NCT02311036

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

1.1 years

First QC Date

December 1, 2014

Last Update Submit

December 5, 2014

Conditions

Cerebrovascular Diseases

Keywords

Post Acute Care(PAC)Cerebrovascular diseases

Outcome Measures

Primary Outcomes (1)

  • Barthel Index improvement

    6 weeks

Study Arms (4)

Comorbidity_Comprehensive Rehabilitation

OTHER

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

MRS_Comprehensive Rehabilitation

OTHER

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

MMSE_Comprehensive Rehabilitation

OTHER

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

BSRS_Comprehensive Rehabilitation

OTHER

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

Interventions

Comprehensive RehabilitationOTHER

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 RehabilitationComorbidity_Comprehensive RehabilitationMMSE_Comprehensive RehabilitationMRS_Comprehensive Rehabilitation

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Onset over 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei City Hospital

Taipei, Taiwan, 111, Taiwan

Location

Related Publications (7)

  • 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.

    PMID: 18556582BACKGROUND

  • 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.

    PMID: 3558716BACKGROUND

  • 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.

    PMID: 10717521BACKGROUND

  • 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.

    PMID: 12725876BACKGROUND

  • 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.

    PMID: 21799172BACKGROUND

  • 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.

    PMID: 15232123BACKGROUND

  • 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.

    PMID: 23850613BACKGROUND

MeSH Terms

Conditions

Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 8, 2014

Study Start

December 1, 2014

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations

TW(1)