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Stroke RehabilitationNCT03279848

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

An observational study of Stroke Rehabilitation, run by Tai Po Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Stroke Rehabilitation
How many people
2,722 participants
Where
No sites listed yet
Study dates
1 Jan 2011to 1 Jun 2016
How long will I take part?
4 Weeks
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with principal diagnosis of cerebrovascular accident, stroke, or hemiplegia.

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

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.

Read the 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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Other

    Also called Stroke Rehabilitation

    Stroke rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Modified Rivermead Mobility Index (MRMI)

    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.

    Measured: baseline and 1 month

Secondary outcomes (1)

  1. Change in Modified Barthel Index (MBI) Gain

    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.

    Measured: baseline and 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2017
  2. Study start1 Jan 2011
  3. Primary completion31 Dec 2015
  4. Study completion1 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
2,722 participants (actual)
Target duration
4 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT03279848
Sponsor's protocol ID
2016.283
Status last verified
Sep 2017
First submitted
31 Aug 2017
Last updated
12 Sep 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke Rehabilitation, run by Tai Po Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Modified Rivermead Mobility Index (MRMI) (time frame: baseline and 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03279848.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.

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