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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02311036
Recruitment Status : Unknown
Verified December 2014 by MUJUNG KAO, Taipei City Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
MUJUNG KAO, Taipei City Hospital

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.

Condition or disease Intervention/treatment Phase
Cerebrovascular Diseases Other: Comprehensive Rehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effect and Outcome Predictors on Functional Recovery After Comprehensive Rehabilitation for Post-acute Care -Cerebrovascular Diseases
Study Start Date : December 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Comorbidity_Comprehensive Rehabilitation
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).
Other: Comprehensive Rehabilitation
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.

MRS_Comprehensive Rehabilitation
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.
Other: Comprehensive Rehabilitation
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.

MMSE_Comprehensive Rehabilitation
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).
Other: Comprehensive Rehabilitation
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.

BSRS_Comprehensive Rehabilitation
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.
Other: Comprehensive Rehabilitation
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 Measures :
  1. Barthel Index improvement [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311036


Locations
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Taiwan
Taipei City Hospital
Taipei, Taiwan, 111
Sponsors and Collaborators
Taipei City Hospital
Publications:
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Responsible Party: MUJUNG KAO, Director, Taipei City Hospital
ClinicalTrials.gov Identifier: NCT02311036    
Other Study ID Numbers: TCHIRB-1030404
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014
Keywords provided by MUJUNG KAO, Taipei City Hospital:
Post Acute Care(PAC)
Cerebrovascular diseases
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases