NCT00973297

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

September 9, 2009

Status Verified

September 1, 2009

Enrollment Period

1 year

First QC Date

August 25, 2009

Last Update Submit

September 8, 2009

Conditions

Keywords

Falls

Outcome Measures

Primary Outcomes (1)

  • Rate of falls and fall-related injury

    At one year

Study Arms (2)

Falls prevention

EXPERIMENTAL
Other: Multidisciplinary falls prevention

Control group

NO INTERVENTION

Routine 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

Falls prevention

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Study Officials

  • Yoram Maaravi, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoram Maaravi, MD

CONTACT

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

Locations