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Stratification of Stroke Rehabilitation: 5-year Profiles of Functional Outcomes

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ClinicalTrials.gov Identifier: NCT03279848
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Bryan Ping Ho CHUNG, Tai Po Hospital

Tracking Information
First Submitted Date August 31, 2017
First Posted Date September 12, 2017
Last Update Posted Date September 12, 2017
Actual Study Start Date January 1, 2011
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 10, 2017)
Change in Modified Rivermead Mobility Index (MRMI) [ Time Frame: baseline and 1 month ]
MRMI was used to assess subjects' mobility in this study. The MRMI is highly reliable between raters (ICC= 0.98) and has high internal consistency (Cronbach's alpha = 0.93) to early stage patients with stroke. The MRMI consists of eight test items, including turning over, changing from lying to sitting, maintaining sitting balance, going from sitting to standing, standing, transferring, walking indoors, and climbing stairs. The score of MRMI range from 0 to 40. One main characteristic of the MRMI is that participants are scored by observation of their performance on the items directly. Change in MRMI i.e. MRMI gain is the difference between pre-discharge MRMI and admission MRMI.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 10, 2017)
Change in Modified Barthel Index (MBI) Gain [ Time Frame: baseline and 1 month ]
MBI was used to assess subjects' basic activities of daily living (ADL) in this study. MBI measures the subject's performance on ten functional items including self-care, continence, and locomotion. The values assigned to each item are based on the amount of physical assistance required to perform the task and added to give a total score ranging from 0 to 100 (0 = fully dependent, 100 = fully independent) with higher score indicating higher levels of physical function. There are no subtotal score because there are no sub-scales. The internal consistency reliability coefficient for MBI is 0.90. Change in MBI i.e. MBI gain is the difference between pre- discharge MBI and admission MBI.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stratification of Stroke Rehabilitation: 5-year Profiles of Functional Outcomes
Official Title Stratification of Stroke Rehabilitation: 5-year Profiles of Functional Outcomes
Brief Summary

Objective: To make use of admission Modified Functional Ambulation Category (MFAC) as a stratification tool to reveal profiles of functional outcomes of patients with stroke in inpatient rehabilitation.

Design: This was a retrospective, descriptive study of the demographic, functional outcomes of patients with stroke in an inpatient rehabilitation centre. A total of 2,722 patients completed a stroke rehabilitation program from 2011 to 2015 were recruited.

Detailed Description

Objective: To make use of admission Modified Functional Ambulation Category (MFAC) as a stratification tool to reveal profiles of functional outcomes of patients with stroke in inpatient rehabilitation.

Design: This was a retrospective, descriptive study of the demographic, functional outcomes of patients with stroke in an inpatient rehabilitation centre. A total of 2,722 patients completed a stroke rehabilitation program from 2011 to 2015 were recruited. The patients were divided into seven groups according to their admission Modified Functional Ambulation Category (MFAC). The between-group difference in length of stay (LOS), functional outcomes at admission and discharge including Modified Rivermead Mobility Index (MRMI) and Modified Barthel Index (MBI) as well as MRMI gain, MRMI efficiency, MBI gain and MBI efficiency were analyzed.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration 4 Weeks
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with principal diagnosis of cerebrovascular accident, stroke, or hemiplegia.
Condition Stroke Rehabilitation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 10, 2017)
2722
Original Actual Enrollment Same as current
Actual Study Completion Date June 1, 2016
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with principal diagnosis of cerebrovascular accident, stroke, or hemiplegia and has received and completed stroke rehabilitation program in a hospital in Hong Kong between the periods of 1st January 2011 to 31st December 2015.

Exclusion Criteria:

  • Patients with principal diagnosis of cerebrovascular accident, stroke, or hemiplegia and has received but cannot completed stroke rehabilitation program in a hospital in Hong Kong between the periods of 1st January 2011 to 31st December 2015.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03279848
Other Study ID Numbers 2016.283
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Bryan Ping Ho CHUNG, Tai Po Hospital
Study Sponsor Tai Po Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Tai Po Hospital
Verification Date September 2017