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

Completed

• Conditions: Cerebrovascular Accident; Accidental Falls
• Interventions: Behavioral: accidental falls

• Registration Number: NCT01825486
• Lead Sponsor: Changhua Christian Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Primary Completion: 2006-07
• Study Completion: 2007-07
• Status Verified: 2013-04
• Study First Submitted: 2013-04-03
• Study First Submitted QC: 2013-04-04
• Last Update Submitted: 2013-04-04
• Study First Posted: 2013-04-05
• Last Update Posted: 2013-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
accidental falls	accidental falls	-

Primary Outcome Measures

Name	Time	Method
Computerized balance evaluation	1 month after the first stroke	computerized balance and gait evaluation by a posturography and gait analysis system

Secondary Outcome Measures

Name	Time	Method
Geriatric Depression Scale	1 month after the first stroke	Geriatric Depression Scale to measure depression

Trial Locations

Locations (1)

Changhua Christian Hospital Taiwan; 🇨🇳 Changhua, Taiwan