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

Sponsor
Chimei Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03778905
Collaborator
(none)
305
1
6.6
46.2

Study Details

Study Description

Brief Summary

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!

Condition or Disease Intervention/Treatment Phase
  • Other: Rehabilitation

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 Design

Study Type:
Observational
Actual Enrollment :
305 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
The Correlation Between the Length of Stay in Post Acute Care(PAC) and General Improvements in Stroke Patients
Actual Study Start Date :
Dec 3, 2018
Actual Primary Completion Date :
Dec 14, 2018
Actual Study Completion Date :
Jun 22, 2019

Arms and Interventions

Arm 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.

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

Outcome Measures

Primary Outcome Measures

  1. Activity of daily life function [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 [35 days]

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

  3. Oral intake function [35 days]

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

  4. Cardiopulmonary capacity [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 [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 [35 days]

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

  7. Life quality [35 days]

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

  8. Balance and coordination [35 days]

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

  9. Cognition [35 days]

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

  10. Speech function [35 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chi Mei Medical Center Tainan Taiwan 71004

Sponsors and Collaborators

  • Chimei Medical Center

Investigators

  • Study Director: Willy Chou, MD, MS, Chi Mei Medical Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Willy Chou, Director of physical medicine and rehabiliation, Chi Mei Medical Hospital
ClinicalTrials.gov Identifier:
NCT03778905
Other Study ID Numbers:
  • CMMC10711-J02
First Posted:
Dec 19, 2018
Last Update Posted:
Jul 28, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2020