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A Targeted Falls Prevention Program in Rehabilitation In-Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00973297
First received: August 25, 2009
Last updated: September 8, 2009
Last verified: September 2009
History of Changes
  Purpose

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 Intervention
Accidental Falls
 Other: Multidisciplinary falls prevention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Targeted Falls Prevention Program in Rehabilitation In-Patients

Resource links provided by NLM:

MedlinePlus related topics: Falls Rehabilitation
U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Rate of falls and fall-related injury [ Time Frame: At one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: November 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All stroke patients admitted to rehabilitation

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00973297

Contacts
Contact: Yoram Maaravi, MD 00 972 2 5844474 ymaaravi@gmail.com

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD     00 972 2 6776095     arik@hadassah.org.il    
Contact: Hadas Lemberg, PhD     00 972 2 6777572     lhadas@hadassah.org.il    
Sub-Investigator: Yoram Maaravi, MD            
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Yoram Maaravi, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: YORAM MAARAVI MD, HADASSAH MEDICAL ORGANIZATION
ClinicalTrials.gov Identifier: NCT00973297     History of Changes
Other Study ID Numbers: 151059-HMO-CTIL
Study First Received: August 25, 2009
Last Updated: September 8, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Falls

ClinicalTrials.gov processed this record on May 19, 2013