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临床试验/NCT03778905
NCT03778905已完成不适用

The Correlation Between the Length of Stay in Post Acute Care(PAC) and General Improvements in Stroke Patients

Chimei Medical Center1 个研究点 分布在 1 个国家目标入组 305 人开始时间: 2018年12月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
305
试验地点
1
主要终点
Cardiopulmonary capacity

研究概览

简要总结

Post-Acute Care(PAC) had been inaugurated in Taiwan for almost four years and current essays revealed positive effects upon general improvements in stroke patient after PAC training. During acute phase, a stroke patient would admit to internal medicine or surgical ward and transferred to rehabilitative ward for more intensive therapeutic programs, restoring muscle power and promoting activity of daily life(ADL) ability. Under relative stable condition, the patient would transfer to PAC institution or hospitals afterwards for continuing rehabilitative program if the patient is acknowledged to have rehabilitative potentials. However, there's still lacking of investigation upon whether the length of stay in PAC correlates to general improvements. Thus, stroke patients' functional ability, such as activities of daily living (ADL) function, swallowing ability and so on, as well as their corresponding scales were assessed on the first and last day during PAC hospitalization. Statistical analysis was conducted via SPSS ver21.0 to compare the relationship of improvements in functional ability and the length of stay in PAC. We're looking forward to the final results!

详细描述

Functional ability in stroke patients are evaluated by following measurements. Activity of daily life (ADL) function was estimated through modified Rankin scale(MRS) and Barthel index(BI), swallowing ability by functional oral intake scale, nutritional status via mini nutritional assessment, life quality through EuroQoL-5D, instrumental ADL function by Lawton-Brody IADL Scale(IADL), balance/coordination via Berg Balance Test, walking speed through Usual Gait Speed, cardiopulmonary capability by Six-Minute Walk Test, occupational mobility (amount use/quality) via Motor Activity Log, language through concise Chinese aphasia test, motor function of upper extremities by Fugl-Meyer Assessment and so on.

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •acute onset of stroke within 30 days
  • •Modified Rankin Scale 2~4

排除标准

  • •patients refused to join post acute care(PAC) program
  • •hemodynamic unstable
  • •disease progression

结局指标

主要结局

Cardiopulmonary capacity

时间窗: 35 days

Cardiopulmonary capacity is evaluated by 6-minute walk test, which requires the patients to walk as much as they can within 6 minutes. Walking length is presented in meters. Longer distance and more meters indicate better function.

Activity of daily life function

时间窗: 35 days

Activity of daily life function is evaluated by both Barthel index(Range: 0\~100 score; higher score indicates better function) and Modified Rankin Scale(Grade 1\~6; the lower grade indicates better function). Task-oriented activity of daily life is assessed by Industrial activity of daily life(Range: Male 0\~5 score and female 0\~8 score; Higher score indicates better function)

Cognition

时间窗: 35 days

Cognition is evaluated by Mini-Mental Sate Examination(Range: 0\~30 score). Higher scores indicate better cognition.

Speech function

时间窗: 35 days

Speech function is evaluated by Concise Chinese Aphasia Test(Range: 1\~12 scores). Higher scores indicate better speech function

Nutritional status

时间窗: 35 days

Nutritional status is evaluated by Mini nutritional assessment(Range: 0.0\~30.0). Higher score indicates better function

Oral intake function

时间窗: 35 days

Oral intake is evaluated by Functional oral intake scale(Range: level 1\~7). Higher level indicates better function.

Walking speed

时间窗: 35 days

Walking speed is evaluated by Usual Gait Speed, which require the patients to walk certain distance and record the time that needed to finish the whole course. Time is presented with seconds. The shorter time and lower seconds indicate better function.

Upper motor hand function

时间窗: 35 days

Upper motor hand function is evaluated by Fugl-Meyer assessment(Range 0\~44 scores) Higher scores indicate better function.

Balance and coordination

时间窗: 35 days

Balance and coordination is evaluated by Berg-Balance test(Range: 0\~56). Higher scores indicate better function.

Life quality

时间窗: 35 days

Life quality is evaluated by EuroQoL-5D(Range: 5\~15 scores). Lower scores indicate better life quality.

次要结局

未报告次要终点

研究者

发起方
Chimei Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Willy Chou

Director of physical medicine and rehabiliation

Chi Mei Medical Hospital

研究点 (1)

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