Clinical trial NCT02311036: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebrovascular Diseases
Keywords: Post Acute Care(PAC)
Cerebrovascular diseases
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
First posted: 2014-12-08
Enrollment: 165
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Barthel Index improvement
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei City Hospital
Study officials:
References:
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