Pilot Study of Free From Falls Program in Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Educational intervention

• Registration Number: NCT01829776
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-09
• Study First Posted: 2013-04-11
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-03
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

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Exclusion Criteria

• Serious psychiatric or medical conditions that would preclude reliable participation in the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
education	Educational intervention	Educational intervention

Primary Outcome Measures

Name	Time	Method
Change in fall frequency per month (30 days)	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

Name	Time	Method
Relationship between paper and electronic fall calendars	5 months

Trial Locations

Locations (1)

Oregon Health and Science University and Portland VA Medical Center; 🇺🇸 Portland, Oregon, United States