Clinical trial NCT01825486: Balance and Gait Characteristics to Predict Accidental Falls in Community-dwelling Stroke Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrovascular Accident
Accidental Falls
Keywords: Balance
Gait characteristics
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2013-04-05
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Computerized balance evaluation
timeFrame: 1 month after the first stroke
Secondary outcomes:
measure: Geriatric Depression Scale
timeFrame: 1 month after the first stroke
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital Taiwan
Study officials:
References: