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

Sponsor
Taipei City Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02311036
Collaborator
(none)
165
1
4
18
9.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Comprehensive Rehabilitation
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 1, 2014
Anticipated Primary Completion Date :
Jan 1, 2016
Anticipated Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Other: 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.

Other: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Barthel Index improvement [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taipei City Hospital Taipei Taiwan 111

Sponsors and Collaborators

  • Taipei City Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
MUJUNG KAO, Director, Taipei City Hospital
ClinicalTrials.gov Identifier:
NCT02311036
Other Study ID Numbers:
  • TCHIRB-1030404
First Posted:
Dec 8, 2014
Last Update Posted:
Dec 8, 2014
Last Verified:
Dec 1, 2014
Keywords provided by MUJUNG KAO, Director, Taipei City Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 8, 2014