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Functional Recovery Effects on Comprehensive Rehabilitation for Post-acute Care -Cerebrovascular Diseases

Primary Purpose

Cerebrovascular Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Comprehensive Rehabilitation
Sponsored by
Taipei City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cerebrovascular Diseases focused on measuring Post Acute Care(PAC), Cerebrovascular diseases

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • stroke patients who suffer from stroke within one month and have potential of rehabilitation
  • PT, OT or ST will be done for two hour each every day and 5 days per week for 6-12 weeks.

Exclusion Criteria:

  • Onset over 6 months

Sites / Locations

  • Taipei City Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Comorbidity_Comprehensive Rehabilitation

MRS_Comprehensive Rehabilitation

MMSE_Comprehensive Rehabilitation

BSRS_Comprehensive Rehabilitation

Arm Description

Charlson Comorbidity Index contains 19 categories of comorbidity and predicts the ten-year mortality for a patient who may have a range of co-morbid conditions Each condition is assigned with a score of 1,2,3 or 6 depending on the risk of dying associated with this condition. For a physician, it is helpful in knowing how aggressively to treat a condition. Higher scores indicating greater comorbidity (patients with a score > 5 have essentially a 100% risk of dying at one year).

The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death.

The mini mental state examination (MMSE) is the most commonly used instrument for screening cognitive function. This examination is not suitable for making a diagnosis but can be used to indicate the presence of cognitive impairment, such as in a person with suspected dementia or following a head injury. The examination has been validated in a number of populations. Scores of 25-30 out of 30 are considered normal; the National Institute for Health and Care Excellence (NICE) classifies 21-24 as mild, 10-20 as moderate and <10 as severe impairment. The MMSE may not be an appropriate assessment if the patient has learning, linguistic/communication or other disabilities (eg, sensory impairments).

Brief Symptom Rating Scale is a rating scale which a clinician or researcher may use to measure psychiatric symptoms such as depression, anxiety, hallucinations and unusual behavior. Each symptom is rated 1-7 and depending on the version between a total of 18-24 symptoms are scored. The scale is the one of the oldest, widely used scales to measure psychotic symptoms and was first published in 1962.

Outcomes

Primary Outcome Measures

Barthel Index improvement

Secondary Outcome Measures

Full Information

First Posted
December 1, 2014
Last Updated
December 5, 2014
Sponsor
Taipei City Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02311036
Brief Title
Functional Recovery Effects on Comprehensive Rehabilitation for Post-acute Care -Cerebrovascular Diseases
Official Title
Effect and Outcome Predictors on Functional Recovery After Comprehensive Rehabilitation for Post-acute Care -Cerebrovascular Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei City Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to investigate the effects and outcome predictors on functional recovery after comprehensive rehabilitation for post-acute care -cerebrovascular diseases.
Detailed Description
The investigators will collect 165 acute stroke patients who suffer from stroke within one month and have potential of rehabilitation. The participants will be divided into mild, moderate and severe groups according to Modified Rankin Scale (MRS). The patients are admitted for 6 weeks or extend to 12 weeks if necessary after evaluation. Comprehensive rehabilitation programs including Physical Therapy (PT), Occupational Therapy (OT) or Speech Therapy (ST) will be done for two hour each every day and 5 days per week for 6-12 weeks. Initial assessment will be done within 3 days and the following assessment will be done 6 weeks or 12 weeks after rehabilitation intervention by physician and well-trained therapists. We collect basic data including sex, age, etiology of stroke, affected side, premorbid functional condition, onset time, initial function on admission, Brunnstrom stage, Charlson Comorbidity Scoring and intensity of rehabilitation. Functional assessment including: Modified Rankin Scale (MRS); Barthel Index; swallowing and feeding function, Mini Nutrition Assessment; Euro QoL-5D; Lawton-Brody IADL Scale; Berg Balance Scale (BBS); Gait speed; 6 minutes walking test; Revised Nottingham sensory assessment(RNSA); Mini-mental state examination (MMSE); Motor Activity Log(MAL); Canadian Occupational Performance Measurement(COPM); aphasia evaluation. Data analysis will be done by two-way ANOVA, paired t test, regression and multiple variant analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Diseases
Keywords
Post Acute Care(PAC), Cerebrovascular diseases

