A Targeted Falls Prevention Program in Rehabilitation In-Patients
1 other identifier
interventional
100
1 country
1
Brief Summary
Falls are a major complication in patients treated in rehabilitation departments, yet studies evaluating different interventions to reduce falls-risk are rare and inconclusive. The aim of the present study is to evaluate the efficacy of a multidisciplinary fall-prevention program to reduce falls and injury in stroke patients treated in a rehabilitation department. All stroke patients consecutively admitted to the department of rehabilitation at Hadassah-Hebrew University Medical Center for a period of one year will be eligible for inclusion. Upon receiving an informed consent subjects will be randomized to the intervention group or the control (convention care) group. There are no exclusion criteria. The Intervention includes group education on risk of falling and safe mobility and transfers; physical therapy of balance training at the patients' bedside twice weekly and medical assessment of medication use (anxiolytics/hypnotics, neuroleptics, antihypertensives and other vasodilators), orthostatic hypotension, urinary frequency/incontinence, delirium and visual problems. Intervention therapy will not be given as an extra time, rather at the same treatment time as the control group. Primary outcomes are rate of falls and related injuries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2009
CompletedFirst Posted
Study publicly available on registry
September 9, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedSeptember 9, 2009
September 1, 2009
1 year
August 25, 2009
September 8, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of falls and fall-related injury
At one year
Study Arms (2)
Falls prevention
EXPERIMENTALControl group
NO INTERVENTIONRoutine rehabilitation treatment
Interventions
Group education on falls risk and mobility and transfers safety; Physical therapy at the subjects' bedside consisting of balance training; Medical assessment - medications use (anxiolytics/hypnotics, neuroleptics, antihypertensives, antiarrhythmics and other vasodilators) with effort to discontinue or reduce dose when possible; orthostatic hypotension - discontinue/reduce dose of related medications; urinary frequency/incontinence - evaluation and treatment; delirium - evaluation and treatment; visual pathology - evaluation and treatment
Eligibility Criteria
You may qualify if:
- All stroke patients admitted to rehabilitation
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Medical Organization
Jerusalem, 91120, Israel
Study Officials
- PRINCIPAL INVESTIGATOR
Yoram Maaravi, MD
Hadassah Medical Organization
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 25, 2009
First Posted
September 9, 2009
Study Start
November 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
September 9, 2009
Record last verified: 2009-09