroke
  • discharged to home from inpatient rehabilitation after < 1 week

结局指标

主要结局

Change in 10 meter walk test

时间窗: Time from admission & discharge inpatient rehabilitation or approximately 20 days

Differences in time for individual to ambulate 10 meters (with middle 6 meters timed) with directions "walk at your usual, comfortable pace" from admission and discharge from inpatient rehabilitation

Change in 6 minute walk test

时间窗: Time from admission & discharge inpatient rehabilitation or approximately 20 days

Differences in distance able to be ambulated during a 6 minute period with directions "cover as much ground as possible" from admission and discharge from inpatient rehabilitation

Change in 6 minute walk test level of assistance

时间窗: Time from admission & discharge inpatient rehabilitation or approximately 20 days

Differences in amount of physical assistance provided by physical therapist during 6 minute walk test

Change in 10 meter walk test

时间窗: Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.

Differences in time for individual to ambulate 10 meters (with middle 6 meters timed) with directions "walk at your usual, comfortable pace" from admission and discharge from inpatient rehabilitation

Change in 6 minute walk test

时间窗: Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.

Differences in distance able to be ambulated during a 6 minute period with directions "cover as much ground as possible" from admission and discharge from inpatient rehabilitation

Change in 6 minute walk test level of assistance

时间窗: Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.

Differences in amount of physical assistance provided by physical therapist during 6 minute walk test

次要结局

  • Change in Functional Independence Measure - stairs(Time from admission & discharge inpatient rehabilitation or approximately 20 days)
  • Change in Berg Balance Scale(Time from admission & discharge inpatient rehabilitation or approximately 20 days)
  • Change in Functional Independence Measure - bed to chair transfer subscore(Time from admission & discharge inpatient rehabilitation or approximately 20 days)
  • Change in Functional Independence Measure - toilet transfer subscore(Time from admission & discharge inpatient rehabilitation or approximately 20 days)
  • Change in Functional Independence Measure - locomotion(Time from admission & discharge inpatient rehabilitation or approximately 20 days)
  • Change in Berg Balance Scale(Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.)
  • Change in Functional Independence Measure - bed to chair transfer subscore(Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.)
  • Change in Functional Independence Measure - toilet transfer subscore(Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.)
  • Change in Functional Independence Measure - locomotion(Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.)
  • Change in Functional Independence Measure - stairs(Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.)

研究者

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

George Hornby

Professor of Physical Medicine and Rehab

Indiana University

研究点 (2)

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