Balance and Gait Characteristics to Predict Accidental Falls in Community-dwelling Stroke Elderly

April 4, 2013 updated by: Ta-Sen Wei,MD, Changhua Christian Hospital

Background: Accidental falls result in major physical and psychological morbidity in the elderly, especially stroke patients. To get optimal prevention of stroke falls, it is crucial to identify independent risk factors from multivariate analysis of related balance and gait parameters.

Aim: To evaluate the effects of balance and gait characteristics in determining whether or not accidental falls may happen. To investigate if the balance and gait parameters affect the time from lesion to when (and if) patients suffer from falls. To compare differences of balance and gait parameters in accidental fall patients between those with severe accidental injuries and those without severe injuries.

Methods: The 2-year observational cohort study will enroll 706 elderly stroke patients, who have not had a previous stroke. They will be retrieved from the Inpatient department and followed-up regularly in the Outpatient department when they are discharged. All subjects will be evaluated at 1 month and 6 months after stroke. These evaluations will include: mental, cognition and depression status; lower-limb muscle strength assessed by a dynamometer as well as range of motion of joints assessed by a biaxial electro-goniometry; functional independence measure; balance and gait pattern will be assessed by both clinical observation and objective laboratory examination (a dynamic posturography and computerized gait analysis system); falls and fall-related injuries during the proceeding year. Differences in baseline characteristics are tested by one-way ANOVA, Mann Whitney U or t tests, if appropriate. The investigators will identify the independent risk factors of accidental falls with logistic regression and use the log rank statistic of Kaplan-Meier survival curve to differentiate the risk of accidental falls or fall-related injuries in different groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Changhua, Taiwan, 500
        • Changhua Christian Hospital Taiwan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

first-ever stroke patients were retrieved from the Inpatient department and followed-up regularly in the Outpatient department when they are discharged

Description

Inclusion Criteria:

  • age>65
  • confirmed stroke by CT or MRI
  • first-ever stroke
  • with walking ability after stroke onset 1 month

Exclusion Criteria:

  • fall history before stroke
  • living in nursing home
  • unstable physical sign
  • seizure attack during study
  • impaired cognition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
accidental falls
Behavioral: accidental falls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Computerized balance evaluation
Time Frame: 1 month after the first stroke
computerized balance and gait evaluation by a posturography and gait analysis system
1 month after the first stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geriatric Depression Scale
Time Frame: 1 month after the first stroke
Geriatric Depression Scale to measure depression
1 month after the first stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhua Christian Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

April 3, 2013

First Submitted That Met QC Criteria

April 4, 2013

First Posted (Estimate)

April 5, 2013

Study Record Updates

Last Update Posted (Estimate)

April 5, 2013

Last Update Submitted That Met QC Criteria

April 4, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I050309

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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