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

Cerebrovascular Accident Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825486
• Other study ID #: I050309
• Status: Completed
• Phase: N/A
• First received: April 3, 2013
• Last updated: April 4, 2013
• Start date: August 2005
• Est. completion date: July 2007

Study information

• Verified date: April 2013
• Source: Changhua Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2007
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Accidental Falls
• Cerebrovascular Accident
• Stroke

Intervention

Behavioral:
• accidental falls

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital Taiwan	Changhua

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Computerized balance evaluation	computerized balance and gait evaluation by a posturography and gait analysis system	1 month after the first stroke
Secondary	Geriatric Depression Scale	Geriatric Depression Scale to measure depression	1 month after the first stroke