NCT03778905

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!

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2018

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2019

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

11 days

First QC Date

December 10, 2018

Last Update Submit

July 26, 2020

Conditions

Outcome Measures

Primary Outcomes (10)

  • Activity of daily life function

    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)

    35 days

  • Nutritional status

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

    35 days

  • Oral intake function

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

    35 days

  • Cardiopulmonary capacity

    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.

    35 days

  • Walking speed

    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.

    35 days

  • Upper motor hand function

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

    35 days

  • Life quality

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

    35 days

  • Balance and coordination

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

    35 days

  • Cognition

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

    35 days

  • Speech function

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

    35 days

Study Arms (1)

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

Interventions

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

stroke patient with complete post-acute care hospitalization

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • \>18 y/o
  • acute onset of stroke within 30 days
  • Modified Rankin Scale 2\~4

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chi Mei Medical Center

Tainan, 71004, Taiwan

Location

MeSH Terms

Conditions

Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Willy Chou, MD, MS

    Chi Mei Medical Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of physical medicine and rehabiliation

Study Record Dates

First Submitted

December 10, 2018

First Posted

December 19, 2018

Study Start

December 3, 2018

Primary Completion

December 14, 2018

Study Completion

June 22, 2019

Last Updated

July 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data (IPD) available to other researchers.

Locations