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

Cerebrovascular Diseases Clinical Trial

Official title:

Effect and Outcome Predictors on Functional Recovery After Comprehensive Rehabilitation for Post-acute Care -Cerebrovascular Diseases

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02311036
• Other study ID #: TCHIRB-1030404
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 1, 2014
• Last updated: December 5, 2014
• Start date: December 2014
• Est. completion date: June 2016

Study information

• Verified date: December 2014
• Source: Taipei City Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 165
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cerebrovascular Diseases
• Cerebrovascular Disorders

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Taipei City Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (7)

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. — View 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. — View 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. Review. — View Citation

Extermann M. Measuring comorbidity in older cancer patients. Eur J Cancer. 2000 Mar;36(4):453-71. Review. — View 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. Epub 2004 Jul 1. — View 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. — View Citation

Seematter-Bagnoud L, Lécureux E, Rochat S, Monod S, Lenoble-Hoskovec C, Büla CJ. Predictors of functional recovery in patients admitted to geriatric postacute rehabilitation. Arch Phys Med Rehabil. 2013 Dec;94(12):2373-80. doi: 10.1016/j.apmr.2013.06.024. Epub 2013 Jul 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Barthel Index improvement		6 weeks	Yes