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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03778905
• Other study ID #: CMMC10711-J02
• Status: Completed
• Start date: December 3, 2018
• Est. completion date: June 22, 2019

Study information

• Verified date: July 2020
• Source: Chimei Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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!

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: June 22, 2019
• Est. primary completion date: December 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Taiwan	Chi Mei Medical Center	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
Chimei Medical Center

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Nutritional status	Nutritional status is evaluated by Mini nutritional assessment(Range: 0.0~30.0). Higher score indicates better function	35 days
Primary	Oral intake function	Oral intake is evaluated by Functional oral intake scale(Range: level 1~7). Higher level indicates better function.	35 days
Primary	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
Primary	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
Primary	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
Primary	Life quality	Life quality is evaluated by EuroQoL-5D(Range: 5~15 scores). Lower scores indicate better life quality.	35 days
Primary	Balance and coordination	Balance and coordination is evaluated by Berg-Balance test(Range: 0~56). Higher scores indicate better function.	35 days
Primary	Cognition	Cognition is evaluated by Mini-Mental Sate Examination(Range: 0~30 score). Higher scores indicate better cognition.	35 days
Primary	Speech function	Speech function is evaluated by Concise Chinese Aphasia Test(Range: 1~12 scores). Higher scores indicate better speech function	35 days