- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03778905
The Correlation Between the Length of Stay in Post Acute Care(PAC) and General Improvements in Stroke Patients
July 26, 2020 updated by: Willy Chou, Chimei Medical Center
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!
Study Overview
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
305
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tainan, Taiwan, 71004
- Chi Mei Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Stroke patient who meet up criteria of >18 y/o, acute onset of stroke within 30 days and Modified Rankin Scale 2~4 as well as complete post acute care(PAC) rehabilitative program.
Description
Inclusion Criteria:
- >18 y/o
- acute onset of stroke within 30 days
- Modified Rankin Scale 2~4
Exclusion Criteria:
- patients refused to join post acute care(PAC) program
- hemodynamic unstable
- disease progression
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
stroke patient with complete post-acute care hospitalization
This study aims on stroke patients with complete rehabilitative program in post acute care institution and we try to assess their functional improvements after rehabilitative training.
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The stroke patients who admitted to post acute care(PAC) institution would undergo regular rehabilitation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activity of daily life function
Time Frame: 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)
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35 days
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Nutritional status
Time Frame: 35 days
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Nutritional status is evaluated by Mini nutritional assessment(Range: 0.0~30.0).
Higher score indicates better function
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35 days
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Oral intake function
Time Frame: 35 days
|
Oral intake is evaluated by Functional oral intake scale(Range: level 1~7).
Higher level indicates better function.
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35 days
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Cardiopulmonary capacity
Time Frame: 35 days
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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.
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35 days
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Walking speed
Time Frame: 35 days
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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.
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35 days
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Upper motor hand function
Time Frame: 35 days
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Upper motor hand function is evaluated by Fugl-Meyer assessment(Range 0~44 scores) Higher scores indicate better function.
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35 days
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Life quality
Time Frame: 35 days
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Life quality is evaluated by EuroQoL-5D(Range: 5~15 scores).
Lower scores indicate better life quality.
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35 days
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Balance and coordination
Time Frame: 35 days
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Balance and coordination is evaluated by Berg-Balance test(Range: 0~56).
Higher scores indicate better function.
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35 days
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Cognition
Time Frame: 35 days
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Cognition is evaluated by Mini-Mental Sate Examination(Range: 0~30 score).
Higher scores indicate better cognition.
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35 days
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Speech function
Time Frame: 35 days
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Speech function is evaluated by Concise Chinese Aphasia Test(Range: 1~12 scores).
Higher scores indicate better speech function
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35 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Willy Chou, MD, MS, Chi Mei Medical Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 3, 2018
Primary Completion (Actual)
December 14, 2018
Study Completion (Actual)
June 22, 2019
Study Registration Dates
First Submitted
December 10, 2018
First Submitted That Met QC Criteria
December 17, 2018
First Posted (Actual)
December 19, 2018
Study Record Updates
Last Update Posted (Actual)
July 28, 2020
Last Update Submitted That Met QC Criteria
July 26, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMMC10711-J02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
There is no plan to make individual participant data (IPD) available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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