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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01829776
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : November 4, 2014
Sponsor:
Information provided by (Responsible Party):
Michelle Cameron, Oregon Health and Science University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Educational intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Study on the Effect of the Free From Falls Program on Falls in People With Multiple Sclerosis
Study Start Date : April 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Relationship between paper and electronic fall calendars [ Time Frame: 5 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829776


Locations
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United States, Oregon
Oregon Health and Science University and Portland VA Medical Center
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Michelle H Cameron, MD, PT Oregon Health & Science University, Portland VA Medical Center
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Responsible Party: Michelle Cameron, Neurologist, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01829776    
Other Study ID Numbers: 9257
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: November 4, 2014
Last Verified: November 2014
Keywords provided by Michelle Cameron, Oregon Health and Science University:
Accidental falls
Multiple Sclerosis
Education
Exercise
Postural balance
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases