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Completed

NCT Number: NCT01829776

Pilot Study of Free From Falls Program in 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Motor Activity Nervous System Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health and Science University and Portland VA Medical Center

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Educational intervention

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.

Primary outcomes

  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 outcomes

  1. Relationship between paper and electronic fall calendars

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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

Acronym: FFF

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 11, 2013
Registry last updated
Nov 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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