Pilot Study of Free From Falls Program in Multiple Sclerosis

NCT ID: NCT01829776

Last Updated: 2014-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-09-30

Brief Summary

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This pilot study will compare how often people with multiple sclerosis (MS) fall before participating in the Free From Falls (FFF) educational program, during the program, and for 8 weeks after the program. The protocol will also evaluate the accuracy, efficiency and convenience of an email survey to count how often people fall.

Detailed Description

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This pilot study will recruit people with MS who report falling at least twice in the previous 2 months to participate in the FFF program. All subjects will record their falls and injurious falls on a daily basis for at least 3 weeks before the program, during the program and for 8 weeks after the program. The program will consist of a weekly 2 hour session. One hour of the session will be educational and one hour of the program will involve exercise. The outcome of this study will be change in fall rate between the periods before, during and after the program.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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education

Educational intervention

Group Type EXPERIMENTAL

Educational intervention

Intervention Type BEHAVIORAL

This is an 8-week comprehensive fall prevention exercise and education program, with one 2-hour session each week, for people with MS, adapted from a similar program for older adults.

Interventions

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Educational intervention

This is an 8-week comprehensive fall prevention exercise and education program, with one 2-hour session each week, for people with MS, adapted from a similar program for older adults.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* MS of any type
* Age 18 years or older
* Able to walk at least 100 meters with intermittent or unilateral constant assistance (cane, crutch or braces) with or without resting
* Self-reported history of 2 or more falls in the previous 2 months
* Clinically stable MS with no relapses within 30 days
* Willing to provide informed consent
* Fluent in written and spoken English.
* Daily access to email and willing to respond to a daily email questionnaire

Exclusion Criteria

* Serious psychiatric or medical conditions that would preclude reliable participation in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Michelle Cameron

Neurologist, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michelle H Cameron, MD, PT

Role: PRINCIPAL_INVESTIGATOR

Oregon Health & Science University, Portland VA Medical Center

Locations

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Oregon Health and Science University and Portland VA Medical Center

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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9257

Identifier Type: -

Identifier Source: org_study_id

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