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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00973297
Other study ID # 151059-HMO-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 25, 2009
Last updated September 8, 2009
Start date November 2009
Est. completion date November 2010

Study information

Verified date September 2009
Source Hadassah Medical Organization
Contact Yoram Maaravi, MD
Phone 00 972 2 5844474
Email ymaaravi@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- All stroke patients admitted to rehabilitation

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of falls and fall-related injury At one year Yes
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