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A Targeted Falls Prevention Program in Rehabilitation In-Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00973297
Recruitment Status : Unknown
Verified September 2009 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : September 9, 2009
Last Update Posted : September 9, 2009
Information provided by:
Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Accidental Falls Other: Multidisciplinary falls prevention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Targeted Falls Prevention Program in Rehabilitation In-Patients
Study Start Date : November 2009
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls Rehabilitation

Arm Intervention/treatment
Experimental: Falls prevention Other: Multidisciplinary falls prevention
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

No Intervention: Control group
Routine rehabilitation treatment

Primary Outcome Measures :
  1. Rate of falls and fall-related injury [ Time Frame: At one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All stroke patients admitted to rehabilitation

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00973297

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Contact: Yoram Maaravi, MD 00 972 2 5844474

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Hadassah Medical Organization
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD    00 972 2 6776095   
Contact: Hadas Lemberg, PhD    00 972 2 6777572   
Sub-Investigator: Yoram Maaravi, MD         
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: Yoram Maaravi, MD Hadassah Medical Organization
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Responsible Party: YORAM MAARAVI MD, HADASSAH MEDICAL ORGANIZATION Identifier: NCT00973297    
Other Study ID Numbers: 151059-HMO-CTIL
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: September 9, 2009
Last Verified: September 2009
Keywords provided by Hadassah Medical Organization: