Cerebrovascular AccidentNCT01825486
Balance and Gait Characteristics to Predict Accidental Falls in Community-dwelling Stroke Elderly
An observational study of Cerebrovascular Accident and Accidental Falls, run by Changhua Christian Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cerebrovascular Accident, Accidental Falls
- What is being tested?
- accidental falls
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteTaiwan
- Study dates
- Aug 2005to Jul 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: first-ever stroke patients were retrieved from the Inpatient department and followed-up regularly in the Outpatient department when they are discharged
Who may be able to join
- age>65
- confirmed stroke by CT or MRI
- first-ever stroke
- with walking ability after stroke onset 1 month
Who cannot join
- fall history before stroke
- living in nursing home
- unstable physical sign
- seizure attack during study
- impaired cognition
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- accidental falls
- Keywords
- Balance, Gait characteristics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
accidental fallsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| accidental falls | Not described Receives: Behavioral: accidental falls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized balance evaluation
computerized balance and gait evaluation by a posturography and gait analysis system
Measured: 1 month after the first stroke
Secondary outcomes (1)
Geriatric Depression Scale
Geriatric Depression Scale to measure depression
Measured: 1 month after the first stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startAug 2005
- Primary completionJul 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ta-Sen Wei,MD, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825486
- Sponsor's protocol ID
- I050309
- Status last verified
- Apr 2013
- First submitted
- 3 Apr 2013
- Last updated
- 5 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance and Gait Characteristics to Predict Accidental Falls in Community-dwelling Stroke Elderly
- ClinicalTrials.gov ID
- NCT01825486
- Acronym / sponsor ID
- I050309
- Conditions
- Cerebrovascular Accident, Accidental Falls
- Keywords
- Balance, Gait characteristics
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| accidental falls | – | Behavioral: accidental falls |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- first-ever stroke patients were retrieved from the Inpatient department and followed-up regularly in the Outpatient department when they are discharged
Key inclusion criteria (4 listed)
- age>65
- confirmed stroke by CT or MRI
- first-ever stroke
- with walking ability after stroke onset 1 month
Key exclusion criteria (5 listed)
- fall history before stroke
- living in nursing home
- unstable physical sign
- seizure attack during study
- impaired cognition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| accidental falls | Behavioural | accidental falls |
Primary outcome
Computerized balance evaluation
Time frame: 1 month after the first stroke
computerized balance and gait evaluation by a posturography and gait analysis system
1 secondary outcome
Geriatric Depression Scale
Time frame: 1 month after the first stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
Related trials for Cerebrovascular Accident
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident and Accidental Falls, run by Changhua Christian Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computerized balance evaluation (time frame: 1 month after the first stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2013.