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

NCT01825486 | Completed

• 1 other identifier: I050309
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accident; Accidental Falls

Keywords

Balance; Gait characteristics

Outcome Measures

Primary Outcomes (1)

• Computerized balance evaluation

  computerized balance and gait evaluation by a posturography and gait analysis system

  1 month after the first stroke

Secondary Outcomes (1)

• Geriatric Depression Scale

  1 month after the first stroke

Study Arms (1)

accidental falls

Behavioral: accidental falls

Interventions

accidental falls BEHAVIORAL

accidental falls

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Study Sites (1)

Changhua Christian Hospital Taiwan

Changhua, 500, Taiwan

Location

MeSH Terms

Conditions

Stroke

Interventions

Accidental Falls

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Accidents; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: April 3, 2013
• First Posted: April 5, 2013
• Study Start: August 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2007
• Last Updated: April 5, 2013

Record last verified: 2013-04

Locations

TW (1)