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Completed

NCT Number: NCT03778905

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

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!

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Chi Mei Medical Center

Tainan, 71004, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rehabilitation

Other

The stroke patients who admitted to post acute care(PAC) institution would undergo regular rehabilitation.

Primary outcomes

  1. 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)

  2. Nutritional status

    Time frame: 35 days

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

  3. 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.

  4. Cardiopulmonary capacity

    Time frame: 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.

  5. Walking speed

    Time frame: 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.

  6. Upper motor hand function

    Time frame: 35 days

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

  7. Life quality

    Time frame: 35 days

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

  8. Balance and coordination

    Time frame: 35 days

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

  9. Cognition

    Time frame: 35 days

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

  10. Speech function

    Time frame: 35 days

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

Sponsors and collaborators

Lead sponsor

Chimei Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Dec 19, 2018
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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