StrokeNCT03778905
The Correlation Between the Length of Stay in Post Acute Care(PAC) and General Improvements in Stroke Patients
An observational study of Stroke, run by Chimei Medical Center at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Rehabilitation
- How many people
- 305 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Dec 2018to 22 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- >18 y/o
- acute onset of stroke within 30 days
- Modified Rankin Scale 2~4
Who cannot join
- patients refused to join post acute care(PAC) program
- hemodynamic unstable
- disease progression
Trial locations and contacts
1 site in 1 country.
About this study
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!
Read the 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.
- Conditions
- Stroke
- Being tested
- Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
The stroke patients who admitted to post acute care(PAC) institution would undergo regular rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 35 days
Nutritional status
Nutritional status is evaluated by Mini nutritional assessment(Range: 0.0~30.0). Higher score indicates better function
Measured: 35 days
Oral intake function
Oral intake is evaluated by Functional oral intake scale(Range: level 1~7). Higher level indicates better function.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 35 days
Life quality
Life quality is evaluated by EuroQoL-5D(Range: 5~15 scores). Lower scores indicate better life quality.
Measured: 35 days
Balance and coordination
Balance and coordination is evaluated by Berg-Balance test(Range: 0~56). Higher scores indicate better function.
Measured: 35 days
Cognition
Cognition is evaluated by Mini-Mental Sate Examination(Range: 0~30 score). Higher scores indicate better cognition.
Measured: 35 days
Speech function
Speech function is evaluated by Concise Chinese Aphasia Test(Range: 1~12 scores). Higher scores indicate better speech function
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start3 Dec 2018
- Primary completion14 Dec 2018
- Study completion22 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chimei Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Willy Chou, Chi Mei Medical Hospital
- Investigators
- Willy Chou, MD, MS, Study director, Chi Mei Medical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778905
- Sponsor's protocol ID
- CMMC10711-J02
- Status last verified
- Jul 2020
- First submitted
- 10 Dec 2018
- Last updated
- 28 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between the Length of Stay in Post Acute Care(PAC) and General Improvements in Stroke Patients
- ClinicalTrials.gov ID
- NCT03778905
- Acronym / sponsor ID
- CMMC10711-J02
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Chimei Medical CenterUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 22 Jun 2019 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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!
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
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke patient with complete post-acute care hospitalization | – | Other: RehabilitationThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- >18 y/o
- acute onset of stroke within 30 days
- Modified Rankin Scale 2~4
Key exclusion criteria (3 listed)
- patients refused to join post acute care(PAC) program
- hemodynamic unstable
- disease progression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationThe stroke patients who admitted to post acute care(PAC) institution would undergo regular rehabilitation. | Other | stroke patient with complete post-acute care hospitalization |
Primary outcome
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)
Nutritional status
Time frame: 35 days
Nutritional status is evaluated by Mini nutritional assessment(Range: 0.0~30.0). Higher score indicates better function
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.
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.
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.
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.
Life quality
Time frame: 35 days
Life quality is evaluated by EuroQoL-5D(Range: 5~15 scores). Lower scores indicate better life quality.
Balance and coordination
Time frame: 35 days
Balance and coordination is evaluated by Berg-Balance test(Range: 0~56). Higher scores indicate better function.
Cognition
Time frame: 35 days
Cognition is evaluated by Mini-Mental Sate Examination(Range: 0~30 score). Higher scores indicate better cognition.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Willy Chou, MD, MS study director
Chi Mei Medical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Chimei Medical Center at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity of daily life function (time frame: 35 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.