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Comorbidity_Comprehensive Rehabilitation
Arm Type
Other
Arm Description
Charlson Comorbidity Index contains 19 categories of comorbidity and predicts the ten-year mortality for a patient who may have a range of co-morbid conditions Each condition is assigned with a score of 1,2,3 or 6 depending on the risk of dying associated with this condition. For a physician, it is helpful in knowing how aggressively to treat a condition. Higher scores indicating greater comorbidity (patients with a score > 5 have essentially a 100% risk of dying at one year).
Arm Title
MRS_Comprehensive Rehabilitation
Arm Type
Other
Arm Description
The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death.
Arm Title
MMSE_Comprehensive Rehabilitation
Arm Type
Other
Arm Description
The mini mental state examination (MMSE) is the most commonly used instrument for screening cognitive function. This examination is not suitable for making a diagnosis but can be used to indicate the presence of cognitive impairment, such as in a person with suspected dementia or following a head injury. The examination has been validated in a number of populations. Scores of 25-30 out of 30 are considered normal; the National Institute for Health and Care Excellence (NICE) classifies 21-24 as mild, 10-20 as moderate and <10 as severe impairment. The MMSE may not be an appropriate assessment if the patient has learning, linguistic/communication or other disabilities (eg, sensory impairments).
Arm Title
BSRS_Comprehensive Rehabilitation
Arm Type
Other
Arm Description
Brief Symptom Rating Scale is a rating scale which a clinician or researcher may use to measure psychiatric symptoms such as depression, anxiety, hallucinations and unusual behavior. Each symptom is rated 1-7 and depending on the version between a total of 18-24 symptoms are scored. The scale is the one of the oldest, widely used scales to measure psychotic symptoms and was first published in 1962.
Intervention Type
Other
Intervention Name(s)
Comprehensive Rehabilitation
Intervention Description
Comprehensive rehabilitation programs including PT, OT or ST will be done for two hour each every day and 5 days per week for 6-12 weeks. Initial assessment will be done within 3 days and the following assessment will be done 6 weeks or 12 weeks after rehabilitation intervention by physician and well-trained therapists.
Primary Outcome Measure Information:
Title
Barthel Index improvement
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stroke patients who suffer from stroke within one month and have potential of rehabilitation PT, OT or ST will be done for two hour each every day and 5 days per week for 6-12 weeks. Exclusion Criteria: Onset over 6 months
Facility Information:
Facility Name
Taipei City Hospital
City
Taipei
ZIP/Postal Code
111
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
18556582
Citation
Rost NS, Smith EE, Chang Y, Snider RW, Chanderraj R, Schwab K, FitzMaurice E, Wendell L, Goldstein JN, Greenberg SM, Rosand J. Prediction of functional outcome in patients with primary intracerebral hemorrhage: the FUNC score. Stroke. 2008 Aug;39(8):2304-9. doi: 10.1161/STROKEAHA.107.512202. Epub 2008 Jun 12.
Results Reference
background
PubMed Identifier
3558716
Citation
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
Results Reference
background
PubMed Identifier
10717521
Citation
Extermann M. Measuring comorbidity in older cancer patients. Eur J Cancer. 2000 Mar;36(4):453-71. doi: 10.1016/s0959-8049(99)00319-6.
Results Reference
background
PubMed Identifier
12725876
Citation
de Groot V, Beckerman H, Lankhorst GJ, Bouter LM. How to measure comorbidity. a critical review of available methods. J Clin Epidemiol. 2003 Mar;56(3):221-9. doi: 10.1016/s0895-4356(02)00585-1.
Results Reference
background
PubMed Identifier
21799172
Citation
Bar B, Hemphill JC 3rd. Charlson comorbidity index adjustment in intracerebral hemorrhage. Stroke. 2011 Oct;42(10):2944-6. doi: 10.1161/STROKEAHA.111.617639. Epub 2011 Jul 28.
Results Reference
background
PubMed Identifier
15232123
Citation
Goldstein LB, Samsa GP, Matchar DB, Horner RD. Charlson Index comorbidity adjustment for ischemic stroke outcome studies. Stroke. 2004 Aug;35(8):1941-5. doi: 10.1161/01.STR.0000135225.80898.1c. Epub 2004 Jul 1.
Results Reference
background
PubMed Identifier
23850613
Citation
Seematter-Bagnoud L, Lecureux E, Rochat S, Monod S, Lenoble-Hoskovec C, Bula CJ. Predictors of functional recovery in patients admitted to geriatric postacute rehabilitation. Arch Phys Med Rehabil. 2013 Dec;94(12):2373-2380. doi: 10.1016/j.apmr.2013.06.024. Epub 2013 Jul 10.
Results Reference
background

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Functional Recovery Effects on Comprehensive Rehabilitation for Post-acute Care -Cerebrovascular Diseases

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