Pilot Study of Free From Falls Program in Multiple Sclerosis (FFF)

November 3, 2014 updated by: Michelle Cameron, Oregon Health and Science University

Pilot Study on the Effect of the Free From Falls Program on Falls in People With Multiple Sclerosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University and Portland VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: education
Educational intervention
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fall frequency per month (30 days)
Time Frame: difference between the wait period before the 8 week FFF program and the 8 weeks after the end of the 8 week FFF program
The change in fall frequency between the wait period before the FFF program begins and 8 weeks after the program has ended.
difference between the wait period before the 8 week FFF program and the 8 weeks after the end of the 8 week FFF program

Secondary Outcome Measures

Outcome Measure
Time Frame
Relationship between paper and electronic fall calendars
Time Frame: 5 months
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

  • Principal Investigator: Michelle H Cameron, MD, PT, Oregon Health & Science University, Portland VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

April 9, 2013

First Submitted That Met QC Criteria

April 9, 2013

First Posted (Estimate)

April 11, 2013

Study Record Updates

Last Update Posted (Estimate)

November 4, 2014

Last Update Submitted That Met QC Criteria

November 3, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9257

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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